Senior Director Clinical Development Late-Stage Oncology (m/w/d)

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:

• Oversee and steer the design and execution of clinical trials of assigned programs, helping to create the clinical development plan for new compounds, and pave a path towards regulatory approval.
• Work closely and represent BioNTech in collaboration projects with industry partners and contribute to interactions with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities.
• Lead and work collaboratively in a multidisciplinary team setting, and commit to developing new treatments to address unmet needs in Oncology and/or Immuno-Oncology.
• Steer clinical strategies and their operationalization of portfolios and platforms in collaboration with the VP of Clinical Development.
• Own strategy formulation and operational planning, content, execution, and delivery for assigned programs, driving the integrated development, submission and publication plan.
• Assume Program Lead responsibilities in assigned programs, liaising with the responsible program manager and leading the program core team.
• Create and translate Target Product Profile into clinical strategy.
• Articulate targets of TPP and CDP to other development functions and drive alignment on objectives and expected outcomes.
• Responsible for study medical/safety aspects and risk-benefit assessments supported by the study clinical expert and Pharmacovigilance.
• Supervise ongoing medical data review and ensure medical queries of running studies are resolved.
• Ensure that the clinical development team works hand-in-hand with Clinical Operations for patient-centric drug development.
• Own and ensure preparation for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, and responses to regulatory authorities.
• Oversee Clinical Study Report (CSR) medical content to meet high quality expectations on medical standards.
• Establish, lead, and manage relationships with key external stakeholders.
• Represent the team to decision/governance meetings, senior management, or advisory boards as applicable.
• Assume matrix line management and mentoring of clinicians responsible for studies, ensuring team alignment.

Qualifications:

• M.D. with strong scientific and clinical background in Immuno-Oncology and/or Oncology.
• Minimum of 10 years of experience within oncology drug development in the biotech/pharmaceutical and/or academic setting, including leading clinical development programs from exploratory Phase I/II through late-stage development in Phase III and regulatory submission.
• Thorough understanding of clinical and scientific methods used in clinical development studies.
• Experienced in global health authority interactions (EMA, FDA, CDE) and leading a drug development program to successful registration is an advantage.
• Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data.
• Demonstrated leadership experience in a global matrix organization.
• Ability to lead horizontally and drive execution of work plans in collaboration with other functions.
• Ability to apply situational management style to mentor and accelerate capabilities of reports.

Apply now - We look forward to your application! Apply to our London, United Kingdom; Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).