DIRECTOR, PRECLIN DPMK & PHARMACOLOGY

Full Time
Rockville, MD 20850
Posted
Job description

Job Summary:

The position will support Supernus’ drug discovery and preclinical development efforts in the department of Preclinical DMPK and Pharmacology. The individual will be empowered to manage strategic, scientific and operational aspects of multiple drug discovery and development programs from the DMPK perspective. The individual will provide scientific and hands-on implementation of discovery compound screening assays and translational studies for small molecule drug discovery and development with a focus on CNS disorders.

Essential Duties & Responsibilities

  • Lead strategic, scientific and operational aspects of multiple drug discovery and development programs from DMPK/DDI perspective.
  • Ensure completion of high quality DMPK regulatory documentation and reports to support drug development including Investigator Brochures, IND and NDA submissions and independently composing responses to regulatory queries.
  • Manage CROs in the conduct of in vitro/in vivo ADME and in vitro DDI studies.
  • Responsible for timely reporting of study results and interpretation to cross-functional teams.
  • Assist in design, analysis and interpretation of PK/PD studies to address translational questions in support of compound nomination and human active dose prediction.
  • Develop and execute DMPK strategies to address ADME/DDI related issues on discovery and development programs.
  • Implement innovative technologies and approaches to enhance scientific impact and/or efficiencies.
  • Define and assign budget to all DMPK projects.
  • Resolve highly complex business and scientific problems through excellent scientific judgment and broad research, and regulatory affairs knowledge.
  • Communicates with management and provides regular progress updates.
  • Mentor junior staff to promote scientific excellence and individual achievement
  • Other duties as assigned.

Supervisory Responsibilities:

  • N/A

Knowledge & Other Qualifications:

  • PhD in pharmacokinetics, drug metabolism or related discipline with a minimum of 10+ years of relevant work experience. Master’s Degree with 12+ years minimum relevant work experience.
  • Successful drug discovery and development track record with specialization in pharmacokinetics, drug metabolism, and drug-drug interaction.
  • A deep understanding of DMPK and PK-PD principles and hands-on experience in these areas.
  • Experience in CNS drug discovery and development programs.
  • Strong problem solving and collaboration skills.
  • Strength in delivering results on agreed timeline.
  • Strong motivation and independence to work in a dynamic and high-achieving environment.
  • Effective written and verbal communication skills.


Other Characteristics:

  • Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
  • Ability of having an innovative and dynamic approach to work.
  • A self-starter able to work independently but comfortable working in a team environment.
  • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
  • 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.

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