Job Description:

Position Summary

The Associate Director of Research Grants & Expanded Access role within Medical Affairs, oversees and manages all aspects of external research (e.g., 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.

Responsibilities

• Oversee and manage all aspects of external research and expanded access programs (e.g., 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

Qualifications

• 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 (e.g. Investigator Sponsored Studies, Collaborations); Strong Clinical Operations experience would be considered


• Experience in initiating and managing expanded access programs

Preferred Qualifications

• Strong project management and/or operations experience


• Self-motivated, flexible, resourceful, independent thinking and problem solver


• Experience with iEnvision for Grants or similar portal is strongly preferred


• Ability to collaborate cross-functionally as well as work autonomously


• Ability to prioritize and manage multiple projects


• Knowledgeable or confident with various technology, including Excel and PowerPoint, SharePoint, SmartSheet, and/or Tableau. Ability to run reports, identify metrics, and pull insights from data.


• Navigates organizational network proficiently


• Exhibits advanced writing skills, strong communication skills, and the ability to present complex topics to scientific leadership committees
  
  

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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