Director, Drug Safety

In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.  

Overall Description:

The Director or Senior Director (Drug Safety) serves as the safety expert accountable for the global safety strategy and overall safety profile for the company products throughout their life-cycle. This includes leading all safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with other functions in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Job Duties and Responsibilities:

Responsibilities may include, but are not limited to:

• Develop timely and scientifically sound clinical safety portions of a Product Development Plan, develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
• Contribute to development the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans
• Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
• Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician.
• Accountable for signal detection, evaluation and decision-making across the lifecycle of the product.
• Participate in and provide input for Drug Monitoring Committees or internal monitoring committee meetings, as applicable
• Prepare and present (or support presentation) of important safety issues to internal and external review and governance committees as needed.
• Contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
• Contribute to the ongoing Pharmacovigilance (PV) and Risk Management planning for designated products by preparation of the safety surveillance strategy
• Contributes to the development and oversight of the signal detection plan and the signal detection and assessment activities
• Prepare and review periodic aggregate safety reports (IND Annual Report, DSUR, Periodic Benefit Risk Evaluation Report/PBRER, Periodic Safety Update Report/PSUR, EU renewal and other Safety Reports) and benefit-risk assessments
• Support the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB
• Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (product quality) or in response to HA requests
• May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.
• Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures and other guidelines.
• Contribute and/or lead the development of the safety components of the Target Product Profile (TPP), key claims and other lifecycle strategic planning documents. Responsible for the safety components and co-responsibility for the benefit/risk components together with the Clinical representative
• Develop and maintain comprehensive product safety strategy
• Contribute to the CDP throughout the exploratory and confirmatory phase together with the Clinical representative in order to optimize the benefit/risk profile
• Accountable for the safety components of study reports, aggregate reports and high-level regulatory documents
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues. Lead development of the safety surveillance strategy, identify potential clinical safety issues and recommend appropriate safety monitoring measures
• Enable/facilitate the transition of appropriate drug candidates from exploratory to confirmatory development for all aspects pertinent to safety.
• This position will report to Clinical Development

Qualifications: 

• Requires a minimum of 3 years of experience at a pharmaceutical, CRO or biotechnology company – level will be determined and commensurate with experience
• MD or DO required. Experience in oncology or immunotherapy trials, and early phase clinical trials highly desirable
• Experience in the principles and techniques of data analysis, interpretation and clinical relevance from a drug safety perspective
• Understanding of GCP and regulated processes and end-to-end clinical trial lifecycle
• Ability to think strategically and tactically with an interest in applied clinical research
• Ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize

Excellent oral and written communication skills