Senior Clinical Pharmacologist II

Davita Inc. • King of Prussia, Montgomery County, United States • $200k - $250k / year • 3m ago

SUMMARY/JOB PURPOSE:

The Senior Clinical Pharmacologist II has strong scientific and technical skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of development. Working closely with partners from discovery and development, the individual is responsible for providing strategic and technical matter expertise as a member of study or project development team.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Develop and implement clinical pharmacology and pharmacometric strategies to drive Exelixis programs through all the stages from research through post-marketing.
Serve as the clinical pharmacology lead on study or project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions and quantitative pharmacology.
Progress small molecules and biologics through development milestones including IND/CTA, EOP2 and marketing applications.
Conduct PK/PD and exposure-response analyses using relevant state-of-the-art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publications.
Work collaboratively with functional partners including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations and Regulatory to deliver on the project team and corporate objectives.
Work with internal and external scientific experts to evaluate new methods to maintain cutting-edge techniques, models, and capabilities.
Assure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards in clinical pharmacology programs.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

PhD in Pharmaceutical Sciences, or a related field, or a related discipline and a minimum of 2 years of relevant drug development experience; or,
Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Minimum 2 years post-graduate experience in clinical pharmacology and/or pharmacometrics.
Experience with development of small or large molecules.

Knowledge/Skills:

In-depth understanding of the principles of clinical and quantitative pharmacology.
Candidates with hands-on modeling and simulation skills using NONMEM, R and/or other modeling and simulation software are preferred.
Current knowledge of regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biologics.
Strong interpersonal, verbal, and written communication skills and the ability to convey complex technical information clearly.
Ability to communicate and collaborate cross-functionally.
Ability to develop and deliver effective presentations and written/oral communications.
Thrives in a fast-paced business environment.
Applied knowledge of GLP and GCP regulations.

JOB COMPLEXITY:

Function in a highly matrixed team environment.
Find creative solutions to unique and complex problems.

DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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