Medical Director / Senior Medical Director* - Infectious Diseases

  • BioNTech Careers
  • Cambridge, MA
  • Work experience
  • Senior, very experienced
  • Research, development, teaching
  • Published: 03.02.2021
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Become a member of the BioNTech Family!

Medical Director, Senior Medical Director  
 
Name: BioNTech United States Inc.  
Purpose: BioNTech’s vision is to become the leading global biotechnology company providing individualized treatments for cancer patients,  improved therapeutics to treat infectious and rare diseases, and advance highly effective vaccines to prevent infectious diseases.
Ownership: Wholly owned subsidiary of BioNTech SE
Location of Position: Cambridge, MA
Location of Headquarters: Mainz, Germany (near Frankfurt)
 
Company Overview: 
 
BioNTech was founded in 2008 on the understanding that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized. Its cutting-edge pipeline includes individualized mRNA-based product candidates, innovative chimeric antigen receptor T cells, novel checkpoint immunomodulators, targeted cancer  antibodies and small molecules.
 
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies and vaccines to prevent infectious diseases; as such the group expects to experience significant growth in the near future. BioNTech US is a  subsidiary of BioNTech SE with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
 
BioNTech's strategy is to establish and leverage the building blocks of immunotherapy and prophylactic vaccines:
  • Our technology platforms and clinical pipeline are based on 20 years of research and development expertise.
  • Fully integrated biotech company spanning research through clinical development and manufacturing
  • Unique, differentiated licensing, co-development and co-commercialization agreements make BioNTech a development partner on a level playing field.

The RNA-based platform, when considered as a potential prophylactic or therapeutic vaccine, has multiple advantages over other vaccine platforms such as DNA, protein subunit, inactivated or live-attenuated virus vaccines. These considerations include the following: safety (non-infectious, non-integrating), efficiency for in vivo expression and delivery of antigens, easy formulation into carrier molecules, more efficient manufacturing, etc. These advantages coupled with the observation that RNA vaccines induce potent antibody and T cell responses to the target antigen led to the rapid dvelopment of a prophylactic vaccine to address the SARS-CoV-2 pandemic and to establishment of collaborations to address prevention of other infectious diseases.
 
Company Values
 
BioNTech's corporate values represent what we consider to be important and what we would like to stand for as a company. They serve as a practical orientation and shape our corporate identity.
 
BioNTech stands for visionary thinking and pioneering spirit – with our work we want to revolutionize cancer immunotherapy and address infectious diseases that burden global human health.

Innovation and new ways of thinking in all areas of work therefore are the cornerstones of our success.
Passion and enthusiasm guide our daily work and everything we do.
Unidarity* is the basis to achieve our ambitious goals successfully, together – with our employees as well as in interactions with our partners. (* Unidarity is a neologism derived from unity and solidarity)
 
Company Website: www.biontech.de
 

Medical Director / Senior Medical Director* - Infectious Diseases

The Medical Director/ Senior Medical Director is recognized within BioNTech as the medical lead for one or more assets entering clinical development phase. The successful candidate will have multiple opportunities to lead the design and execution of development strategies, from pre-IND to BLA.  They will work closely with exceptional preclinical and clinical scientists in implementing these development plans. There is extensive opportunity for interactions with company senior management, and externally with highly-recognized clinical investigators in the US and throughout the world.
 
Responsibilities include
 
  • Provide leadership and coordination with multiple research functions on key clinical efforts.
  • In collaboration with the Clinical Operations, coordinate study activities in the assigned program(s) within the overall Clinical Development Strategy led by the Infectious Disease Program Lead.
  • Co-lead development of the Clinical Strategy/Clinical Development Plan and provide medical oversight into protocol development, data generation, and reporting.
  • Oversee Phase I-IV clinical development programs to ensure that regulatory requirements and quality standards are met. Strive to maintain or exceed compliance obligations for Good Clinical Practices guidelines and standard company operating procedures.
  • Act as a company representative in interactions with external scientific leaders and regulatory authorities:
  • Search and analyze medical literature, write/review abstracts, manuscripts, etc., for publications and/or presentation at internal/external meetings
  • Lead/participate in investigator meetings and advisory committee meetings
  • Lead/participate in strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with a clinical development program.  Responsibilities may also include post marketing commitments and life cycle management initiatives.
  • Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol
  • Co-lead product safety review committees as appropriate
  • Provide consultation on medical subjects to investigators and other company personnel, and apply medical knowledge to guide the safe, ethical, and efficient conduct of trials

What you have to offer.

Essentials:
  • MD or equivalent
  • Subspecialty training in infectious diseases, immunology with a minimum 3 years academic and/or industry experience
  • Demonstrated potential or ability to design, initiate, and conduct clinical studies
  • Practiced in clinical study design, in academia and/or industry
  • Proven ability to analyze and interpret efficacy and safety data relating to immunology and/or infectious disease prevention and/or treatment
  • Able to work across many interfaces (clinical/clinical operations, clinical/project management, clinical/regulatory, clinical/commercial, etc.)
  • Demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global matrix team environment
  • Strong and effective communication skills (written and verbal); excellent medical/scientific writing skills
  • Personal ethical integrity and a commitment to improving the infectioius disease area of global health
 
Preferred:
  • Postgraduate training/certification/fellowship in drug development or in a medical discipline
  • Experience in regulatory interactions throughout the different phases of development
  • Experience and solid understanding of drug developing strategy and process

Benefits for you.

  • Medical, Dental and Vision Insurance
  • Life, AD&D, STD and LTD Insurance
  • HSA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and free onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more! 

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form.

If you have any further questions, Dave Anderson will be happy to answer them on 508.656.0580 (monday-friday, from 12 noon).

*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. #LI-DCA

BioNTech - As unique as you

https://biontech.de