Assistant Director, Clinical Pharmacology

Supernus • Rockville, MD 20850

Posted 3 weeks ago

Job Description

Job Summary:

The Assistant Director, Clinical Pharmacologyis a key position at Supernus Pharmaceuticals, Inc. The successfulcandidate will lead clinical pharmacology activities in support of clinicalPrograms evaluating the pharmacokinetics and pharmacodynamics s (PK/PD).

Essential Duties & Responsibilities:

* Design, implementationand execution of clinical pharmacology protocols, internal strategy andplanning documents, final reports and peer-reviewed publications withcommercial, statistical, medical affairs, and clinical operational input, amongothers.

* Lead the PK/PD dataanalysis and reporting.

* Lead the PK/PD modelingand simulations activities.

* Work with CMC toestablish an IVIVC plans.

* Lead the translationalmedicine activities by working with the nonclinical group to determine FIMdoses, biomarkers, and pharmacogenomics plans.

* Interact with academics,health authorities, professional consultants and other external resources,including CROs.

* Serve as a clinicalpharmacology consultant to other research project teams, business development,commercial teams, and address regulatory authorities questions related PK/PD.

* Regulatory authoritysubmissions (e.g. IND, NDA etc).

* Identify and evaluate compounds or technologies aspipeline opportunities.

* Monitor changes in thescientific/regulatory/medical environment, which may impact the clinicalpharmacology plans and pharmaceutical marketplace and communicate themappropriately within the organization.

* Other related but not foreseeable activities asrequired.

Non-Essential Duties & Responsibilities:

* N/A

Supervisory Responsibilities:

* N/A

Knowledge and OtherQualifications:

* PharmD, MD, or PhD With 4 plus years ofexperience in quantitative clinical pharmacology.

* Strong knowledge ofPK/PD and modeling and simulations domains.

* Hands on NONMEM and WINNONLIN.

* Proven records of interactions with theregulatory authorities, and IND and NDA submissions.

* Unimpeachable sense ofethics in a results driven environment, able to handle the stress and pressurefrom straddling these two sine qua non requirements.

* Scientific backgroundwith potential for understanding scientific, clinical and operational aspectsof the clinical pharmacology and drug development process.

* Proven ability to manageteam and projects.

* Ability to clearlycommunicate clinical pharmacology and scientific benefits and risks to teammembers and management;

* Ability to maintain andeventually build appropriate relationships with academics, key opinion leaders,professional consultants and other external resources including CROs, and anyother entities necessary.

* Ability to work in aproject team and lead or co-lead projects with operational counterpart.

Other Characteristics:

* Ability to work independently withinmultidisciplinary teams.

* Maintain highest ethical standards of integrity andquality.

* Capable of being innovative and dynamic in approachto work.

* Capable of performing other duties as assigned bymanagement.

* Authorized to legally work in the United Stateswithout visa sponsorship.

SupernusPharmaceuticals is an Equal Opportunity / Affirmative Action employer. Allqualified applicants will receive consideration for employment without regardto race, color, religion, sex, sexual orientation, gender identity, nationalorigin, disability, protected veteran status, age or any other characteristic protectedby law.



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