AD, Clinical Pharmacology

Location
San Francisco, CA, United States
Posted
May 04, 2018
Ref
3219-341-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary:

The Associate Director Clinical Pharmacology will be responsible for all aspects of the clinical pharmacology for candidate drug products from early development (pre-IND) through late stage development (Phase 3 and NDA filings) using pharmacokinetic, pharmacodynamic, DMPK, translational science and drug therapeutic principles, and knowledge of drug regulatory processes.

Responsibilities:

Develop clinical pharmacology plans, design and direct clinical pharmacology studies, provide scientific leadership in the preparation, conduct and reporting of clinical pharmacology studies. Work cross-functionally to establish clinical protocols and to facilitate the execution of clinical trials. Develop and execute DMPK protocols and pharmacokinetic components of nonclinical protocols. Perform PK and PK/PD data analysis/interpretation, write DMPK, PK, PK/PD, and clinical pharmacology study reports and prepare clinical pharmacology/pharmacokinetic and nonclinical DMPK portions of all relevant regulatory submissions (IND, NDA, etc). Represent clinical pharmacology in cross-functional discussions and participate in creating development and regulatory strategies and planning. Prepare clinical pharmacology presentations. Serves as resource for information regarding nonclinical pharmacology, pharmacokinetics, toxicokinetics, drug metabolism, and bioanalysis within development organization and to regulatory authorities. Participate in writing publications and making scientific presentations consistent with development strategies. Maintains a current knowledge of latest technological/scientific trends/regulatory practices and ensure that clinical pharmacology aspects of development programs are contemporary. Provides scientific/technical guidance, leadership and decision-making as appropriate.

Requirements:

PhD in pharmacokinetics, pharmacology, pharmacy, pharmaceutical sciences or closely related discipline, with a minimum of 10 years pharmaceutical industry experience in designing, analyzing, interpreting, and reporting nonclinical and clinical drug development studies is required. Must be proficient with specialized software for pharmacokinetic data analysis, statistical software such as JMP, and software used to create graphical output and report study results; experience with PK and PK/PD modeling. Candidate must have direct experience in creation of regulatory submissions; experience in interacting with regulatory authorities desired. Must have experience across the range of development phases. Excellent written and verbal communication skills are required; must be able to independently create high quality written reports and summary documents for use in regulatory submissions. Desire to work in a cross-functional drug development team environment with all levels of employees and management; ability to lead such teams is valued. Proven ability to work proactively and effectively. Strong strategic planning, organizational skills, and negotiation and influencing skills.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.