Who we are
EmbarkNeuro is a neuroscience focused biotech portfolio company of Aditum Bio, the biotech investment firm co-founded in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research (NIBR) Dr. Mark Fishman. EmbarkNeuro is a portfolio company focused on neuroscience, with a Phase II ready asset in treatment-resistant depression. The company was formed following the successful in-licensing of a selective vasopressin 1b receptor (V1b) antagonist (ANC-501) from Taisho Pharmaceutical Co., Ltd. At EmbarkNeuro, we are: patient centric, collaborative, curious and courageous.
Position Summary
Note: This is a part-time position, with the possibility of moving to full-time in the future
The Head of Drug Safety and Pharmacovigilance is responsible for leading the overall planning, oversight and execution of EmbarkNeuro’s safety processes in all phases of clinical development (I-III). The Head of Drug Safety and Pharmacovigilance will establish, grow and lead the critical areas of safety science and pharmacovigilance strategy and operations for EmbarkNeuro. This newly created position provides an opportunity to build a function from the ground up. The Head of Drug Safety and Pharmacovigilance will ensure compliance with pharmacovigilance regulations, provide guidance to clinical teams, synthesize safety data in order to make informed recommendations to leadership and project teams, own risk management and assessments, and liaise with cross functional partners[EH1] both internally and externally as EmbarkNeuro’s Safety leader and expert. The role requires an ability to work in a dynamic, start-up environment and is the senior most role in Patient Safety and will report to the Chief Executive Officer.
Specific Responsibilities
- Define the Safety strategy, governance and leadership for DSPV at EmbarkNeuro
- Responsible for all aspects of patient safety in collaboration with Clinical Development for all EmbarkNeuro drugs in development
- Oversight of Safety Science and PV operations, including:
- Select, manage and oversee all CRO safety-related activities
- Safety signal detection
- Engagement of external expertise, when necessary
- Responsible for the development of the Safety approach of the development programs including protocols, Investigator
- Brochures and all other critical documents (e.g., clinical study, protocols, and amendments, ICFs, IBs, IMPDs, support DSMB, clinical safety reports, INDs, CTAs)
- Provide oversight and prepare safety documentation, such as safety reports and risk assessments
- Management of the existing and growing DSPV team, both employees and contractors
- Collaborate and communicate safety issues with all cross-functional areas
- Monitors best practices and recommends changes to existing policies and SOPs as needed
- Leads the team in response to safety questions from regulatory agencies
Qualifications
- MD or advanced life sciences degree
- At least 10 years of industry experience in drug safety/pharmacovigilance
- At least 5 years project and line management experience overseeing PV staff including scientific staff and PV operations of employees and/or consultants and CROs
- Ability to thrive in a virtual and/or outsourced model; preference for at least 5 years in a small biotech environment
- Experience in neuroscience TA a plus
- Strong track record in effectively working with senior management
- Excellent understanding of clinically relevant ICH GCP guidance and FDA regulations.
- Experience in all phases of drug development, with emphasis on phases I & II
- Proven ability to work collaboratively internally and externally, with the ability to manage multiple stakeholders