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Director, Clinical Pharmacology

Company: Supernus Pharmaceuticals
Location: Rockville
Posted on: June 7, 2021

Job Description:

Job Summary:

The Director, Clinical Pharmacology is a key leadership position at Supernus Pharmaceuticals, Inc. The successful candidate will lead clinical pharmacology activities in support of the clinical programs evaluating efficacy, safety, tolerability, and human pharmacokinetics.

Essential Duties & Responsibilities

  • Design, implementation and execution of clinical protocols, internal strategy and planning documents, final reports and peer-reviewed publications with commercial, statistical, medical affairs, and clinical operational input, among others.
  • 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, commercial teams, and government regulatory agencies.
  • Monitor and interpret results of clinical investigations in preparation for potential commercial partnerships and / or new-drug applications.
  • Manage all PK/PD aspects related FDA documents including but not limited to IND, NDA, sNDA, BLA, and all types of FDA meetings' packages.
  • 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.
  • Direct the analysis and reporting of all quantitative PK/PD activities.
  • Other related but not foreseeable activities as required.

Non-Essential Duties & Responsibilities:

  • N/A

Supervisory Responsibilities:

  • N/A

Knowledge & Other Qualifications:

  • PhD. in pharmaceutical sciences or equivalent and at least 6 years industry experience or equivalent.
  • Unimpeachable sense of ethics in a results driven environment, able to handle the stress and pressure from straddling these two sine qua non requirements.
  • Scientific background with potential for understanding scientific, clinical and operational aspects of the drug development process.
  • Knowledge of pharmacokinetics and pharmacodynamics.
  • Proven ability to manage teams and projects.
  • Ability to clearly communicate clinical, scientific and operational 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, and any other entities necessary.
  • Ability to initiate project efforts in a self-motivated way, including acquiring certain resources (e.g. prospective investigators, publicly available information, etc).

Other Characteristics:

  • Ability to work independently and as part of a team.
  • Maintain highest 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.

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.

#CB

Keywords: Supernus Pharmaceuticals, Rockville , Director, Clinical Pharmacology, Other , Rockville, Maryland

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