Director, Medical Safety
Open for hire at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID: 5187
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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Director, Medical Safety
The Director of Medical Safety (Scientist) will lead the medical strategy and clinical risk management planning of multiple complex products within the Oncology Therapeutic Portfolios (Infectious Diseases Portfolio). Reporting to the Head of Medical Safety, you will work collaboratively with the Safety Strategy Lead (SSL), Safety Physician (SP), Safety Managers (SM), and other Scientists and Physicians with leadership in project teams and across matrix organization, including counterparts within Core Teams, Clinical Program Teams, Global Regulatory Affairs, and other cross-functional delivery groups.
The role may span multiple oncology assets and the entire life cycle of drug development and peri-/post-submission, from the early to late phases of development, and include delivery through one or more in-house, outsourced, and alliance delivery models. This role is highly visible in MSPV and in the Global Development Organization (GDO).
This is an exciting time to assume a strategic role in MSPV and help translate science into survival by shaping the culture of patient safety for the wider BioNTech organization. BioNTech’s pipeline, which includes mRNA, CAR-T, cancer vaccines, and other breakthrough technologies across different drug classes poised to revolutionize medicine, provides an intellectual challenge to the safety teams requiring a broad portfolio and scientific management approach to projects.
Key qualities include demonstrated ability to provide safety scientific input and leadership for programs/safety management teams through strategic and operational safety expertise and excellence in stakeholder management. This role requires competent strategic thinking, solution-finding, agility, adaptability, comfort with grey areas, impeccable communication skills, tact, and the ability to lead and drive change.
Required behaviors include effectiveness at building networks of partners and stakeholders, continuous learning and curiosity, and the ability to provide clarity, teach, lead, and inspire others. A track record of effective peer communication and shared learning is critical.
Key Responsibilities:
- Lead one or more Safety Management Team(s) and support the conduct of internal/independent data monitoring review boards.
- Lead the safety surveillance strategy and the presentation of sophisticated safety topics at cross-functional teams and internal governance committees.
- Provide strategic input and author periodic safety reports and regulatory health authority (HA) submissions & responses.
- Partner with the SSL and other MSPV members to lead the safety strategy for regulatory submissions of new products, formulations, or indications (NDA/BLA, MAA).
- Participate in due diligence activities, negotiating the PV agreements and safety components of contracts with vendors.
- Lead alliance collaboration efforts and represent MSPV at the cross-company committees.
- Provide training and mentorship to other MSPV Scientists and junior safety physicians.
Main Requirements:
- BS/MS in sciences/pharmacy/nursing or related field; or any equivalent degree; A relevant postgraduate qualification (e.g. PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post-graduate health professional qualifications) would be advantageous
- 7+ years of relevant experience
- Extensive Patient Safety and/or Pharmacovigilance/Clinical/Drug Development experience in leading safety scientific activities across the following areas:
- Clinical development – setting up a program-level safety strategy, including proactive risk identification & mitigation planning for Early and/or Late-stage clinical products
- Signal detection & Evaluation in Clinical & Post-Marketing settings
- Preparation & Authoring of Periodic Safety Reports & Risk Management Plans
- Preparation & Authoring of Health Authority Responses, including support of safety crisis-type scenarios
- MAA/BLA submissions - preparation and authoring of safety sections of the Common Technical Document
- Planning, arrangement, and execution of the post-marketing commitment
- Infectious diseases: practical knowledge of vaccine trials in the population and/or clinical trials in low-grade infrastructure geographies
- Experience in data analysis and reporting of results from interventional clinical trials
- Governance board interactions and communication across a range of activities
- Advanced knowledge of PV regulations
- Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues
- Ability to work effectively in an advanced matrix structure
- Proficient English verbal and written communication skills
Benefits for you
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
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Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
Have we kindled your pioneering spirit?
This vacancy is to be hired at one of the following locations – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. Apply now for your preferred job and location through our careers site.
*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!