New Jersey, US; Cambridge, US; Gaithersburg, US | full time | Job ID: 8810

The Senior Director Clinical Development will work hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization for the assigned programs. He/ She will lead the strategic direction of assigned programs and will be responsible to oversee and provide guidance for the design and execution of clinical trials from early to late-stage development through regulatory approval, leading a matrix team. This includes thorough data interpretation based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity.

This position can be on-site, hybrid, or remote.

Responsibilities:

• Responsible to oversee and steer the design and execution of clinical trials of his/ her assigned programs, helping to create the clinical development plan for new compounds, and pave a path towards regulatory approval.
• The Senior Director Clinical Development will work closely and represent BioNTech in collaboration projects with industry partners and also contribute to interactions with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. He/ she will interact closely with the VP Clinical development by making strategic proposals on our platforms incl. overall approaches & investments.
• A genuine interest and understanding of the science supporting the pipeline, an ability to lead and work collaboratively in a multidisciplinary team setting, and a commitment to develop new treatments to address unmet needs in Oncology and/or Immuno-Oncology

• Works closely 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 expert and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans.
• Supervises ongoing medical data review and ensures medical queries of running studies are resolved
• 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.

Qualifications

Education

• M.D. with strong scientific and clinical background in Immuno-Oncology and/or Oncology.

Experience

• Minimum of 10 years of experience within oncology drug development in the biotech/pharmaceutical and/or the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late-stage development in Phase III and regulatory 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 in a global matrix 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

Expected Pay Range: $323,000/year to $395,000/year + 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
• 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.

Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.

Apply now - We look forward to your application!

Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US 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.