About the Company
Gemini Therapeutics is a biotechnology company pioneering precision therapeutics for patients with high-risk genetic profiles linked to dry age-related macular degeneration (AMD) and rare systemic diseases. Their therapeutic candidates are matched to molecular abnormalities found in patients with high clinical need and Gemini’s broad multimodal pipeline includes monoclonal antibodies, recombinant proteins and gene therapies. Launched with funding from leading life science investors and powered by academic partnerships around the world, Gemini is developing a series of first-in-class therapeutics. The company currently has 30 employees, and more information is available at www.geminitherapeutics.com.
About the Role:
Reporting to the VP of Clinical Development , the Director of Safety/Pharmacovigilance is responsible for providing oversight and day to day management of all activities pertaining to product safety and pharmacovigilance in clinical development and post-marketing surveillance, The Director of Safety/Pharmacovigilance ensures that appropriate medical safety assessments and surveillance, compliant regulatory authority reporting, development and implementation of risk management strategies, and communication of safety information for Gemini Therapeutics products, are globally completed.
- Advance and maintain the safety governance oversight for all Gemini Therapeutics products
- Responsible for ongoing safety data review and signal detection, management of serious adverse event reporting, aggregate safety reporting, management of risk-benefit profiles, risk management and mitigation plans for all clinical stage programs
- Directly oversee PV external resources to ensure high quality case processing and aggregate reporting, as well as ensuring appropriate documentation and governance frameworks are in place
- Lead process improvement within pharmacovigilance – including technology assessment and implementation
- Collaborate with appropriate clinical operations, clinical development, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including authoring as appropriate and review of documents such as DSUR, IB, clinical study protocols, informed consent forms, DSMB charters, development plans, and INDs/CTAs
- Provide safety expertise to other Gemini therapeutic functions
- Represent PV in audits with health authorities and development partners
- Oversee development of training modules and provide training in Pharmacovigilance across the Company
- MD, PhD degree or equivalent preferred
- At least 8 years of pharmaceutical industry experience, including at least 5 years in pharmacovigilance management roles
- Previous experience with clinical trials and knowledge of Good Clinical Practices, regulatory requirements for the conduct of clinical trials
- Previous experience with data safety monitoring board; charter development, data sharing, reporting
- Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
- Ability to work collaboratively with the internal partners and ability to build relationships with clinical sites and outside vendors
- The ability to work under pressure to meet deadlines, the ability to handle complex projects and to overcome delays and obstacles, and excellent team member and interpersonal skills are required
- Attention to details, able to proactively identify issues and propose solutions
- Excellent written and verbal communication skills
- Experience in ophthalmology a plus
Gemini Therapeutics will consider Remote workers for this role.