Sr. Medical Director, Clinical Development (Psychiatry)

Alkermes

3d•Hybrid

About The Position

This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical responsibilities in the clinical department involved in the development of therapies for neuropsychiatric indications. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the Sr Medical Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project management, patient engagement, health economics, legal, finance, medical affairs and commercial.

Requirements

Requires an MD with drug development experience in psychiatry
At least 5-7 years of experience in the pharmaceutical industry
A business-focused individual, with experience in all aspects of drug development across early and late stage clinical programs
A person who has built on their medical expertise and successfully applied this to enhance the development of new chemical entities (NCEs)
Experience interacting with global regulatory agencies, including successful NDA or BLA submissions and approvals, is highly desired
Outstanding written and verbal communication, with experience interacting with and presenting to senior management and external audiences
Ability to manage complexity and ambiguity in a highly matrixed work environment
Displays strong leadership and collaborative interpersonal skills
Ability to work independently, prioritize tasks efficiently, and meet expected time frames
Ability to perform thorough reviews of various medical and trial related documents in a timely manner

Responsibilities

Responsible for protocol design and execution across clinical research trials in neuropsychiatric disorders
Serves as the Global Clinical Lead for 1 or more programs, including leadership of the clinical subteams of those programs
Direct authorship contributions in protocols, clinical study reports, study documents, regulatory documents, and external publications
Provide medical review of clinical trial data and medical monitoring (in conjunction with a CRO medical monitor) of Phase 2 and Phase 3 clinical trials
Interact with senior management and serve as a standing member of one or more project team(s)
Contribute to strategic discussions related to clinical development plans and indication prioritization
May include mentoring of more junior clinical research colleagues and/or clinical scientists
Represent the company to external audiences, including clinical sites, industry partners, 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 Clinical Development 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 and oversee clinical advisory boards, investigator meetings, and attend and present at major medical conferences
Critically review and contribute to regulatory interactions (such as INDs and NDAs)
Depending on level, may participate in business development activities