Jobs at ONO PHARMA USA, INC.

Position Summary:

The Director, Regulatory Affairs will serve as a Health Authority liaison and Regulatory Project Leader for multiple projects in various stages of development. This individual will establish and communicate regulatory strategies and manage regulatory activities for compounds through all phases of development, post-approval, and for the life-cycle of the products. May have line management and people development responsibilities and will play a key role in growing and shaping the regulatory function.

Responsibilities and Duties:

Serves as a strategic regulatory leader for assigned drug development projects and uses knowledge to advise project teams on regulatory requirements to drive successful regulatory strategies.
Manage the planning, preparation, and submission of complex regulatory dossiers in support of project goals. Lead cross-functional teams to deliver high quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc.
Serve as the primary liaison with Health Authorities for assigned products. Lead preparation of high-quality meeting packages, drive meeting strategy and team preparation. Negotiate with Health Authorities, aid in the interpretation of Health Authority feedback.
Build relationships with internal and external stakeholders and integrate regulatory and drug development knowledge to facilitate ways of working and achievement of project and company goals.
Provide strategic direction to teams, mentor staff, foster staff engagement and development.
Contribute to the generation of policies and to the globalization of work processes.
Maintain knowledge of US, EU and ICH regulatory requirements and guidelines and anticipate, assess and communicate changes in regulatory framework throughout the organization, as relevant.
May be required to perform other duties, as assigned.

Educational Requirements:

This position requires a bachelor’s degree in the life sciences, or the equivalent in work experience. Advanced degrees are preferable.

Experience:

Must possess 8 years of relevant regulatory experience; advanced degrees desirable.
Oncology experience highly preferred.
Must have NDA/BLA experience.
People management experience a plus.

Other Skills and Abilities:

Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace, remotely and in person.
Experience developing global regulatory strategies for products in various stages of development.
Ability to quickly integrate information, think strategically, define and mitigate risk, and prioritize activities among multiple projects.
Work with a sense of urgency to maintain important schedules and timelines.

Language Skills:

Must have excellent communication skills (verbal and written). Must be able to effectively communicate with Health Authorities and with peer group members from diverse cultural backgrounds.

Reasoning Ability:

Strategic thinker, able to interpret complex regulations and apply them appropriately, throughout the product development lifecycle.
Strong analytical skills and problem-solving capabilities.

Systems/Computer Skills:

Experience with document management systems, RIMS.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Business Travel:

The incumbent may occasionally attend meetings at Ono sites, and relevant professional conferences. Travel could be scheduled based upon the needs of the business, up to 15% of the time, barring pandemic restrictions.

Other:

The incumbent may occasionally attend meetings at Ono sites, and relevant professional conferences. Travel could be scheduled based upon the needs of the business, up to 15% of the time, barring pandemic restrictions.
As Ono is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role.

*** Please submit resumes to [email protected] ***

Senior Manager, Statistical Programming

Position Summary:

The Sr. Manager, Statistical Programming serves as a functional lead, working closely with Biostatistics and Data Management and provides support, sharing acquired expertise in CDISC submission standards and statistical programming for clinical development projects and studies. Applies programming methodology to summary and analysis of clinical trial data, developing and utilizing SAS programs to create and validate CDISC Study Data Tabulation Model (SDTM) conformed datasets, Analysis Dataset Model (ADaM) datasets, and Tables, Figures, and Listings (TFLs) as scoped in the Statistical Analysis Plan (SAP) for reporting purposes in the Clinical Study Report. Applying analytical skills, the Sr. Manager, Statistical Programming will seek the best way to summarize complex data and effectively communicate that information in a manner that enables others within OPUS, and as appropriate with external organizations, to gain insights from that clinical data. Provides recommendations as to case report form design, data management and review plans, and analytic strategy, which will be utilized as the basis for, and in support of, operational decisions. Duties will include eSubmission package planning and execution for data submission to global regulatory agencies, and management of Contract Research Organizations (CROs) providing programming support. As part of the submission team, will work to provide rapid responses to inquiries from the FDA and other regulatory authorities. The Sr. Manager, Statistical Programming will promote global data science activities within the Ono US organization (OPUS), liaising with the Data Science departments of Ono corporate headquarter (OPJP), and Ono Pharma UK, LTD. (OPUK).

Responsibilities and Duties:

Serves as functional lead, providing support and sharing technical expertise with other OPUS’ functions, especially the OPUS/OPJP clinical/research scientists engaged in the scientific aspects of the clinical development study/project(s).
Serves as lead study programmer on one or more clinical trials, ensuring the accuracy and reliability of reported results, both internally and external to the company.
Responsible for the development, review, validation, and execution of SAS programs to generate presentation ready TFL outputs, as defined in the SAP, for regulatory submissions and publications.
Provides CDISC data standards expertise, support and advice internally, working primarily with the Data Management and Statistics study team members.
Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standard (custom study specific) datasets as defined in the SAP and other specifications documents.
Responsible for reviewing and providing input on key study-related documents such as the SAP and TFL specifications (mock-ups/shells), as well as documents produced by other functions, such as case report forms, data management and review plans, and data transfer specifications.
Responsible for contributing to all appropriate eSubmission aspects of the study, successfully creating the standard structure for human clinical trial data tabulations and the inclusion of that data in eSubmissions to regulatory authorities. Ensures OPUS eSubmission-related processes are compliant with applicable regulatory requirements. These responsibilities shall include but are not limited to:
- Provides input into the selection of CROs/contractors from an eSubmission perspective in conjunction with the study team and OPUS/ONO PHARMACEUTICAL CO., LTD.(OPJP).
- Providing input to eSubmission related documents, e.g., Study Data Reviewer’s Guide (SDRG), Analysis Reviewer’s Guide (ADRG), define.xml and Study Data Standardization Plan (SDSP).
- Reviewing and approving CROs’ study documentation for eSubmission.
- Actively seeking internal feedback while monitoring the performance and quality of on-going programming work performed by CROs by reviewing the appropriate documentation and by developing internal programs for validation oversight purposes, ensuring that the CROs meet the agreed study plan, contracts and any study specific requirements and timelines within all appropriate eSubmission aspects of the study(s).
- Ensures that data packages meet the required standards for submission to regulatory agencies.
- Provide hands-on programming as per study needs, post-hoc analyses, and rapid response to inquiries by regulatory authorities in a timely manner.
- Responsible for effective and timely communication within the company and to external organizations for successful completion of submission related activities.
Conducts oneself at all times in accordance with OPUS Quality Management System, working practices and Good Clinical Practice/Good Manufacturing Practice regulations, and ensure training in these areas is always kept up to date.
Serves and participates on global task forces and/or working groups, involved in developing global programming standards and/or related processes.
Authors or contributes to the development of Standard Operating Procedures (SOPs) and standard documents related to the implementation of programming standards and eSubmission, as required.
Ensures knowledge transfer throughout and upon completion of the study/project.
Remains current on regulatory changes to the eSubmission process as it applies to Clinical Development. Implement new ideas and processes where applicable.
May be required to perform other duties, as assigned.

Educational Requirements:

This position requires a Bachelor’s degree in Computer Science, Information Technology Systems, Statistics, Biostatistics, Mathematics, Biometrics, Engineering or a related scientific discipline, or equivalent in work experience.

Experience:

At least five (5) years demonstrable programming and/or data analysis experience gained within a pharmaceutical or biotechnology industry or in a contract research organization (CRO). Preferrable to have worked in a global environment.
Possesses subject matter expertise on CDISC data standards and proven experience working with CDISC compliant data.
At least two (2) years of SDTM and ADaM lead experience in the pharmaceutical industry.
Demonstrated knowledge of clinical drug development process.
Thorough knowledge of regulatory requirements for data submissions, specifically the standard structure for human clinical trial data tabulations to be submitted to the regulatory authorities.
Demonstrated proficiency with ICH/GCP guidelines, related programming practices and knowledge of other regulatory guidelines relating to eSubmission.
Demonstrable experience utilizing the Electronic Common Technical Document (eCTD) format for regulatory submissions of applications, amendments, supplements and reports to regulatory authorities.
Experience working individually as well as collectively in a collaborative multi-cultural team environment, under time and resource pressures.

Other Skills and Abilities:

Ability to handle multiple tasks, with competing priorities.
Possesses strong organizational skills, with an ability to manage time and resources to ensure the successful achievement of pre-determined deadlines.
Flexibility in approach, while ensuring the delivery of high-quality work in a dynamic work environment.
Ability to oversee and manage a CRO’s CDISC and ADaM dataset related activities and table/figure/listing programming activities of assigned clinical trials.
Able to interact effectively at all levels within the organization, as well as with external partners and clients.

Language Skills:

Must have excellent communication and presentation skills (written and verbal).
Demonstrated ability to effectively interact with internal team members and external parties that do not possess the knowledge and background to readily understand the application of programming practices to drug development and study outcomes.

Reasoning Ability:

Strong analytical and problem-solving skills.
Utilizes a methodical and detailed approach in the review and consideration of procedures and data, without losing sight of the bigger picture.
Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomes.

Systems/Computer Skills:

Requires strong programming skills in SAS, with SAS Certification preferred; R programming skills are preferable.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.

Other:

As Ono is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.

Business Travel:

This role requires the incumbent to travel, which will be primarily domestic. However, the incumbent may have to occasionally attend meetings at Ono Corporate Headquarters in Japan. Travel will be scheduled based upon the needs of the business, up to 10% of the time.

*** Please submit resumes to [email protected] ***

Senior Director, HEOR & Payer Marketing

Position Summary:

The Sr. Director, HEOR & Payer Marketing is a critical role within the commercial organization. Reporting to the VP, US Market Access, he/she works closely with a cross-functional group including Medical, Account Managers, Marketing, Compliance, Legal, Commercial Operations and external stakeholders to develop HEOR models, budget impact models (value models) to ensure broad patient access. He/She is responsible for the development and execution of HEOR models and payer marketing strategies to secure, maintain and drive optimal access for Ono’s product portfolio. The role is also responsible for short and long-term value proposition including health economics and outcomes planning and modeling. The candidate must be a strategic thinker with a proven ability to drive cross-functional execution both internally and externally.

Responsibilities and Duties:

Build strategies and optimize portfolio value through customer insight, evidence generation, value communication, and govern a disciplined pricing framework for executive decision-making.
Collaborates with cross-functional partners (Brand Marketing, Account Directors, Medical Affairs, and other key internal stakeholders) to develop comprehensive strategies and tactics that align to the brand strategy.
Designs and executes programs for Market Access Excellence to increase market access and HEOR capabilities; leads and supports the design of market access training programs related to Health Economics.
Assist in development of pricing strategies with a focus on value and health economics.
In partnership with Medical develop the value proposition including market research and development of tools and resources that effectively communicate the value of Ono’s products to payers and key customers.
This individual will monitor the changing payer landscape mergers and acquisitions, benefit design trends, strategic account trends, medical loss ratios, quality metrics, and the evolution of the impact of policy changes.
Serve as key member of Market Access leadership team with continuous input into team capabilities, resourcing, and strategic objectives.
Development of strategy programs to support education of physicians/hospitals/practices/patients on matters related to HEOR, reimbursement and market access.
Partners with therapeutic area marketing lead to develop and execute HEOR strategies.
Identify opportunities for solutions to provide improved patient access, i.e., value-based contracts, new partnering models etc.
Partner with Legal and Compliance to ensure that all programs and tools are consistent with the latest laws, guidance, and corporate policies.
Provide proactive market feedback to Market Access and cross functional teams on business trends, competitive updates, industry issues and opportunities.

Educational Requirements:

BA/BS degree required. Advanced degree in Finance, Economics, Health Economics, or a similar discipline is preferred.

Experience:

Minimum of 12+ years’ experience in pharmaceutical, biotech or related industry.
Prefer minimum of 8+ years of experience in the following areas: HEOR development, Managed Care Channel Marketing and or Payer Marketing.
Strong understanding of HEOR modelling, value creating, orphan drug pricing and payer processes.
In-depth knowledge of and hands-on experience in health outcomes, health economics and pricing.
Knowledge of the business models, influence/impact, and decision drivers of U.S. commercial and government payers.
Understanding of reimbursement methodologies utilized by commercial and government payers under pharmacy and medical benefits.
Proven ability of successfully managing complexity, solving problems, and building strong relationships.

Other Skill and Abilities:

Results oriented with excellent analytic, collaboration, communication, and presentation skills.
Strong written and oral communication skills.
Analytic skills including experience in conducting research, data mining, modeling, or contract analysis.
Ability to lead cross-functional teams.

Business Travel:

Up to 30%.

*** Please submit resumes to careers[email protected] ***

Director, Patient Advocacy

Position Summary:

ONO Pharma US (“OPUS”) seeks an experienced, collaborative, and highly motivated leader for the role of Director, Patient Advocacy. The director will be responsible for further developing and implementing the US patient advocacy and engagement strategy as a key member of the Medical Affairs team. The Director, of Patient Advocacy will be responsible for instilling the patient voice into the everyday operations of the company and for bringing critical patient insights to inform strategic decision making. The incumbent will have shared team accountability for setting the advocacy strategy for grants and sponsorships and will work collaboratively with cross-functional teams to ensure an aligned corporate approach to giving. This role will report to the VP Medical Affairs.

Responsibilities and Duties:

Develop and implement a comprehensive patient advocacy and engagement strategy, ensuring that ONO Pharma US establishes strong relationships across multiple serious diseases with a focus in Oncology, Immunology and Rare Diseases.
Create and bring forward innovative approaches to partnering with patient advocacy groups in areas of strategic alignment with a focus on strategic patient engagement, patient-focused drug development, and patient community strengthening.
Support the North American sponsorship and grants strategy for Advocacy, ensuring cross-functional alignment, and manage the budget. Strategically support the development and implementation of policies and systems to effectively execute the giving strategy.
Champion the patient voice and experience internally.
Work collaboratively with Medical, Clinical and cross-functional partners, and integrate patient insights to inform corporate strategies, business critical projects, and key decisions.
Collaborate with Global patient advocacy team and align on strategy.
Develop and lead patient advocacy communications strategies and messaging.
Lead and develop patient advocacy focus groups and related advisory boards, ensuring compliance with all internal and external guidelines.

Educational Requirements:

BS/BA; Masters degree or other advanced degree preferred.

Experience:

15 + years in the pharmaceutical industry with a deep understanding of the unique characteristics of and requirements for pricing and contracting pharmaceutical products.
Proven leader in pricing and access and documented ability to engage Senior Leadership in innovative pricing solutions.
Strong, demonstrated track record of connecting and combining ideas, designing pilots and metrics, and driving novel ideas to practical solutions in pricing.
Understanding of the complex US legal, regulatory, and compliance regulations and guidelines.

Other Skill and Abilities:

Demonstrated ability to build strong and trusting relationships with patient advocacy groups, internal and external stakeholders, consistently delivering a high degree of professionalism, empathy and sensitivity.
Proven team leadership, development, and management skills. Experience building and/or leading in high-performing patient advocacy teams.
Strong planning and organization skills with the ability to set priorities effectively and efficiently, and the ability to manage multiple priorities and stakeholders simultaneously.
Experience developing creative initiatives to enhance patient engagement.
Understanding of the compliance governing patient engagement and interactions, and the drug development process.
Experience working in rare disease patient advocacy.
An entrepreneurial spirit coupled with a drive to embrace innovation and develop creative solutions to challenges.
Ability to serve as a company ambassador with external stakeholders.
Excellent verbal, written, and presentation communication skills and an ability to summarize complex medical and scientific information.

Business Travel:

Ability to travel, estimated 30%

*** Please submit resumes to [email protected] ***

Safety Scientist

Position Summary:

The Safety Scientist will be based in Cambridge and work in collaboration with the Global Safety team. This person will contribute to the safety and risk management activities of the assigned investigational compound(s) and/or marketed product(s), in accordance with the internal procedures and regulatory guidelines.

Responsibilities and Duties:

Participate in the generation of the aggregated safety reports both for development and marketed compounds (PBRER, PSUR, PADER, DSUR, IND annual, NDA annual, ISS, 6 monthly line-listings, etc.), focusing on safety data retrieval and analysis, authoring of some sections, creation or update of appendices, producing tables and figures, QC, etc.
Assist in preparation of product datasheet(s) for assigned investigational drug(s) or marketed product(s) corresponding to the CCDS/CCSI/RSI/IB or local PI.
Assist in reviewing AE/SAE CRF pages and User Acceptance Testing.
Coordinate all aspects of signal detection and safety surveillance and review activities, in collaboration with or as Global Safety Lead /Regional Safety Lead, for assigned product(s).
Perform case report QC, review, follow-up and reportability assessments and input into aggregate safety reports with full technical competence.
Represent pharmacovigilance department in cross-functional teams or committees and external environments at a global and regional level as required.
In depth knowledge and understanding of designated products/studies.
Coordinate, moderate, and clearly document conclusions of cross-functional scientific meetings and take meeting minutes.
Collaborate with and support study teams and other applicable functional area specialists including (but not limited to) Clinical, Medical, Biostatistics, Medical Affairs, Quality, Regulatory Affairs to identify, evaluate and manage safety signals for marketed and investigational products to optimally support alignment in the understanding and interpretation of safety data.
Responsible for taking, circulating, and finalizing meeting minutes for relevant signaling meetings for their assigned product.
Assist the Global Safety team in coordination of the signal detection as well as risk management activities, including kick off activities, planning, safety data retrieval and analysis, authoring of some sections of the Safety Evaluation Report (SER) or Development Safety Evaluation Report (DSER), creation or update of appendices, Quality Control (QC), etc.
Assist the Global Safety team in the safety review and contribute to periodic Quality Control of vendor-generated / databased ICSRs for assigned investigational compound(s) and/or marketed product(s).
Assist the Global Safety team, as needed, in the preparation of Analysis of the Similar Events (AOSE), including retrieval and analysis of the safety data.
Support initiatives outside of the assigned projects/compounds.

Educational Requirements:

Bachelor of Science or Health Care Professional degree (e.g., RN, BSN, NP, PA, RPh) or equivalent degree qualification with a minimum 4 yr. drug safety experience.

Experience:

Experience with development, authorship, and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, ISS, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies.
Excellent working understanding of safety database configuration and adverse event coding to direct advanced searches.
In-depth knowledge of clinical trial methodology, pharmacovigilance domestic and international regulations, safety data analysis and benefit-risk assessment, and understanding of drug development.
Experience in preparation of aggregate reports and signalling activities.
Experience with working in safety database(s) (Argus, ARISG, etc.,).

Other Skill and Abilities:

Good critical/analytical thinking and project management skills.
Ability to review, analyze, interpret, and present complex data to a high standard, with keen attention to detail.
Familiarity with clinical database(s) (Inform, Medidata, etc.,).
Strong Microsoft Excel, Word, and PowerPoint skills.
Advanced written and verbal communication skills.
Strong planning and project management skills.
Ability to successfully prioritize and multi-task operational activities.

*** Please submit resumes to [email protected] ***

Senior Manager, Biostatistics

Position Summary:

In collaboration with project team members, provides statistical/strategic input to the clinical development plan, contributes to protocols, and authors statistical analysis plans for clinical studies. Conducts statistical analyses, and provides statistical interpretation of analysis results, while exerting a high degree of expertise in biostatistics. The incumbent also contributes to reporting clinical study results to regulatory authorities, marketing applications and approvals and serves as an integral member of the clinical development team.

Responsibilities and Duties:

The Senior Manager (SM), Biostatistics is responsible and accountable for the statistical science aspects of clinical studies and projects. The SM will be responsible for effective communication within the company and, where appropriate, with external organizations regarding actions related to the successful completion of statistical activities within the studies/projects.
The SM will lead and manage all statistical activities within clinical studies and projects, including contributing to study design and selection of appropriate data analysis methods, sample size estimation, and working closely with other functional members, external consultants, key opinion leaders, medical advisors and CRO’s/contractors, to ensure the quality and integrity of the data is maintained while identifying, and minimizing where possible, risks to the studies/projects.
Provides appropriate statistical review and interpretation of any pre-clinical data and clinical data from other studies conducted by other parties for the same compound, and/or utilizes Real World Evidence or pragmatic platforms as data sources, as well as data visualization software, for decision making purposes. Identifies relationships and trends in data, as well as any factors that could affect the results of research.
Contributes to and is accountable for the setting up, implementation, and reporting of clinical studies with regard to statistical aspects of the studies. These responsibilities include, but are not limited to: - Providing input into the selection of service providers (SPs)/contractors from a statistical aspect in conjunction with the study team. - Being responsible and accountable for developing and maintaining study documents with regard to statistical aspects of the studies, e.g., including, but not limited to, the Statistical Analysis Plan (SAP). - Providing input to study documents, e.g., a study plan, study protocol, data management plan, operational documents, clinical study report, and/or authoring relevant sections of study documents. - Reviewing and approving SPs’ study documentation for statistical areas. - Managing SPs/contractors and overseeing their performance and quality of work to ensure they meet an agreed study plan, contracts and any study specific requirements with regard to statistical aspects of the studies. - Ensuring data meets the required standards for regulatory submission to applicable agencies (for example, FDA). May include, but not limited to: - Review of data (using tools such as Pinnacle 21) to ensure compliance with CDISC standards (ADaM and Define XML). Review of applicable Reviewers Guides.
Ensures statistics-related processes are compliant with applicable regulatory requirements.
Actively seeks feedback and monitors the quality of statistics SPs work on an on-going basis, through review of appropriate documentation.
Acts as an advisor to clinical/research scientists engaged in the scientific aspects of clinical development studies/projects and provides statistical programming support (via SAS, R, and other packages), as needed.
Ensures knowledge transfer during and at the completion of the studies/projects.
Continues to update knowledge and keep abreast of changes within the field of Statistics in Clinical Development. Implements new ideas and advanced processes, where applicable.
And any other duties, as assigned.
Disclaimer: This Job Description identifies the essential job functions and skills needed by the persons or persons assigned to this position. These functions and skills are not intended to be a complete and exhaustive list of all of the responsibilities, functions, and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions. The information contained herein is subject to change at the Company's discretion and should in no way be construed as an employment contract.

Educational Requirements:

This position requires a Ph.D. or a Master’s degree in Statistics, Mathematics, Biometrics or Medical Statistics or a related discipline, or equivalent in work experience.

Experience:

At least 4 years of statistics experience with a Ph.D. degree or 7 years with a Master’s degree, or the equivalent in work experience within the pharmaceutical industry (including contract research organizations (CROs)), biotechnology or medical sector, including clinical trial design, analysis and reporting. Experience in Phase III pivotal clinical development studies, with submission of marketing applications to regulatory agencies is required.
Demonstrated expertise in the application of statistical methods in drug/device development for the treatment of disease, along with knowledge of health authority standards of statistical analytics. Must possess experience in analysis and interpretation of study results, and authoring of study reports that are accurate and reproducible.
Possesses knowledge and pharmaceutical experience in the creation of clinical development strategic planning and the design and implementation of clinical studies.
Experience with new drug application (NDA) submission to regulatory agencies, specifically concerning the description and analysis of each controlled clinical study, and the integration of summary information about the safety and efficacy (Integrated Summary of Safety and Integrated Summary of Efficacy) of a drug/device product.
Successful track record of managing CROs conducting statistical aspects of clinical trials.
Understanding of and compliance with the principles of GCP guidelines and global regulatory requirements.
Demonstrated knowledge of and experience with FDA regulations and guidelines, in particular statistical analysis and CDISC standards.
Proven experience in all aspects of clinical trial execution with the ability to follow SOPs and accepted practices. Possesses a clear understanding of the work performed by other Clinical Development functions and how they collectively interact and contribute to the drug development process.

Other Skill and Abilities:

Eye for detail, ability to handle multiple tasks, strong organizational skills, with an ability to manage time and resources to ensure the successful achievement of pre-determined deadlines.
Flexibility in approach, while ensuring the delivery of high-quality work in a dynamic work environment, with competing priorities.
Ability to oversee and manage a CRO’s statistical analysis of assigned clinical trials.
Able to interact effectively at all levels within the organization, as well as with external partners and clients.
Proven ability to work independently with minimal supervision, as well as in a multi-cultural team environment.

Language Skill:

Must have excellent communication and presentation skills (written and verbal).
Demonstrated ability to effectively interact with internal team members and external parties that do not possess the knowledge and background to readily understand the application of statistics to drug development and study outcomes.

Mathematical Ability:

Mathematical capabilities required for data analyses.
Mathematical capabilities to review and comprehend statistical data.

Reasoning Ability:

Strong analytical and problem-solving skills.
Utilizes a methodical and detailed approach in the review and consideration of procedures and data, without losing sight of the bigger picture.
Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomes.

Systems/Computer Skills:

Requires strong statistical programming skills in SAS.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.

Other:

As ONO is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.

Physical Demands:

Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g. in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).

Work Environment:

The noise level in the work environment is usually quiet.

Business Travel:

This role requires the incumbent to travel, which will be primarily domestic. However, the incumbent may have to occasionally attend meetings at ONO Corporate Headquarters in Japan. Travel will be scheduled based upon the needs of the business, up to 10% of the time.

*** Please submit resumes to [email protected] ***

Associate/Director, Medical Affairs

Position Summary:

The Associate or Director, Medical Affairs will report to VP, Medical Affairs is responsible for identifying unmet medical needs and developing and executing Medical plan and tactics in primary central nervous system lymphoma (PCNSL) and other future indications in the hematologic malignancies area of ONO’s assets, which to support development and commercialization of ONO product(s). He/she will be working closely with the MSL director to leverage medical insights to develop medical plan and work collaboratively with multiple internal stakeholders including Development, Commercial, HEOR in the responsible therapeutic area.

Responsibilities and Duties:

Supports the development of US Medical Plans under supervision of the VP Medical Affairs and ensures execution of medical affairs tactics in the hematologic malignancies area, to support development and commercialization of ONO product(s), which includes data generation plan, medical publication plan, and medical education plan.
Plan and execute medical advisory boards in the US within responsible area as needed to obtain insight for medical activities.
Leverage medical and scientific insights to develop medical plan for ONO product(s) in hematologic malignancies area.
Supports the US field medical teams through the development of scientific communication plan and tools to address healthcare provider needs, and ensures MSL teams are fully trained on the resources by collaborating with MSL lead.
Develop the KOL relationship. Assist in the selection of external stakeholders and maintain key relationships, identify relevant programs for congresses and conferences.
Develop and deliver scientific presentations to both internal and external stakeholders in the meeting, advisory boards and medical congress, and participate in investigator meetings as necessary in the therapeutic area.
Support and coordinate patient advocacy activities and tactics.
Develop and execute of US symposium and educational meetings within the area. Plan and execute disease awareness campaign for PCNSL and other future indications.
Develop a strategic data generation plan in hematologic malignancies area for Medical Affairs sponsored trials including phase IIIB/IV trials and real world evidence in the US that address existing and future data gaps and support reimbursement needs. Support HEOR team to design and conduct health economic studies.
Participate in the development, execution and management of Investigator Sponsored Trial (IST) strategy for respective disease areas. Support to develop review and approval process of ISTs.
Develop and manage medical publication plans with Publication team. Collaborate across the organization to create publication strategies for each clinical program and manage their execution.
Develop scientifically accurate materials for medical education programs, advisory boards, and symposium. Maintains an up-to-date analysis of competitor product information.
Ensures budgets, timelines, compliance requirements are factored into medical activities.
Work collaboratively with global and each country’s therapeutic leads including Japan, Korea, Taiwan and ONO’s future affiliates to set a common medical objective and share medical activities and experience.
Work collaboratively with the Clinical Development, Regulatory Affairs, Commercial, Legal and Finance organizations.
Support the Development team to conduct expanded access program of our products in hematologic malignancies area.
Provide scientific and medical advice to develop study synopsis, protocols and study reports, including health economic & outcomes research (HEOR) related studies.
Provide oversight of medical approval of promotional and non-promotional materials.
Oversight of the review and approval of Medical Information response letters.
Support medical needs related to new licensed products for the US.
May be required to perform other duties, as assigned.

Educational Requirements:

Requires advanced degree (M.D. PhD or PharmD, Nurse Practitioner) in a scientific discipline.

Experience:

Requires at least 3-5 years of pharmaceutical or related industry experience (HealthCare Agencies), of which the majority must be in medical affairs in the US, possessing clinical trials experience with expertise in the therapeutic area of oncology is a plus.
Requires hematology malignancies and oncology knowledge and experience.
Solid understanding of clinical trial designs and drug development process and experience of Medical Affairs sponsored clinical trial for hematology malignancies products.
Requires experience and success in working in a matrix, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results.
Remain current and ensure adherence to the highest ethical, scientific, and regulatory standards.

Other Skill and Abilities:

Possessing interpersonal skills and a positive attitude, with an ability to effectively interact at all levels of the OPUS organization, as well as with external parties.
Strong interpersonal skills commensurate with the need to work closely with healthcare professionals, and team members across functions.
Work experience across multiple cultures and countries.
Highly detailed and quality oriented.
Ability to persuade and collaborate with project team members and senior management.
A positive attitude, flexibility and a proactive thought process.

Language Skill:

Must have excellent communication and presentation skills (verbal and written). Serving as a subject matter expert and resource, must be able to effectively present to and connect with the members of an audience, which may be made up of OPUS team, KOLs, investigators, representatives of a regulatory agency, patients, and Japan parent company’s stakeholders.

Reasoning Ability:

Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources to achieve desired outcomes.
Strong analytical skills and problem-solving capabilities. Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to interpret an extensive variety of technical information and deal with several abstract and concrete variables.

Systems/Computer Skills:

Proficient in Microsoft Office (Word, Excel, PowerPoint).

Other:

As Ono is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning, or on weekends.

Physical Demands:

Work is generally sedentary in nature, but may require standing and walking. Requires reaching grasping, lifting and moving materials and/or office equipment up to 15 pounds (e.g. in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).

Work Environment:

The noise level in the work environment is usually quiet.
Domestic and international travel includes spending time at cancer trial sites/institutions, scientific and medical conferences, offices and hotels.

Business Travel:

This role requires the incumbent to travel domestically and internationally on a reasonably frequent basis, including some weekend travel, occasionally to attend meetings at Ono Corporate Headquarters in Japan and attend international medical conferences, for example, advisory boards, etc. Travel will be scheduled based upon the needs of the business, up to 50% of the time.

*** Please submit resumes to [email protected] ***

Senior Manager, Accounting

Position Summary:

The Sr. Manager, Accounting is responsible for the general accounting functions for OPUS, as a subsidiary of Ono Pharmaceuticals, Inc. The position is responsible for preparing, processing and managing monthly / quarterly / annual accounting closing packages for Parent Company by collaborating with internal stakeholders and external business partners in a timely manner.

Responsibilities and Duties:

General Accounting

Develop and maintain internal controls.
Record, reconcile and analyze general ledger accounts.
Manage regular and ad hoc general journal entries and reconciliations.
Generate, prepare and review monthly financial statements/packages.
Manage employees expense report and Concur system.
Participate in internal and external financial and operational audits.
Support and prepare documentation for internal/external auditors and respond to questions from auditors.

Cost Accounting

Develop and maintain cost accounting procedures.
Build cost standards for materials and labor.
Designing and implementing cost accounting system.
Analyzing production costs and recommending changes.
Overseeing annual physical inventory.
Analyze inventory risk for obsolescence and maintain accounting of inventory reserves.

Tax

Support external tax professionals for tax return, quarterly provision, and other foreign tax filings.
Ensure compliance with local, state, and federal government reporting requirements (use, transfer pricing and withholding tax, etc.)
Work with external tax professionals to: ①Develop tax accounting policies, procedures and controls ②Review quarterly and annual income tax provisions prepared by tax professionals ③Review tax journal entries prepared by tax professionals ④Prepare and review effective tax rate, tax account reconciliations, tax account analysis, and tax reserves etc. ⑤To identify, analyze, and document company tax positions and impact of any legislative changes

Others

Ad Hoc reporting and analysis to support the financials and other projects.
Prepare and submit necessary information to other department as requested.
Perform special projects as required.
May be required to perform other duties, as assigned.

Educational Requirements:

This position requires a bachelor’s degree in business, with a focus on finance and/or accounting. CPA and/or MBA are preferred.

Experience:

Must possess at least five (5) years of cost accounting, general accounting, and tax experience within the pharmaceutical industry.
Prior experience in manufacturing / cost accounting for Pharmaceutical Products.
2 – 5 years of tax provision and compliance experience is preferred.
Knowledge of US GAAP, tax accounting, and federal and state tax laws.
Knowledge of IFRS is preferred.

Other Skill and Abilities:

Able to balance strategic approach with the needs of an organization requiring hands-on work, while addressing competing and/or shifting priorities that may require, at times, a sense of urgency.
Strong accounting, analytical, computer skills and communication skills are required.
Ability to work cross functionally through complex business projects.
Demonstrates the ability to gain cooperation and alignment.
Demonstrates appropriate judgment and ability to make sound decisions in keeping with the company’s philosophy and values.
Supports an environment that encourages ownership, accountability, teamwork and motivation.
Ability to manage highly confidential material in an appropriate manner.
Proven ability to work with a high degree of energy, accuracy and attention to detail.
Ability to interact and communicate effectively at all levels across an organization, be detailed and deadline-oriented, with a demonstrated ability to handle multiple tasks with varying priorities.

Language Skill:

Must have excellent communication and presentation skills (verbal and written).

Mathematical Ability:

Proficient in basic math skills (e.g., calculating averages, percentage changes, and using margin and mark up information (for use in profit and loss calculations)).
Accounting and Financial Reporting based on Generally Accepted Accounting Principles (GAAP).
Proven ability to perform account reconciliations and create supporting financial schedules.

Reasoning Ability:

Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomes.
Strong analytical skills and problem-solving capabilities.

Systems/Computer Skills:

Advanced experience with MS Word, MS Excel, MS PowerPoint, MS Outlook and similar programs. Familiarity with MS Access would also be a plus.
Intermediate to advanced knowledge of major accounting software packages for both general ledger and statutory accounting.
Experience with accounting systems such as Quickbooks, SAP, Oracle, Concur, and etc. would be a plus.

Other:

As Ono is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.

Physical Demands:

Work is generally sedentary in nature, but may require standing and walking. Requires reaching grasping, lifting and moving materials and/or office equipment up to 15 pounds (e.g. in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).

Work Environment:

The noise level in the work environment is usually quiet.

Business Travel:

This role may require the incumbent to travel, which will be primarily domestic. Travel will be scheduled based upon the needs of the business.

*** Please submit resumes to [email protected] ***

Associate Director, Digital and IT

Position Summary:

Ensure that Corporate IT systems are developed and introduced in accordance with business requirements and managed, reviewed, introduced in compliance with IT Governance, GDPR and GxP, as well. Ensure the Company meets all its statutory and compliance duties, issues, and requirements in relation to IT provision.
Participate in the management and oversight, directly or via helpdesk of 3rd party vendors, of all end user support issues in Corporate IT areas including; all hardware and software related isses, all meeting support requiring audio, web conferencing and IT technical support.
Ensure appropriate IT-related processes and procedures are established and maintained. Supports OPUS management in IT related issues, ensuring they keep up to date on changes to relevant legislation, guidelines and regulations and technology that OPUS uses and learning new technologies that benefits OPUS’s future strategy. Keeping OPUS management and staff up to date on any IT related information.
Liaise with HQ IT where necessary to set up/update/remove accounts, manage Corporate IT and to improve security. Establish and maintain a positive relationship with Ono Pharma HQ IT Division and initiate/support the development of a Global IT environment, working in partnership with all regions.
Participate in management and accountability for IT activities conducted for and on behalf of the company by third party contractors and service providers.

Responsibilities and Duties:

Deliver a comprehensive Corporate IT service to OPUS in the following areas.
　　　
- Participate in improvement initiatives of the company's system related processes with Business Process Owners and Power Users.
- Recognize and improve the company's use of the global IT Systems, using best practice and standard delivered solutions.
- Design and agree functional specifications to meet new business requirements, including defining technical specifications for developers.
- Perform unit testing to ensure functional requirements are met.
- Support business users as necessary during QA acceptance testing.
SAP
SAP Specific responsibilities but not limited to:
　　　
- Participate in and advise ERP Global and Regional Governance Teams on decisions, leading to common/compatible solutions.
- Work with SAP- CoE and other IT resources to advise and ensure the technical solutions will meet functional requirements for the company.
- Design, configuration and testing of core SD, MM, FI, CO modules.
- Undertake configuration of SAP where necessary for solution delivery.
Workday
Responsible for the management of workday including but not limited to:
　　　
- Web Services Integration Development - Investigate the business and technical requirements for the Workday HCM services.
- Performs Workday implementation tasks, design, configuration and testing of each modules, such as performance management, payroll, recruiting(ATS), learning management, etc.
- Develops and conducts data integrity on ADP data for Workday implementation.

Educational Requirements:

Bachelor’s Degree or IT related diploma or related experience.

Experience:

5+ years of experience working in a directly related role with SAP responsibilities. Some Workday or other HRIS experience needed. Working in the pharmaceutical industry is a significant advantage, along with working with GxP compliance and working in a regulatory environment.
Demonstrable technical and operational support experience.
Demonstrable experience developing and documenting IT processes (e.g. Standard Operating Procedures).
Must be diplomatic, flexible, and tactful in liaising with staff, management, and senior management.
Experience working in a team environment under time and resource pressures.
Excellent project management and time management skills, a flexible approach and ability to adapt in a constantly changing environment.
Able to organize and oversee multiple on-going tasks, understanding and giving appropriate weight to differing priorities.

Other Skill and Abilities:

Ability to effectively lead, motivate, coach, and manage people indirectly when required and where necessary manage projects that include cross-functional teams.
Self-sufficient with the ability and IT experience to work independently with minimal supervision. Comfortable to work in a changing environment that is evolving in line with business growth.
A can-do attitude with a willingness to get actively involved both within IT activities and wider business issues.
Ability to build rapport quickly with key members of the Global IT team.

Language Skill:

Excellent English oral and written communication. Good interpersonal and communication skills when dealing with internal and external clients/vendors, supporting colleagues, and making presentations.

Mathematical Ability:

Mathematical capabilities required for Budget management and calculations.

Reasoning Ability:

Demonstrated ability to effectively manage and problem-solve several complex projects with rigorous timelines; provides high quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.

Systems/Computer Skills:

SAP Certification *Preferred
Workday Certification *Preferred

Other:

Able to provide IT support outside of normal business hours when required.
Must understand, respect, and maintain the confidential nature of all information that the incumbent may be privileged to within this role. Always maintain discretion and confidentiality.

Physical Demands:

Sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling may be required.

Work Environment:

The noise level in the work environment is usually quiet.

Business Travel:

This role may require the incumbent to travel, which will be primarily domestic, Travel will be scheduled based upon the needs of the business, up to 10% of the time.

*** Please submit resumes to [email protected] ***