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DIRECTOR, CLINICAL RESEARCH

Supernus
Rockville, MD
  • Posted: over a month ago
  • Full-Time
Job Description

Job Summary:

The Clinical Research Director is a key leadership position at Supernus Pharmaceuticals, Inc. The successful candidate will report to the Senior Director of Clinical Research. The candidate is expected to lead clinical research activities in support of key initiatives: (1) design and support the clinical development plans and regulatory filing of pipeline products; (2) support clinical research of postmarketing of current marketed products; (3) support evaluation of future research opportunities; (4) collaborate with medical affairs on clinical research activities

Individual will work with clinical research team and will be responsible for preparation of clinical documentation in support of Phase 1-4 clinical studies. The individual will be responsible for the clinical development plans and all the clinical regulatory documents. Experience in psychiatry/neurology is desired. This job summary is not inclusive.

Essential Duties & Responsibilities:

  • Design, implementation and execution of clinical protocols (phase 1-4), internal strategy and planning documents, final reports and peer-reviewed publications with commercial, statistical and operational input
  • Previous proven experience in IND and NDA submissions and interaction with health authorities
  • Co-monitor clinical and scientific adherence to protocols, ethical and good clinical practices
  • Interact with academics, government officials, professional consultants and other external resources, including CROs, to facilitate clinical trials research
  • Serve as clinical and scientific consultant to management, other research project teams, business development, and commercial teams
  • Monitor and interpret results of clinical investigations in preparation for potential commercial partnerships and / or new-drug applications
  • Leads or Co-leads (with commercial colleagues) effort in determining and articulating the attributes related to safety, efficacy, unmet medical need, regulatory approval and successful commercialization of ongoing development and pipeline candidates
  • Identify and evaluate compounds or technologies as pipeline opportunities
  • Monitor changes in the scientific/regulatory/medical environment, which may impact the global drug development process and pharmaceutical marketplace and communicate them appropriately within the organization
  • Develop a recruitment strategy (with Clinical Operations Co-Lead) for all trials as needed
  • Review and manage documents prepared internally and by outside contractors
  • Manage and mentor clinical research scientists
Non-Essential Duties & Responsibilities:
  • n/a
Supervisory Responsibilities:
  • This position may lead and manage team members.

Education:

  • Pharm.D., M.D, or Ph.D. in scientific discipline, preferable in central nerves system (CNS)
Knowledge and Other Qualifications:
  • 8+ years of experience in clinical research, preferable in neurology/psychiatry
  • A high sense of ethics in results driven environment
  • Scientific background with understanding of scientific, clinical and operational aspects of the drug development process
  • Skilled in scientific and clinical research writing
  • Hands on Microsoft Office, e.g., power point, excel, and word documents
  • Ability to clearly communicate clinical and scientific benefits and risks to team members and management;
  • Ability to attain confidence of team and company through personifying professionalism and clinical/scientific knowledge
  • Ability to maintain and eventually build appropriate relationships with academics, government officials, professional consultants and other external resources including CROs
  • Ability to initiate project efforts in a self-motivated way, including acquiring certain resources (e.g. prospective investigators, publicly available information, etc)
  • Ability to work in a project team and lead or co-lead projects with operational counterpart

Other Characteristics:

  • Ability to work independently and as part of a team
  • Maintain high ethical standards of integrity and quality
  • Capable of being innovative and dynamic in approach to work
  • Capable of performing other duties as assigned by management
  • Authorized to legally work in the United States without visa sponsorship
  • Preference for the candidate to work from Rockville, MD,
  • CNS drug development experience is highly desired

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.

Supernus

Address

Rockville, MD
20850 USA

Industry

Healthcare

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