Position Summary:

• Direct oversite and coordination of the current Good Manufacturing Practices (cGMP) function and assist management in identifying strategic direction, policy development.
• Promote and assess compliance with regulations by Ono and vendors working on behalf of Ono.
• Provide resources for development and commercial groups for consultation and interpretation of cGMP regulations, guidelines and ONO’s standards.
• Direct the cGMP SOP preparation and maintenance within the business unit and harmonization of procedures.
• Liaise with Ono Headquarters and Ono UK, as needed.

Responsibilities and Duties:

• Create and maintain an up-to-date audit plan.
• Plan, conduct and coordinate cGMP audits, as necessary. This may include preparation, conduct, report, follow-up and audit closure.
• Interface with senior management and transnational management regarding cGMP quality and compliance issues, as necessary.
• Provide guidance and oversight of direct reporters and CMOs hired by ONO.
• Review and approve batch records, packaging and labeling of investigational and commercial product.
• Develop, implement and oversee processes and procedures covering complaints, recalls, event, deviations, root cause and risk analysis, change control, CAPA, training, issue escalation and management review, annual product review, QMS review, etc.
• Lead cGMP training for OPUS personnel. Give more detailed cGMP/Audit training to QA personnel in OPUS, as necessary.

Educational Requirements:

• Master/Doctorate degree with at least seven years of related pharmaceutical or biotechnology experience or bachelor’s degree with at least 7-9 years related pharmaceutical experience, or equivalent.

Experience:

• Solid experience in development and implementation of Quality Management Systems (QMS) for cGMP commercial and clinical.
• Extensive use of computer processing and database.
• Knowledge and experience in implementation of the requirements of the Drug Supply Chain Security Act (DSCSA).
• Extensive experience in cGMP and 21 CFR Parts 11, 312 and 314 and global cGMP regulations.

Other Skill and Abilities:

• Demonstrated leadership skills and the ability to develop staff members.
• Project and regulatory management abilities.
• Excellent written and oral communications.
• Sound judgement and reasoning skills to define problems, collect and analyze data.
• Strong interpersonal and negotiation skills and ability to positively influence and guide others.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team-oriented skills.

Language Skills:

• Ability to respond to internal and external inquiries.
• Ability to write clear and compliant cGMP procedures.
• Ability to effectively present information to internal and external groups.
• Ability to apply lessons learned into process improvement.

Mathematical Ability:

• Ability to apply mathematical concepts to cGMP operations.

Reasoning Ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret technical instructions, analyse gaps and suggest process improvement.

Systems/Computer Skills:

• Knowledge of databases, spreadsheets and software.
• Proficient in Microsoft Office.
• Thorough knowledge and experience in the application of 21 CFR Part 11 requirements e.g. MasterConrol and Track Wise.

Other:

• As part of a global company may need to be available for early and later conference meetings.
• Ability to read printed materials and written information on a computer screen is required.

Business Travel:

• Business Travel: Minimal.

This role requires travel (domestic and/or international) based upon business needs. Travel should not be higher than 25% of the time.

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

Position Summary:

Reporting to VP Drug Safety and pharmacovigilance of Ono Pharma USA, INC. (OPUS). The Senior Director, PV and Drug Safety is responsible for the effective delivery of and continued evolution of PV activities for clinical trials and clinical development products managed by OPUS in order to meet regulatory requirements, company objectives and quality standards. From a Drug Safety perspective, the incumbent is responsible for evaluating the risk benefit of ONO compounds in development through pre and post-marketing. Promote global PV activities liaising with Pharmacovigilance (PV) department of Ono corporate headquarter.

Responsibilities and Duties:

• The incumbent will take responsibility may serve as a Safety Leader for safety matters with responsibility for PV activities at OPUS for all clinical trials conducted by OPUS.
• The incumbent will contribute to and support the operational conduct of any clinical trial(s) and general management activities of the Clinical Development Division at OPUS.
• Ensure that all applicable PV regulatory requirements in the appropriate countries are followed.
• Manage the safety profiles of clinical development and post-marketing products, including signal detection.
• Responsible for risk management activities for clinical development and post-marketing products (e.g. risk identification, risk evaluation and development of appropriate risk management plans and documentation).
• For US studies, assume responsibility as the responsible person for FDA Adverse Event Reporting System (FAERS) at OPUS for clinical trials.
• Utilizes, updates and maintains ONO’s global PV data system and collaborates with leaders and other members of ONO global pharmacovigilance organizations, such as Ono Pharma UK and Ono corporate headquarters, to ensure consistency across the ONO organization.
• Interpret safety data to educate and support project teams in preparation for external meetings with Key Opinion Leaders, Investigator Meetings, Competent Authority(s), Ethics Committees, etc.
• Contributing to the development of the project strategy (including commercial/feasibility aspects) and the clinical development plan.
• Act as the medical expert with respect to PV and safety topics, advising and supporting appropriate internal and external groups where necessary.
• Manage the process for compiling and medical review of ICSRs and aggregate reports.
• Provide expertise and support for urgent safety reviews for products and development compounds.
• Lead and/or contribute to key project study documentation, including but not limited to: IB, protocol, SAP, DSUR, IMPD, DRMP, SRC Charter and clinical study report, etc.
• Comply with OPUS Quality Management System and working practices, Pharmacovigilance regulations and guidelines, GxPs, as applicable. Ensure required training records are maintained up to date.
• Establish the study start up activities and ensure that the PV processes and procedures documented in Standard Operating Procedures, guidelines and User Manuals are effectively implemented and regularly reviewed and communicated through targeted training activities to ensure continued compliance.
• Contribute to development and maintenance of company policies, SOPs and OPUS documents.
• May be required to perform other duties, as assigned.

Educational Requirements:

• This position requires Medical Degree (M.D.)

Experience:

• Possess at least twelve years of in-depth pharmacovigilance or drug safety knowledge and relevant clinical development and post-marketing experience within the pharmaceutical, CRO, or biotechnology industry.
• Oncology knowledge and experience is required; additional knowledge and experience in immunology and/or neurology are/is preferred.
• Demonstrated success leading PV in a global environment as a Safety Leader, with a knowledge of drug safety regulatory compliance.
• Proven experience in all clinical aspects of a clinical trial with a strong knowledge of SOPs and accepted practices. Clear understanding of the work performed by other Clinical Development and post-marketing functions and how they interact.
• Understanding of the principles of ICH Guidelines, GCP, GMP and global regulatory requirements.
• Detailed current knowledge and experience of regulations and guidelines on global Good Pharmacovigilance Practices.

Other Skill and Abilities:

• Highly organized with strong attention to detail, clarity, 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.

Language Skills:

• 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 KOLs, investigators, representatives of a regulatory agency, patients, and peer group members.

Mathematical Ability:

• Mathematical capabilities associated with necessary big data analytics.

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:

• Experience with data visualization systems and safety systems (i.e. ARGUS, ARIS-g) are required.
• 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 and 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 20% 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] ***