Medical Director, Medical Affairs (Lifecycle Management)
Alkermes•Waltham, MA
•$270,000 - $305,000•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 neuropsychiatric 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
- 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
- Experience interacting with global regulatory agencies, including successful sNDA submissions, label expansions and approvals is highly desired
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 life cycle management clinical advisory boards and investigator meetings, and present at major medical conferences
Benefits
- Annual performance pay bonus
- Competitive benefits package
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Senior
