Senior Director​/Director Clinical Development

Senior Director/Director Clinical Development

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New Jersey, US;
Cambridge, US;
Gaithersburg, US | full time | Job

The (Senior) Director, Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.

• Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.
• Collaborate with the VP to operationalize clinical strategies for assigned portfolios.
• Lead program strategy, development plans, and submission processes.
• Serve as Program Lead, guiding core teams and aligning objectives across functions.
• Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.
• Work closely with Clinical Operations to ensure patient-centric drug development.
• Drive innovation in trial design, leveraging digital endpoints and real‑world evidence.
• Prepare key clinical documents (e.g., Investigator’s Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.
• Manage relationships with external stakeholders and represent the team in governance meetings.

• M.D. with strong scientific and clinical background in Immuno‑Oncology, Oncology.
• Several years of experience within Immuno‑Oncology, Oncology at the biotech/pharmaceutical and academic setting, including leading clinical development programs from exploratory Phase I/II through late‑stage development in Phase III and NDA submission.
• Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, 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, MHRA, 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.
• Ability to apply situational management style to both mentor and accelerate capabilities of its reports.

Expected Pay Range: $267,000/year to $397,000/year + benefits, annual bonus & equity (bonus and equity are variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities, education, experience, knowledge, skills, and abilities.

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre‑tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitter stream:
  Virtual Tutoring & Childcare Membership
• Paid Time Off:
  Vacation, Sick, Bereavement, Holidays (including Floating) & Year‑End U.S. Shutdown
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

BioNTech US is committed to employee wellbeing and offers best‑in‑class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position‑Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space,…