Senior Director/Director Clinical Development
New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany | full time | Job ID: 9682
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.
Key Responsibilities:
- 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.
What you have to offer.
- 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 the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies 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, 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, 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 $397000/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
Your Benefits:
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. Benefits include but are not limited to:
- 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
- Sitterstream: 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
…and more! More details to be shared.
Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.
Apply now - We look forward to your application!
Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany location and simply send us your documents using our online form.
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.