Safety Evidence Generation Lead
Location- Candidates must live in an East Coast state in the US (please note those who live outside of ET will not be considered)
Remote role and occasional travel to HQ in Europe may be required
Right to Work in the US in required
About the Company
We are working with a European biotech organisation, who are developing novel therapeutics for a range of rare diseases. They have achieved FDA success with a few of their programs, which are now launching into further markets around the world. The portfolio ranges from preclinical to approved products, with multiple new indications currently being explored across multiple rare indications.
About the Role
This role is an exciting opportunity to join as a Safety Evidence Generation Lead. Sitting in the global patient safety group, a new team focused on Safety Evidence Generation was established a year ago, and is now looking to add a new role to the team due to recent progress & expansion of the pipeline. This role combines medical & scientific expertise with data analytics, to ensure a full understanding of the safety profile of products & communication to various stakeholders. Deep understanding of trends in competitor safety profiles is required in this role.
This role will be responsible for conducting a post-authorisation safety study, including analysis of competitor data, setting up studies, being the primary medical safety resource during the study & presenting the safety data to internal & external stakeholders.
We are looking for candidates who have the below experience:
- Prior experience of assessing safety in pregnancy, or clinical studies experience within gynaecology/ obstetrics / women's health is required for this role.
- Drug safety experience within post-authorisation studies will be highly beneficial, those with both early & late phase clinical development experience within drug safety will also be considered
- Medical Degree (MD) is preferred, but those with PhD, PharmD or similar education will also be accepted
- Strong knowledge of clinical development for pharmaceuticals (ideally biologics) is required.
- Rare Disease or Orphan Drug experience will be beneficial but not essential
- A willingness to work operationally and "hands-on" when required to get tasks completed
- A desire to work in a biotech environment which can be fast-paced & demanding, whilst also being able to adapt to any strategic changes in pipeline direction.
Please apply with an up to date CV for consideration.
