Medical Director*, Infectious Diseases
Become a member of the BioNTech Family!
Medical Director, Infectious Diseases
- He/She will be responsible and hands-on involved in design and execution of clinical trials of his/ her assigned programs, driving the clinical development plan for new compounds and/ or indications.
- Generates and reviews high quality clinical regulatory documents Investigational New Drug (IND) Applications, Briefing Documents, Investigational Brochures, Investigational Product Labeling, IND annual reports, Investigational Medicinal Product Dossiers (IMPD), common technical documents as the basis for new drug applications (NDA) and Marketing Authorization Applications, other EMA/CHMP regulatory documents and scientific white papers.
- Drives the operational planning, content, execution and delivery for our programs and studies. Provides critical input to the design of clinical trials and manage the development of clinical trial protocols, amendments, informed consents and overseeing data review activities and communicating with investigator / sites where appropriate.
- The Director Clinical Development will work closely with Program Clinical Development Lead, and represent BioNTech in collaboration projects with industry partners as appropriate. He/ she also contributes to interactions with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. He/ she will support the VP Clinical in the development of presentations to senior management and decision makers.
- Assumes Global Clinical Development Study Lead responsibilities; working hand-in-hand with the Program Clinical Lead to develop and implement CDP and design clinical trials
What you have to offer.
- M.D. and/or M.D. Ph.D with strong scientific and clinical background in Infectious diseases.
- Experience within Infectious diseases in the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late-stage development in Phase III and NDA/BLA submission.
- Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
- Experienced in global health authority interactions (EMA, FDA, CDE). Having participated or led a drug development program to successful registration is an advantage.
- Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
- Demonstrated leadership experience matrix management experience in a global organization. Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority.
- High level of comfort and demonstrated successes working in a matrix environment (global and cross-functional), including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners.
- A genuine interest and understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
- Provides subject matter expertise and has a genuine interest to mentor and develop others.
- Proficiency in English (written and spoken)
Benefits for you.
- Medical, Dental, and Vision Insurance
- Life, AD&D, STD, and LTD Insurance
- HRA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
- And more!
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6856 #LI-DCA (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you