Medical Director, Medical Affairs (Lifecycle Management)

Alkermes

10d•Hybrid

About The Position

This is a high impact position with great visibility, and collaboration, across multiple departments and all levels of the Alkermes organization. This position will have critical responsibilities in the medical affairs group involved in the development of therapies for neurology and neuropsychiatry indications across late-stage programs, contributing to Alkermes’ LCM efforts in neuroscience.

Requirements

MD with experience in Neurology or Psychiatry required
A minimum of 2+ years of experience in the pharmaceutical industry in medical affairs/ clinical development or LCM functions
A business-focused individual, with experience in all aspects of drug development across late-stage clinical programs
Experience interacting with global regulatory agencies, including successful sNDA submissions, label expansions and approvals is highly desired
Outstanding written and verbal communication, with experience interacting with and presenting to senior management and external audiences
Ability to navigate complexity and ambiguity in a highly matrixed work environment
Demonstrated leadership and collaborative interpersonal skills, fostering teamwork and cross-functional partnerships
Self-motivated with the ability to work independently, prioritize tasks efficiently, and meet deadlines
Detail-oriented with expertise in conducting thorough and timely reviews of medical and trial related documents

Nice To Haves

Board Certification in Neurology or Psychiatry preferred

Responsibilities

Responsible for protocol design and execution across late-stage clinical research trials in neurologic disorders
Serve as the LCM Lead for multiple programs, including leadership of the subteams of those programs
Direct authorship contributions in protocols, clinical study reports, study documents, regulatory documents, and external publications
Provide medical oversight of clinical trial data and medical monitoring (in conjunction with a CRO medical monitoring team) of clinical trials supporting sNDA indications and LCM studies
Critically review and contribute to regulatory interactions for LCM studies, sNDAs
Develop LCM plans with cross functional teams and contribute to strategic discussions related to LCM plans and indications
Develop strategy for Investigator Sponsored Studies (ISS) program with cross functional team members and serve on the ISS review committee as a reviewer
Responsible for strategy and execution of product specific global expanded access and compassionate use programs in collaboration with the EAP team
Represent the company to external audiences, including clinical sites, key opinion leaders, and patient advocacy groups
In collaboration with clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met
Ensure that standard operating procedures (SOP) for the LCM team facilitate the development of effective clinical research programs and are compliant with clinical/medical and industry standards
Identify and develop collaborative relationships with key investigators, and key thought leaders globally.
Attend, plan, and oversee lifecycle management clinical advisory boards and investigator meetings, and present at major medical conferences