(Senior) Medical Director*, Clinical Development
- Works hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization of portfolios and platforms.
- Owns the strategy formulation and operational planning, content, execution and delivery for assigned programs and will be a key driver of the integrated development, submission and publication plan.
- Assumes Program Lead responsibilities in the assigned programs, in liaison with the responsible program manager. Leads the program core team.
- Creates and translates Target Product Profile into clinical strategy.
- As Program Lead, articulates targets of TPP and CDP to other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) and drives alignment on objectives and expected outcomes
- Responsible for study medical/ safety aspects and risk-benefit assessments supported by the study clinical scientist and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans.
- Supervises ongoing medical data review
- Ensures at the program level, that the clinical development team works hand-in-hand with Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations
- Takes ownership together with partner functions in Development on the acceleration of program and trial design and innovation for the patient (e.g. digital endpoints, synthetic control arms, RWE/ HEOR, PRO, Medical Affairs)
- Owns and ensures preparation for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
- Oversees Clinical Study Report (CSR) medical content meets high quality expectations on medical standards, provides respective guidance to other members of the clinical development team
- Establishes, leads, and manages relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities).
- Represents the team to decision/governance meetings, senior management, or advisory boards as applicable.
- In programs with multiple studies, assumes matrix line management and mentoring of clinicians responsible for those studies. Delegates activities as appropriate and communicates overarching objectives of TPP and CDP, to ensure team alignment. Actively contributes to recruiting, onboarding and continuous capability building of the program clinical development team.
- Responsible for supervising/mentoring multiple studies/clinicians. Leads horizontally in the program team members from other functions; drives overall performance of the program team
Knowledge, Skills & Abilities
- M.D. and/or M.D. Ph.D with strong scientific and clinical background in Immuno-Oncology, Oncology or Infectious diseases. Board certification in Oncology/Hematology or Infectious Diseases preferred
- Minimum of 10 years of experience within Immuno-Oncology, Oncology and/or Infectious diseases at 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 and several years (>4 years) 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.
- Ability to apply situational management style to both mentor and accelerate capabilities of its reports
- Ability to strategize and lead a goal oriented clinical development team.
- 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)
What we offer
- 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 free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
- And more!
To Apply, EEO and BioNTech Websites
*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!
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