Director* Clinical Development

Open for hire at one of the following locations –  Shanghai. - Job ID: 7257 

 

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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.


 

Director* Clinical Development 

 

The Director* Clinical Development will work hand-in-hand with the VP of Clinical Development and the Senior Director Clinical Development to steer clinical strategies and their operationalization for the assigned programs. He/ She will work on 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 and medical knowledge, including patient safety and data integrity.

 

Primary responsibilities :

  • Oversee and steer the design and execution of clinical trials of their assigned programs, helping to create the clinical development plan for new compounds, and pave a path towards regulatory approval. 
  • Works hand-in-hand with the Senior Director Clinical Development and VP of Clinical Development to drive clinical strategies and their operationalization in programs and trials. 
  • Drives operational planning, content, execution and delivery for assigned programs and studies. Will manage day-to-day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities and communicating with investigator / sites where appropriate.  
  • Assumes Trial 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 Trial 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 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
  • Responsible for  ongoing medical monitoring activities  including medical data review 
  • Ensures at the program and trial level, that the clinical development team works hand-in-hand with Clinical Operations team, with a focus onpatient centric drug development, ensuring 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,  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. 
  • Creates Clinical Study Report (CSR) medical content and ensures it meets high quality expectations on medical standards, 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 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. with strong scientific and clinical background in Immuno-Oncology, Oncology 
  • Minimum of 5 years of experience within Immuno-Oncology, Oncology 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 regulatory submissions. Total 12 years’ experience in related area. 
  • Good understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities. 
  • Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage. 
  • Strong medical experience in medical monitoring including overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects. 
  • Functional and/or disciplinary leadership experience with proven track record of leading teams is a plus
  • Ability to strategize clinical activities based on a TPP and CDP and translate into trial designs 
  • Ability to write high quality and executable trial designs and protocols
  • 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.
  • Subject matter expertise on drug development topics, and genuine interest to drive innovation and continuous improvement
  • High 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 – ShanghaiApply 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!