Director, Clinical Pharmacology

Location
San Francisco, CA, United States
Posted
May 04, 2018
Ref
3233-341-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary:

Develop candidate drug products from pre-IND through Phase 3 using drug therapeutic principles and knowledge of drug regulatory processes. Directs clinical pharmacology activities, including design and analysis of in vitro and in vivo ADME studies, pharmacokinetic and pharmacodynamic components of protocols, working with a multidisciplinary team. Conducts and collaborates with others on the principles and theories of quantitative evaluation of new products, maintenance of existing pharmacokinetics and drug metabolism product lines, and application of biomarker strategies through the application of state-of-the-art knowledge in pharmacokinetics, translational medicine, and bioanalysis. May make decisions impacting pharmacokinetic/ pharmacodynamic/translational medicine goals and the success and relevance of individual preclinical and clinical studies. Develops strategies to ensure effective achievement of clinical and drug development objectives. Manages the design and preparation of preclinical and clinical pharmacokinetics development strategies and study protocols, performing and supervising pharmacokinetic and pharmacodynamic analyses, and preparation of clinical studies reports and integrated summary documents. Provides feedback and direction for regulatory submissions preparation and review support for new or existing products. Works closely with clinical operations, biostatistics, data management, research, drug metabolism and therapeutics areas. Develops strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects. Develops budgets for operating and capital expenditures and labor. Typically participates with other top managers to establish company policies. Makes final decision on administrative or operational matters. Selects, develops, and evaluates personnel to ensure the efficient operation of the function. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Identifies preclinical data (e.g., ADME, pharmacology,PK/PD, etc.) needed for preclinical development, and for design of clinical studies and development plans. Develops detailed preclinical and clinical development plans and leads execution of programs acceptable to regulatory authorities; apply principles of drug development science and regulatory science to build thorough but efficient preclinical and clinical development plans. Participate with various internal and external disciplines in the research and development of drug product candidates. Lead Clinical Pharmacology activities for assigned products in clinical development. Prepare for and participate in Business Development and Due Diligence activities. Establishes goals, structures experiments, analyzes and reduces data, recommends and plans actions to achieve project objectives. Hires and trains staff at appropriate levels of need, coordinates annual reviews, and counsels junior staff on career related subjects. Provides scientific/technical guidance, leadership and decision-making as appropriate. Provides regular performance feedback, development and coaching to direct reports.

Requirements:

A Ph.D. in a health sciences discipline is required. Equivalent experience may be accepted. A minimum of 13 years experience in pharmaceutical research and development in a pharmaceutical industry setting required. A minimum of 10 years previous management experience is desired. Knowledge of oncology, immune-oncology, and immunology drug development required. Prior experience with small and large molecules is a plus. Excellent scientific writing, communication, presentation, documentation, and computer skills are mandatory. Experience with the use of ADME, PK and PK/PD methods, modeling and simulation, statistics, etc to streamline drug development and experience in creating IND-level regulatory submissions and interacting with regulatory authorities is required. Desire to work in cross-functional drug development team environment with all levels of employees and management; ability to lead such teams is valued. Expertise in pharmaceutical research /development is a must. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. Must have a demonstrated ability to work with senior management. Must be goal-oriented, quality-conscientious, and customer-focused. Good laboratory compliance and safety practices are a must. Demonstrated ability to develop successful relationships with and influence customers, both internal and external. Understands how to set expectations and negotiate proper milestones to track progress. Must have strong 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.