The Group Medical Director, Safety Science leads and directs a group of safety science professionals within the assigned therapeutic area who together are accountable for all aspects of Safety within a therapeutic area or a disease area and provide strategic direction and standardization of performance across their teams. The Group Medical Director, Safety Science directs PDS’ scientific analysis including medical evaluation, signal detection, signal management and risk management using the appropriate tools and databases to characterize and manage risks. The Group Medical Director, Safety Science will ensure the incorporation of Benefit-Risk concepts in the disease area strategy and product plans and their use throughout the development and commercial lifecycle of products assigned to the group to ensure their longevity. The Group Director, Safety Science provides leadership, management, mentoring, and professional development for their team in the disease area.
Ensure proactive safety surveillance and monitoring activities across the disease or therapeutic area (DA) portfolio and ensure the development and execution of appropriate strategies & action plans to prevent & mitigate risks.
Coordinate all PDS product-specific activities within the specific safety science DA including signal detection, medical evaluation, risk management, benefit/risk evaluation and communication, and epidemiology as appropriate, for all products in the DA through their development and product lifecycles.
Under the guidance of the Therapeutic Areas Head, Safety Science and where appropriate ensures the incorporation of Benefit-Risk concepts and their use throughout the development and commercial lifecycle to ensure the safety and longevity of all products in their DA.
Build and leverage PDS’ influence with internal stakeholders to create value for Roche.
Act as final functional reviewer for key documents including protocols, clinical study reports, Investigator's Brochure (IB), integrated summary of safety, summary of clinical safety and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
Is a standing member of the Therapeutic Area Leadership Team
Develops risk assessment or risk mitigation tactics that are of interest across various product teams (e.g. guided questionnaire for hepatic issues).
Deputizes for the Therapeutic Areas Head, Safety Science in maintaining managerial oversight of issues and outputs from the DA Safety Teams; address or elevate issues to the Therapeutic Areas Head, Safety Science as needed.
Build and leverage the company’s and PDS’ influence with internal and external entities to create value for Roche.
Collaborate and partner successfully with other functions to create joint plans and to provide thought leadership in the areas of risk management and signal detection by elevating new and experimental analytical techniques.
Liaise within the company to advise partners on the use and benefits of safety risk management activities.
Represent PDS at DRC and other review and/or governance bodies and provide thought leadership
Assist Therapeutic Area Head with budget oversight as needed and and act as cost center manager when appropriate
People Development and Management
Direct and manage a team of safety science professionals and ensure their performance is proactively managed and they are coached, trained and developed in order to maximize their contribution.
Provide leadership to his/her reports and other members of the Safety Sciences department.
Ensure that staff communication and employee relations are managed proactively to maximize the wellbeing of the employees.
Drive alignment across various safety science DAs as appropriate.
Nurture the collaboration between staff within the DA and other DA teams.
Contribute to cross alignment across various safety science DAs as appropriate.
Identify future needs for resource at the site and identify, recruit, train and develop appropriate talent
Additional Physician Responsibilities
All Safety Science Group Medical Directors will provide medical expertise to Product Development Safety (PDS) Science teams as needed and will provide medical oversight to non-physicians in Safety Science. These additional responsibilities may include:
Medical interpretation of emerging clinical safety data for signal detection and signal evaluation purposes, and to determine the medical significance of any findings
Determining the causal relationship of events for Individual Case Safety Reports (ICSRs) when the task resides in PDS
Defining the safety question or issue requiring medical safety assessment
Reviewing and approving for drug safety reports, PBRER/PSUR and other aggregate reports
Determining medical impact of nonclinical safety findings
Reviewing and approving (if needed) clinical protocols to ensure medical appropriateness of safety relevant sections such as inclusion/exclusion criteria, safety monitoring and management, and schedule of assessments.
Providing medical interpretation of whether/how risks impact the overall risk-benefit balance
Who You Are
Education, Skills and Experience
Completed MD degree and post-graduate training with 2 or more years of clinical or academic experience. Specialty training and board certification or equivalent (current or past) strongly preferred.
5 or more years of relevant pharmaceutical or related experience (e.g. drug safety, clinical development, medical affairs, translational research, clinical pharmacology, or toxicology)
3 or more years management experience
Demonstrated success mentoring others and modeling leadership behaviors
Experience leading global cross-functional teams (eg, GDT) desired
Prior experience in Clinical Development or Medical Affairs preferred
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 verbal and written English communication skills.
Well versed in utilizing a variety of influencing techniques to quickly build respect and gain the confidence of others.
Demonstrated experience proactively executing strategy across Therapeutic Area
Experience publishing in a refereed journal desired
Demonstrated success mentoring others and modeling leadership behaviors
Strong negotiation skills
Ability to manage resources and budget, across multiple locations and negotiate contracts
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.
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