(Senior-) Director* Clinical Development

BioNTech AG

Mainz

EUR 80.000 - 100.000

Jobbeschreibung

Become a member of the BioNTech Family!

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

We are looking for you to join us as (Senior-) Medical Director to help drive our cutting-edge oncology pipeline. In this role you are working closely with our Chief Medical Officer and her leadership team and are truly at the heart of the BioNTech story. We can fill more than one role with different focus areas and are looking for candidates that bring in-depth experience in either of the following areas:

Immuno-Oncology
Antibody Drug Conjugates
Cell Therapy
Individualized Cancer Vaccines

In either area we are looking for candidates who have consistent end-to-end experience with clinical trials. These roles require an absolute team player that brings an extraordinary degree of flexibility and accountability to thrive in our fast-paced Pioneer culture.

Your primary responsibilities are:

Work hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization of portfolios and platforms.
Own 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.
Create and translate Target Product Profile into clinical strategy.
Assume Program Lead responsibilities in the assigned programs, in liaison with the responsible program manager, and in that role, articulate targets of TPP and CDP to other Development functions (e.g., Regulatory, Biostatistics, etc.) and drive alignment on objectives and expected outcomes. Lead the program core team.
Responsible for study medical/ safety aspects and risk-benefit assessments supported by the study clinical scientist and Pharmacovigilance, collaborating closely with the Medical Safety and Pharmacovigilance team on development of Risk Management Plans.
Supervise ongoing medical data review.
Ensure at the program level, that the Clinical Development team works hand-in-hand with the Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations.
Take 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).
Own and ensure 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.
Oversee Clinical Study Report (CSR) medical content meets high quality expectations on medical standards, provides respective guidance to other members of the Clinical Development team.
Establish, lead, and manage relationships with key external stakeholders (industry partners, key opinion leaders, health authorities).
Represent the team to decision/governance meetings, senior management, or advisory boards as applicable.
In programs with multiple studies, assume matrix line management and mentoring of clinicians responsible for those studies. Actively contribute to recruiting, onboarding and continuous capability building of the program clinical development team.

What you have to offer.

M.D. and/or M.D. Ph.D with strong scientific and clinical background in Immuno-Oncology or Oncology.
Minimum of 10 years of experience within either Immuno-Oncology, ADCs, Cell Therapy or Individualized Cancer Vaccines 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/BLA submission.
Extensive expertise in clinical development studies in pharmaceutical / biotech companies, including novel study design, companion diagnostics, clinical pharmacology, translational modeling, biostatistics, and Phase 3 trial design, with significant experience in dossier preparation and submission.
The ideal candidate has been consistently involved in clinical trials from beginning to end.
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 and several years matrix management experience in a global organization. Ability to lead horizontally and drive execution of workplans in collaboration with other functions, without having formal line management authority.
High level of comfort and demonstrated successes working in a matrix environment (global and cross-functional), including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners.
A genuine interest and understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
Proficiency in English (written and spoken)

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 –Mainz K1, Cambridge Erie Street, Gaithersburg, London. 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!