Jobs at ONO PHARMA USA, INC.

Director, Regulatory Affairs

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] ***

Sr. 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.

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] ***

Sr. Manager, Clinical Science

Position Summary:

Utilizing OPUS’ clinical development strategy, while complying with pharmaceutical industry practices and regulatory guidelines, serves as a Sr. Manager of Clinical Science on the Clinical Research and Development team, responsible for leading or supporting the design, data collection and clinical studies, reporting activities that comprise the development and design of a clinical drug program/portfolio, to determine the drug’s efficacy, based on the interpretation of trial results.

Responsibilities and Duties:

  • Serves on the clinical development team, working collaboratively with Project Leader(s) and the Medical Director(s) to develop the clinical development plan for the designated indication. Responsible for the writing of clinical documents, which may include clinical protocols and associated amendments, charters, safety monitoring plans, process documents, scientific manuscripts and abstracts, posters and scientific presentations, briefing documents, IND reports, clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates and the clinical sections of regulatory submissions to support product approvals, etc.
  • Gathers clinical data ensuring that the clinical development process utilized is aligned with strategic objective(s), as well as regulatory reporting requirements (working with biostatistics and data management). Plan for interim data analyses and reviews. Monitors and evaluates emerging clinical data, reviewing, analyzing and interpreting study data, presenting study-related scientific and medical data as a basis for the development and design of the clinical drug program or portfolio.
  • Selects and develops the clinical outcome measure, completing the data review, and undertaking the subsequent clinical trial activities.
  • Select/liaise with extramural consultants (i.e. Data Safety Monitoring Board and Steering Committees).
  • Reviews and interprets data, producing abstracts, presentations and manuscripts.
  • Contribute to development of the clinical protocol by performing medical literature and new technology reviews, seeking input from various R&D functions.
  • Collaborates with the Medical Director(s), clinical operations, and other R&D organizations to conduct clinical review of the study data; reviewing and discussing the clinical study reporting documentation, and as the studies end, securing the data and completing the study reporting.
  • Collaborates with other functions to: develop and implement the overall data quality plan; to review safety narratives and other safety-related guidelines and documentation, while tracking, analysing, and reporting any potential safety events.
  • May serve as the study point-of-contact regarding questions associated with an assigned study (ies) or program(s) coming from internal functions, such as clinical operations, or externally from a CRO.
  • Remains current on scientific developments, trends and innovative practices that may impact the clinical development organization and the work that the members individually and collectively perform, so as to develop a current understanding and outlook regarding internal and/or external influences, and their implication on OPUS’ studies.

Educational Requirements:

  • This position requires a Bachelor’s degree, in the Life Sciences, or the equivalent. An advanced scientific degree (e.g., Master’s Degree in Science, a PhD or PharmD) is preferred. Possessing a strong scientific background in the therapeutic area of Immunology is preferred.

Experience:

  • Possesses a strong scientific background, having five to seven years pharmaceutical industry experience in clinical drug development and the associated regulatory processes. Has extensive knowledge in clinical research, understanding the design and management of clinical trials. Previous experience across Phase I-III drug development projects is required, with a focus on Immunology product development. Academic drug development experience will be considered.
  • Demonstrated understanding of and the experience supporting clinical trial design, having been responsible for developing essential documents (such clinical trial protocols, protocol amendments, case report forms, etc.), along with the driving the execution of the clinical study(s).
  • Project planning skills, focusing on realistic, efficient, and effective plans.
  • Utilizing attention to detail, and strong organizational skills, has established a successful track record managing the clinical strategy and the associated study(s), ensuring the necessary data collection documentation is accomplished for the required analysis and interpretation of clinical trial results.
  • Possesses technical expertise and knowledge of Immunology, specifically the drug compound and the emergence of new technologies and advancements in the care of the patient and treatment of Autoimmune diseases, so as to have the credibility to serve as an OPUS liaison with internal/external partners (clinical investigators, key opinion leaders (KOLs), medical directors, etc.).
  • Subject matter expert with a strong analytic background, and compelling written and verbal communication skills, capable of presenting clinical data and complex findings to team members and members of senior management/decision makers, as well as external audiences and/or experts.
  • Recognizing the value of working cross-functionally, demonstrated ability to operate collaboratively to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives, maintaining an awareness of regulatory requirements, as well as commercial objectives.
  • Knowledge of regulatory guidelines and standards (GCP, ICH and regulatory agency (FDA) guidelines).

Other Skill and Abilities:

  • Possesses ability to author scientific documents, including documentation supporting regulatory submissions.
  • High performing and able to work independently, organizing priorities and managing project timelines, while possessing the necessary interpersonal skills and strong analytical skills that enable the successful team collaboration so as to accomplish OPUS’ clinical strategy.

Reasoning Ability:

  • 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).
  • Ability to read printed materials and written information on a computer screen is required.

Systems/Computer Skills:

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

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 based upon the needs of the business, up to 30% of the time.

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 Medical Writer

Position Summary:

As a Senior Medical Writer, you will be empowered to formulate and execute the writing strategy for key clinical and regulatory documents and regulatory submissions.

Responsibilities and Duties:

  • Performs medical writing activities for key clinical and regulatory documents and regulatory submissions.
  • Provide functional and cross-functional guidance on a wide range of issues related to document preparation, including US and international regulatory guidance and requirements for content and format, Company requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
  • Assume primary responsibility for preparation of key clinical and regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities.
  • Formulate writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area.
  • Coordinates the selection of vendors and independent contractors for outsourced medical writing activities.
  • Coordinates assignments for internal and outsourced medical writing activities
  • Sets expectation for, guides and oversees outsourced document preparation. Collaborate with internal and external resources to achieve high quality, timely program level submission deliverables.
  • Provides review and substantive editing of documents.
  • Represent Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
  • Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements.
  • Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
  • Manage deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and Company requirements and processes across development programs.

Educational Requirements:

  • A minimum of a Bachelor’s degree in a relevant scientific/clinical/regulatory field is required.

Experience:

  • At least 7 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required.
  • Experience as lead writer for key components of major US and/or international regulatory submissions in eCTD format required.
  • Experience managing writing activities for a US or international regulatory application (project or people management) preferred.
  • Experience working with eDMS.

Other Skill and Abilities:

  • Highly organized with strong attention to detail, clarity, quality, accuracy, and conciseness.
  • Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace.
  • Must be an experienced, influential, and credible professional who is able to establish and maintain effective and successful working relationships both internally with all Ono Staff, and with external technical and medical experts, in a collaborative and cohesive manner.
  • Able to work collaboratively in a team-oriented environment, taking on responsibility and accountability for assigned programs.
  • Able to balance strategic approach with the needs of an organization requiring hands-on work, while addressing competing priorities that may require, at times, a sense of urgency.
  • Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
  • Understanding of FDA/international regulations and guidelines, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs), and US publishing and technical conformance criteria.
  • Ability to understand Ono guidelines and requirements related to the preparation and production of regulatory documents and submissions.
  • Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
  • Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
  • Knowledge of team dynamics.

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.

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 Senior Medical Writer may have to occasionally 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 30% of the time.

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 Director, Corporate Communications

Position Summary:

To support the recent growth of its U.S. operations, Ono is seeking an experienced corporate communications senior director to support and enhance the company’s reputation by telling a compelling and consistent corporate story and maintaining relationships with key US stakeholders. Working in close collaboration with critical functional leads – including, but not limited to, Marketing, HR, Medical and Legal etc. – this individual will manage both internal and external communications, including media relations. Reporting to Head of Corporate Management, this individual will also be responsible for developing and managing a proactive US media relations strategy in close partnership with corporate communications of headquarters and drawing up and executing corporate branding strategies. The role will work to enhance awareness of and support for our company, pipeline, and science, while maintaining a consistent Ono brand globally. The individual should have a strong understanding of the business, scientific, and media landscape as it pertains to the biopharmaceutical industry, extensive experience in corporate public relations, and the ability to build close relationships cross-functionally and to effectively counsel senior executives. In the course of their work with OPUS, they may liaise with third party companies such as PR or advertising agencies, and so must be well-versed in the US public relations landscape.

Responsibilities and Duties:

  • Develop, execute, and manage all OPUS corporate communications activities. Regularly communicate with the corporate communications team at the headquarters, identify the company’s most pressing issues, and formulate and execute effective strategies in the U.S..
  • Develop overall guidelines such as implementation policies for public relations activities conducted with relevant departments within OPUS.
  • Actively disseminate information to stakeholders, including mass media, physicians, advocacy groups, and others in the US. Regularly evaluate the relevance and success of these public relations activities, relay results to the headquarters, and adjust strategy as needed moving forward.
  • Manage and ensure appropriateness of all media activities performed as part of the OPUS branding strategy.
  • Enhance internal communication by cultivating a culture where OPUS employees can easily communicate and have access to OPUS activities and opportunities.
  • Provide support (e.g., media training) for OPUS management and employees to give talks and presentations both inside and outside the company.
  • Collaborate with third-party organizations, such as advertising or production firms, around OPUS public relations efforts.
  • Lead media monitoring and analyse data to identify trends in the environment, industry, and competitors and regularly communicate insights and learnings to headquarters.
  • Contribute to the development of junior staff members.

Educational Requirements:

  • BA/BS degree in Journalism, Communications, Marketing, or related field. Advanced degree a plus.

Experience:

  • Approximately 10 years of experience in communications, in a PR agency or PR-related department in a healthcare/life sciences company.
  • Ideally having served as a media spokesperson with top-tier national and international media outlets, bringing deep expertise in financial communications, issues management, and healthcare media relations.
  • Stellar communication skills to negotiate with corporate executives, media, the research community, various organizations including patient advocacy, investors, payers, and regulatory authorities.
  • Success pitching articles to the media and building relationships with reporters.
  • Experience in involving in launching new products or the field of hematology.

Other Skill and Abilities:

  • Ability to prioritize, multitask, and lead and execute large projects, including individual execution plans, team composition, and progress management.
  • Ability to work closely with clinical development and marketing teams as well as key internal and external stakeholders beyond corporate communications members.
  • Excellent verbal and written communication skills. Ability to quickly create materials in digital media, such as press releases and websites, capturing the voice of the company.
  • Flexibility in changing situations and ability to respond adeptly to internal and external questions and branding challenges.

Reasoning Ability:

  • Analytical problem-solving skills.
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.

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 domestically and internationally on a reasonably frequent basis, including some weekend travel, and occasionally attend meetings at the Ono Corporate Headquarters in Japan.

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 Director, Strategic Pricing and Access Strategy

Position Summary:

The Senior Director, Strategic Pricing & Access Strategy is responsible for developing innovative pricing and access strategies for ONO Pharma and its brands. The ideal candidate will have experience in evaluating stakeholder business models, understanding policy changes; and designing and managing innovative ways of securing access for our brands. This role will lead the development of pricing strategies for in-line and launch products, monitor and assess government policy changes, related business impact and have an oversight on government price reporting. This position will report to Vice President, Market Access. Responsibilities include but not limited to the key areas outlined below.

Responsibilities and Duties:

  • Responsible for the development of pricing strategies for Ono’s launch and pipeline products.
  • Responsible for tracking and communicating changes in the healthcare landscape, competitive activities, as well as changes in the regulatory environment that impact pricing and access strategies.
  • Develop contracting and reimbursement strategy recommendations across all institutional and provider customer channels, and contribute to development of gross-to-net financial forecasts.
  • Leads market research activities in support of pricing and access strategies to develop innovative and potentially disruptive approaches to working with existing and new models.
  • Lead assessments of institutional and provider practice economics and determine strategy with relevant stakeholders (clinics, GPOs, institutions, 340B entities), including contracting if appropriate.
  • Proactive approach to innovative payment models and/or value-based agreements.
  • Lead evaluations and monitor impacts of reimbursement methodologies across payer channels.
  • Lead assessments of US payer environmental trends and healthcare policy changes to determine implications to pricing strategies.
  • Educate and influence internal stakeholders, in understanding the US pricing environment, market access considerations, and impact of healthcare reform on pricing & amp; reimbursement.
  • Oversees review function for government pricing calculations and submissions, in partnership with finance, legal & external stakeholders.
  • Ensure compliance with all governmental regulations, reporting requirements and state and federal laws.

Educational Requirements:

  • Requires minimum of a Bachelor’s Degree; Advanced degree in Finance, Economics, Health Economics, or a similar discipline is 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:

  • Strong analytical skills and an ability to think strategically about the impact of various pricing approaches that could be employed in a complex ecosystem/marketplace.
  • Ability to work across boundaries and partner with various stakeholders to build consensus and get results.
  • Excellent communication, presentation and time management skills required; must be adaptable, flexible, and able to work well within a team and relate effectively with people at all levels of the organization including Senior Leadership.
  • Able to inspire a matrix team to excel by fostering a climate of energy, excitement, and personal accountability.
  • Proven teamwork and collaboration skills with a demonstrated track record working with cross-functional teams.
  • Ability to analyze data to drive decision-making.
  • Proven ability to think innovatively to solve access barriers.

Business Travel:

  • Ability to travel, estimated 30%.

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 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%.

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] ***

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%

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, Digital / Web Lead

Position Summary:

Serving as a key member of the Ono Pharma USA, Inc. (OPUS), Marketing team, this individual will be report to the brand lead and will be responsible for developing Tirabrutinib omnichannel strategy and tactical execution, including digital and paid media, and integration of NPP efforts with personal promotion efforts utilizing an omnichannel framework and a deep understanding of customer needs across professional and consumer as well as channel expertise. This role requires working collaboratively with cross functional teams and play a critical role in the execution of brand strategy and priorities. The individual must be well-organized, strategic-minded, and detail-oriented with excellent written and verbal communication skills.

Responsibilities and Duties:

  • Lead the tirabrutinib digital marketing strategy and tactical planning and execution.
  • Seek and identify emerging digital technologies that can create innovative delivery of strategic brand imperatives – traditional web, social media, new/emerging technologies, and traditional marketing platforms.
  • Harness internal and external innovation across traditional and non-traditional technologies that align with brand priorities and strategy.
  • Collaborate development and execution of tirabrutinib promotional plan and programs, and ensure their consistency with brand strategy
  • Partner across personal and non-personal promotion to ensure alignment of marketing initiatives and messaging.
  • Identify innovative ways to link our personal promotion channels to our non-personal promotion channels via our internal and external CRM systems. Thus allowing both channels to support our goal of no patient left behind.
  • Manage partner agency relationships, workflow, and related expense budgets – working to identify and execute on identified efficiencies and synergies with agency partners.
  • Partner with Business Operations team and external partners to define success metrics and analyze performance of marketing programs on an ongoing basis.
  • Partner with the Business Operations Team to identify and implement cutting-edge measurement tools that rely on emerging “big data” and “AI” capabilities. Focusing on the bespoke and specific nature of marketing in the Hematology space.
  • Align internal MLR review processes and work with external partners to ensure timely and accurate preparation of digital programs (e.g., CRM, media, websites, mobile, email, social media, SEO/SEM, point-of-care, etc.)

Essential Requirements:

  • Bachelor’s degree.
  • Minimum 5 Years of experience in pharmaceutical and/or healthcare industry with experience in one or more of the following: managed markets, brand marketing, sales, pricing or market research/analytics, strategic planning.
  • Oncology experience is highly preferred.
  • Experience in Digital Marketing, Media Channel Marketing, and Consumer Marketing.
  • Ability to manage complex projects.
  • Demonstrated ability to lead a cross-functional team.

Desirable:

  • Advanced Degree - Masters or MBA.
  • Pharma and/or healthcare industry experience.
  • Solid understanding of the local healthcare system pricing and reimbursement.
  • Knowledge of digital health.
  • Knowledge of the MLR (Medical, Legal, Regulatory) Planning regarding the development and approval of promotional content that enables the delivery of multichannel and omnichannel campaigns.
  • Strategic Project Management, SAFe Agile (Sprint/MVP focused) planning experience, and/or certification
  • Understanding of scientific and/or commercial marketplace respective to biopharmaceutical therapeutic area(s).

Other Skill and Abilities:

  • May be required to work beyond normal business hours, (e.g., teleconference with counterparts of Japan parent company) as business needs dictate.
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Business Travel:

  • This role requires the incumbent to travel domestically up to 20% of time.
  • Must possess a valid driver’s license and have a clean driving record.

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] ***