Senior Director, CTSM Individualized IMP Management (Cell & Gene Therapies)
Open for hire at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, Gaithersburg, London. - Job ID: 7232
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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, CTSM Individualized IMP Management (Cell & Gene Therapies)
Responsibilities
This role aims to define and lead initiatives for all Global Clinical Trial Supply Management activities in the Cell & Gene Portfolio in global R&D Programs and to support the development of future commercial launches.
- Grows the Global CTSM Cell & Gene IMP Management business and delivers the desired performance in the right quality and quantity within the set timelines while meeting cost targets and ensuring patient safety.
- Accountable for GxP-compliant execution of assigned clinical Cell & Gene portfolio and building structures as a foundation to support the development of future commercial launches
- Translates Cell & Gene portfolio strategy into platform/trial requirements and ensures the requirements are followed
- Provides perspective on CTSM feasibility into Cell & Gene platform/portfolio core team and/or other strategic decision-making bodies
- Accountable for the definition of performance objectives and performance management for CTSM Cell & Gene IMPM function and other dedicated subfunctions needed in the field of individualized therapies (e.g., Patient Operations Hub)
Qualifications
Education
- Relevant completed university education in Pharmacy, Chemistry, Biotechnology, Biochemistry, or related discipline
- Broad and/or in-depth and special task-specific expertise and skills (doctorate, if applicable)
Experience
- Relevant professional experience (usually 10+ years) in Clinical Trial Supply Management for Cell & Gene Therapies in the Pharmaceutical or Biotech industry setting
- Proven track record in developing platform/portfolio strategy for global clinical trials for Cell & Gene therapies and in supporting the development of the future commercial launch
- Proven track record of supply chain and Cell & Gene study drug logistics, knowledge of the associated special requirements such as CoI/CoC management, demand- and capacity planning etc.
- Proven track record of managing multiple individualized trial platforms and portfolios
- Very sound knowledge and documented experience in relevant legislation and international GMP, GDP, and GCP guidelines
- Profound understanding of electronic systems supporting Clinical Trial Supply Management (e.g. IRT systems, specialized software for use in the field of individualized therapies in clinical and commercial settings) and standard office software proficiency (e.g., MS Office)
- Extensive knowledge of budget and performance management in IMP
- Excellence in Change and Project Management Skills
- Good understanding of Quality Management Systems- Experience in the compilation and coordination of regulatory documents
- Business-professional English language skills; German would be a plus
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.
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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 Goldgrube, 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!