Director, Clinical Pharmacology

Supernus Pharmaceuticals, Inc.
Rockville, MD
Aug 15, 2022
Aug 17, 2022
Full Time
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 & ResponsibilitiesA cents € cents 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.A cents € cents Monitor clinical and scientific adherence to protocols, ethical and good clinical practices.A cents € cents Interact with academics, government officials, professional consultants and other external resources, including CROs, to facilitate clinical trials research.A cents € cents Serve as clinical and scientific consultant to management, other research project teams, business development, commercial teams, and government regulatory agencies.A cents € cents Monitor and interpret results of clinical investigations in preparation for potential commercial partnerships and / or new-drug applications.A cents € cents Manage all PK/PD aspects related FDA documents including but not limited to IND, NDA, sNDA, BLA, and all types of FDA meetings' packages.A cents € cents Identify and evaluate compounds or technologies as pipeline opportunities.A cents € cents 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.A cents € cents Direct the analysis and reporting of all quantitative PK/PD activities.A cents € cents Other related but not foreseeable activities as required.Non-Essential Duties & Responsibilities:A cents € cents N/ASupervisory Responsibilities:A cents € cents N/AKnowledge & Other Qualifications:A cents € cents PhD. in pharmaceutical sciences or equivalent and at least 6 years industry experience or equivalent.A cents € cents Unimpeachable sense of ethics in a results driven environment, able to handle the stress and pressure from straddling these two sine qua non requirements.A cents € cents Scientific background with potential for understanding scientific, clinical and operational aspects of the drug development process.A cents € cents Knowledge of pharmacokinetics and pharmacodynamics.A cents € cents Proven ability to manage teams and projects.A cents € cents Ability to clearly communicate clinical, scientific and operational benefits and risks to team members and management;A cents € cents Ability to attain confidence of team and company through personifying professionalism and clinical/scientific knowledge.A cents € cents 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.A cents € cents Ability to initiate project efforts in a self-motivated way, including acquiring certain resources (eg prospective investigators, publicly available information, etc).Other Characteristics:A cents € cents Ability to work independently and as part of a team.A cents € cents Maintain highest ethical standards of integrity and quality.A cents € cents Capable of being innovative and dynamic in approach to work.A cents € cents Capable of performing other duties as assigned by management.A cents € cents 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.

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