(Senior) Medical Director*
- Cambridge (Boston)
- Work experience
- Senior, very experienced
- Research, development, teaching
(Senior) Medical Director*
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
The (Senior) Medical Director is recognized within BioNTech as the ‘program lead’ for one or more assets entering clinical development phase. The medical director will have multiple opportunities to lead the design and execution of development strategies, from pre-IND to NDA and will work closely with exceptional preclinical and clinical scientists in implementing these development plans. There is extensive opportunity for interactions with the Company’s senior management, and externally with highly-recognized clinical investigators in the US and throughout the world.
Here, you’ll achieve greatness.
- Provide leadership and coordination with multiple research functions on key clinical efforts
- In collaboration with the Clinical Operations lead, coordinate study activities in the program
- Lead development of the Clinical Strategy/Clinical Development Plan and provide medical oversight into protocol development, data generation, and reporting
- Apply expertise and advise on the execution of clinical partnerships, including developing strategy and performing diligence
- Oversee Phase I-IV clinical development programs to ensure that regulatory requirements and quality standards are met. Strive to maintain or exceed compliance obligations for Good Clinical Practices guidelines and standard company operating procedures
- Act as a company representative in interactions with external scientific leaders and regulatory authorities:
- Search and analyze medical literature, write/review abstracts, manuscripts, etc., for publications and/or presentation at internal/external meetings
- Lead/participate in investigator meetings and advisory committee meetings
- Lead/participate in strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with a clinical development program; Responsibilities may also include post marketing commitments and life cycle management initiatives
- Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol
- Co-lead product safety review committees as appropriate
- Provide consultation on medical subjects to investigators and other company personnel, and apply medical knowledge to guide the safe, ethical, and efficient conduct of trials
What you have to offer.
- MD or equivalent
- Subspecialty training in oncology/hematology; minimum 3 years academic and/or industry experience
- Demonstrated potential or ability to design, initiate, and conduct clinical studies
- Practiced in clinical study design, in academia and/or industry
- Proven ability to analyze and interpret efficacy and safety data relating to oncology
- Able to work across many interfaces (clinical/clinical operations, clinical/project management, clinical/regulatory, clinical/commercial, etc.)
- Demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global matrix team environment
- Strong and effective communication skills (written and verbal); excellent medical/scientific writing skills
- Personal ethical integrity and a commitment to improving the outcomes for patients with malignancies
- Postgraduate training/certification/fellowship in drug development or in a medical discipline
- Experience in regulatory interactions throughout the different phases of development
- Experience and solid understanding of drug developing strategy and process
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & 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 free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email firstname.lastname@example.org.
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you