Director, Medical Safety
Gaithersburg, MD, United States
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Director, Medical Safety - Medical Safety Pharmacovigilance Open for hire at one of the following locations –Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube. - Job ID:5187
Become a member of the BioNTech Family!
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, Medical Safety - Medical Safety Pharmacovigilance
The Director of Medical Safety MSPv serves as the scientist lead, in partnership with the Senior Medical Safety Physician, for multiple and/or complex strategically important developmental programs within the oncology and/or infectious disease space.
This role is highly visible in the MSPv and the Global Development Organization and requires working collaboratively as a member of a flexible matrix team to ensure the safety of patients using BioNTech medicinal products.
This is an exciting time to assume a strategic role in MSPv and help translate science into survival by shaping the culture of patient safety for the wider BioNTech organization.
Responsibilities:
Leads the safety surveillance strategy and the presentation of sophisticated safety topics at cross-functional teams and internal governance committees
Participates in safety management teams for assigned products
Provides strategic input and authors periodic safety reports and regulatory health authority (HA) submissions & responses
Partners with the Senior Medical Safety Physician /on the safety strategy for regulatory submissions of new products, formulations, or indications (NDA/BLA, MAA)
Participates in due diligence activities, negotiating the PV agreements and safety components of contracts with vendors
Leads alliance collaboration efforts and represents MSPv at external committees
Ensures activities are performed in compliance with applicable law, global and local regulations, and in accordance with internal and external quality standards
Provides training and mentorship to other MSPv Scientists and entry level safety physicians
Requires 10-15% travel
Requirements:
Bachelor's degree in science/pharmacy/nursing or related health field; Advanced/graduate degree (MS, MPH, PhD, MD, PharmD) preferred
Extensive drug safety/pharmacovigilance experience within the pharmaceutical/biotechnology industry that includes development of innovative drugs, preferably in immuno-oncology/ inflammation therapeutic area(s)
3+ years of medical safety leadership experience, inclusive of establishing program-level safety strategy, proactive signal detection & evaluation, risk identification & mitigation planning for early and/or late-stage clinical assets, preparation & authoring of periodic safety reports, Risk Management Plans, health authority responses, and supporting NDA/BLA/MAA submissions
Has achieved demonstrable results in a matrix organization and in a multidisciplinary team, experience in implementing GCP standards in clinical trials, in particular safety reporting in compliance with global and local regulations
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 ans 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 – Cambridge Erie Street, Gaithersburg, London, Mainz Goldgrube . 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!
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