Job DescriptionThis 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 neurology and neuropsychiatric indications, including sleep disorders. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the 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.
Responsibilities- Responsible for protocol design and execution across clinical research trials in neurologic 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.
Qualifications- Requires an MD with board certification in Neurology
- A minimum of two 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.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. 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.
The annual base salary for this position ranges from $286,000 to $310,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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