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London, United Kingdom; Berlin, Germany; Mainz, Germany | full time | Job ID: 6950
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.
Responsibilities:
- They will be responsible to oversee and steer the design and execution of clinical trials of their assigned programs, helping to create the clinical development plan for new compounds, and pave a path towards regulatory approval.
- 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 integrate 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.
- Responsible for supervising/mentoring multiple studies/clinicians. Leads horizontally in the program team members from other functions; drives overall performance of the program team
Qualifications:
- M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology
- Minimum of 10 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.
- Demonstrated leadership experience and several years (>2+ years) line management experience in 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
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. 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 Recruiter.
We are looking forward receiving your application.
