Director, Clinical Pharmacology
Company: Supernus Pharmaceuticals
Posted on: June 7, 2021
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
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
- Manage all PK/PD aspects related FDA documents including but
not limited to IND, NDA, sNDA, BLA, and all types of FDA meetings'
- Identify and evaluate compounds or technologies as pipeline
- 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
- Other related but not foreseeable activities as required.
Non-Essential Duties & Responsibilities:
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
- 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
- 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).
- Ability to work independently and as part of a team.
- Maintain highest ethical standards of integrity and
- Capable of being innovative and dynamic in approach to
- Capable of performing other duties as assigned by
- Authorized to legally work in the United States without visa
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.
Keywords: Supernus Pharmaceuticals, Rockville , Director, Clinical Pharmacology, Other , Rockville, Maryland
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