What are the responsibilities and job description for the Director, Research Grants & Expanded Access position at Alkermes?
Position Summary
The Associate Director of Research Grants & Expanded Access role within Medical Affairs, oversees and manages all aspects of external research (., Investigator Sponsored Studies (ISS), Collaborations) and expanded access programs. This is an opportunity to fine tune and grow existing programs as well as build a program for products in development. Therapeutic areas include substance use disorders, schizophrenia, bipolar disorder, narcolepsy, and idiopathic hypersomnia. Scope of position may broaden as clinical development programs evolve.
This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
- Oversee and manage all aspects of external research and expanded access programs (., Investigator Sponsored Studies (ISS), Collaborations) from intake of submissions through committee review and execution of studies with oversight from the Director of Grants. Activities include, but are not limited to, ongoing communication with external researchers, managing concept and protocol prep and review sessions, updating externally facing materials, training field-based team members on the scope of the program and compliant communication with external researchers, and facilitating the contracting and invoicing process.
- Oversee and manage all aspects of expanded access programs including collaborating with cross functional partners to establish availability, access criteria, and monitoring of programs in addition to communication with requestors and vendors
- In collaboration with Medical Director(s), develop and manage updates to program strategy including refining areas of interest and developing annual medical plans for the external research programs
- Lead and manage cross-functional ISS and expanded access committee meetings and ad hoc meetings including preparation of all applicable documentation including meeting agendas and minutes
- Maintain program metrics and report program updates to Medical Affairs leadership
- Ensure documentation and systems are in a state of audit readiness
- Work closely with Supply Chain on forecasting study drug supply needs for each program
- Manage the development and updates to SOPs and Work Instructions
- Collaborate with portal vendor on issues or updates
- Maintain a working knowledge of relevant federal regulations governing human clinical investigations and Good Clinical Practice guidelines
- Ability to work independently in a hybrid working model in our Waltham location 3 days / week
- Bachelor of Science Degree required; Master’s Degree preferred
- Minimum of 7 years’ experience; ideally in the pharmaceutical industry
- Experience managing external research programs (. Investigator Sponsored Studies, Collaborations); Strong Clinical Operations experience would be considered
- Experience in initiating and managing expanded access programs
Preferred Qualifications
LI-MB1
