Executive Director, Clinical Development (Sleep Specialist)

Hiring By - Biostaffic

 BioPharma

Waltham, Massachusetts - United States

Job Highlights

Not Disclosed

Director

Posted 4 months ago
Job details
Position Overview
This is a high impact position with great visibility across all levels of the Alkermes organization.
This position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for neurology indications, including sleep disorders. Key domains include development of study protocols, medical review of clinical trial data and generation of clinical study reports. The Executive Director will 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 the protocol design across all clinical research trials in sleep disorders.
  • Direct authorship contributions in protocols, clinical study reports, and publications.
  • Interact with senior management and serve as a standing member of project team meetings.
  • Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations.
  • In collaboration with the 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 protocols 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 and investigator meetings.
  • Critically review and contribute to regulatory interactions (such as INDs and NDAs).
Skills, Education And Experience
  • Requires an MD with a Neurology background, Board Certified preferred with extensive clinical and academic experience in sleep medicine.
  • At least five years of experience in the pharmaceutical industry.
  • A business-focused individual, with experience in all aspects of drug development, including in-licensing. A person who has built on their medical expertise and successfully applied this to enhance the development and commercialization of new chemical entities (NCEs).
  • Experience with successful NDA submissions and approvals and interactions with regulatory agencies are 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; demonstrated business acumen.
  • 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 legal 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.
PDN-995d8d05-8dc8-4f9c-a005-ea69f3f0355a

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Waltham, Massachusetts - United States

Experience:

  • Director

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Professional Diversity Network
Professional Diversity Network

Current Openings: 0

Connecting Diverse Professionals to Employers That Value Diversity Our mission is to provide diverse communities with a trusted professional network, which pairs members with employers who are serious about building a diverse workforce to meet the needs of an increasingly diverse customer base. ProDivNet makes your job search as productive as possible because the employers who post on our site are specifically seeking to hire aspiring diverse employees. Our matching technology guarantees that members will secure the very best possible match for their skills, experience and other priority criteria they have listed. About Us As one of seven culturally distinct websites in The Professional Diversity Network provides a professional network for diverse talent that is far more engaging and welcoming than a typical job board. The affinity of culture shared by members encourages valuable relationships with peers and mentors who are invested in each other’s success and are happy to help them improve their career skills and their access to opportunity. ProDivNet has taken the job search from what is all too often, lonely and discouraging experience to a communal one that motivates and inspires members along their journey to achieve their life goals.
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