Senior Director, Clinical Development

Open for hire at one of the following locations

• Cambridge Erie Street.

• Job ID: 7391

Join our team of pioneers!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Senior Director, Clinical Development

The Senior Director of Clinical Development will work with the VP of Clinical Development to steer clinical strategies and operationalize them for the assigned programs. They will lead the strategic direction of assigned programs. They will 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, medical knowledge, patient safety and data integrity. The Senior Director of Clinical Development will be responsible for overseeing and steering the design and execution of clinical trials for his/ her assigned programs, helping to create the clinical development plan for new compounds, and paving a path toward regulatory approval. The Senior Director of 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 of Clinical development by making strategic proposals on our platforms, including 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 developing new treatments to address unmet needs in Infectious Diseases are critical for success.

Responsibilities:

• 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 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 the 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 the Clinical Operations team for patient-centric drug development, ensuring the 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, and 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.

• In programs with multiple studies, matrix line management and mentoring of clinicians responsible for those studies. Delegates activities appropriately 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.

• Supervise/mentor multiple studies/clinicians. Leads horizontally in the program team members from other functions; drives overall performance of the program team

Qualifications

• Minimum of 10 years of experience within Immuno-Oncology, Oncology, and/or Infectious diseases 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, such as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling, and biostatistics. Complemented with several years of experience in 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 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 (>4 years) of line management experience in a global matrix organization. Ability to lead horizontally and drive execution of work plans 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

Benefits for you

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.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.

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.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations

• Cambridge Erie Street. Apply now for your preferred job and location through our careers site.

• BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match!