(Senior-) Medical Director, Clinical Development

(Senior-) Medical Director, Clinical Development

Open for hire at one of the following locations - Cambridge Erie Street, London, Mainz Goldgrube. - Job ID: 6963

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.

Key Responsibilities:

1. Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.
2. Collaborate with the VP to operationalize clinical strategies for assigned portfolios.
3. Lead program strategy, development plans, and submission processes.
4. Serve as Program Lead, guiding core teams and aligning objectives across functions.
5. Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.
6. Work closely with Clinical Operations to ensure patient-centric drug development.
7. Drive innovation in trial design, leveraging digital endpoints and real-world evidence.
8. Prepare key clinical documents (e.g., Investigator's Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.
9. Manage relationships with external stakeholders and represent the team in governance meetings.

What you have to offer:

1. M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology.
2. Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission.
3. Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
4. Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage.
5. Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
6. 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 are determined by the specific role, location of employment, and also the selected candidate's qualifications and experience.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations - Cambridge Erie Street, London, Mainz Goldgrube. Apply now for your preferred job and location through our careers site.