Director* Clinical Development
- Senior, very experienced
- Medicine, Pharmacy, Laboratory
- Research, development, teaching
Become a member of the BioNTech Family!
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.
Director* Clinical Development
- Works hand-in-hand with the VP of Clinical Development to steer clinical strategies and their operationalization in programs and trials.
- Drives the operational planning, content, execution and delivery for our programs and studies. Will manage day-to-day clinical activities for our clinical studies incl management of protocol amendments, overseeing data review activities and communicating with investigator / sites where appropriate.
- Assumes Program Lead responsibilities when assigned as clinical lead for a program, in liaison with the responsible program manager. Leads the program core team.
- 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. Drives translation of Target Product Profile into clinical strategy.
- Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives and drives alignment on objectives and expected outcomes
- Responsible for trial medical/ safety aspects and risk-benefit assessments supported by the Clinical Trial Scientists and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans.
- Collaborates and gives guidance for the Clinical Trial Scientists, and works with them on day-to-day basis on clinical trials, driving overall progress of study implementation
- Supervises ongoing medical data review
- Ensures on program (where appropriate) and trial 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 other 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)
- Creates input 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.
- Ensures that the Clinical Study Report (CSR) medical content in assigned programs and trials meets high quality expectations on medical standards, provides respective guidance to other members of the clinical development team
- 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.
- Contributes to a collaborate culture within and outside Clinical Development and actively manages best practice sharing and capability building within the clinical team.
What you have to offer.
- M.D. and/or M.D. Ph.D with strong scientific and clinical background in Immuno-Oncology, Oncology or Infectious diseases. Board certification in Oncology/Hematology or Infectious Diseases preferred.
- Minimum of 6 years of experience within Immuno-Oncology, Oncology or Infectious diseases at the biotech/pharmaceutical and the academic setting, including leading clinical development activities, ideally from exploratory Phase I/II clinical trials through late stage development in Phase III and NDA/BLA submission.
- Good understanding of the clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus.
- Ability to write high quality and executable trial designs and protocols.
- Hand-on experience in managing the ongoing clinical day-to-day work for the successful delivery of clinical trials.
- Experience in liaising with clinical operations as well as with epidemiology on regular basis for efficient clinical trial conduct.
- Experiences in preparing and conducting global health authority interactions (e.g. EMA, FDA). Having participated in drug development activities, leading to successful registration is an advantage.
- Deep experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects
- Ability to strategize clinical activities based on a TPP and CDP and translate into trial designs
- Experiences with 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.
- Good understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
- Subject matter expertise on drug development topics, and genuine interest to drive innovation and continuous improvement
- Proficiency in English (written and spoken)
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
BioNTech - As unique as you