The Safety Science Associate Director will work under the supervision of a Safety Science Group Director and will be responsible for particular aspect(s) of an overall program or a group of products. Applicable tasks are not limited to those described, may vary by product(s) assigned and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management. The Safety Science Associate Director may be accountable for a program or may work with Safety Science Directors in support of programs. In some circumstances, the Safety Science Associate Director may also have the role of Safety Science Leader (SSL) for a product/program. The Safety Science Leader (SSL) is the safety science representative on the Global Development Team (GDT), Lifecycle Team (LCT), Clinical Science Team (CST), Established Products Team (EPT) and/or other related project teams and leads the cross-functional Safety Team. As such, the SSL is accountable for Safety deliverables for the product or program including the development and execution of the long-range safety strategic plans for the molecule, including the design, monitoring, analysis, and reporting of studies and other data sources throughout the product lifecycle. The SSL brings safety expertise to interactions with Health Authorities and Data Monitoring Committees and must have the ability to interact effectively in a multifunctional and multicultural team setting. The Safety Science Associate Director will consult with physicians in Safety Science, as needed, for medical input on safety issues.
Product Development Safety Risk Management:
Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP), 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 (e.g., Integrated Safety Management Plan (ISMP), RMP)
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 (iDMC) or internal monitoring committee (IMC) meetings, as applicable
Prepare and present (or support presentation) of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
Pharmacovigilance (PV) and Risk Management:
Contribute to the ongoing 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 (SDP) and the signal detection and assessment activities
As assigned, support the Safety Science Leader or Director/Group Head, Safety Science or be responsible for the development of the RMP/ISMP or Risk Evaluation and Mitigation Strategies (REMS) for submission to regulatory health authorities (HA)
Prepare and review periodic aggregate safety reports (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.
Will work in partnership with CSSD team members to meet Safety Science deliverables
Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures and other guidelines.
Education, Skills and Experience
Bachelor’s Degree in life sciences required; Advanced Clinical/Science Degree preferred (e.g., PharmD, PhD, MSN, MPH, DDS, DVM, etc.)
2 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
Experience in the principles and techniques of data analysis, interpretation and clinical relevance
Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle
Strong orientation towards cross-functional teamwork
Effectively work with remote partners on a global team
Excellent written and verbal English communication skills
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.