AD, Pharmacometrics

Location
San Francisco, CA, United States
Posted
Jun 12, 2018
Ref
2-1-3220-341-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Summary:

Nektar Therapeutics is seeking an experienced pharmacometrician to join the company at the Associate Director (AD) level. The position is in our expanding Pharmacometrics group and the new AD will work closely with other modelers and non-modelers to advance drug candidates from preclinical to late clinical phases by applying state of the art quantitative analysis techniques..

Nektar Therapeutics continues to advance a model-based drug development paradigm throughout the organization. The current position offers an exciting opportunity to be a contributing part of the company's efforts in promoting quantitative analysis techniques at all stages of drug development. We offer a highly collaborative and scientific environment and the opportunity to shape the future of the company's path toward a more effective and model-based drug development process.

Responsibilities:

Help apply quantitative analysis methods and PK/PD modeling techniques in developing candidate drug products from preclinical through Phase 3 studies. Serve as an expert to all relevant disciplines and ensure that modeling and simulation (M&S) methods are utilized optimally in discovery and development activities. Plan and execute PK/PD M&S activities in the design and analysis of in vivo and in vitro studies working with a multidisciplinary team. Represent the Pharmacometrics group in project team meetings, collaborating with others on the principles and theories of quantitative evaluation of new products. In collaboration with other members of project teams, make decisions impacting PK/PD analysis goals and the success and relevance of individual preclinical and clinical studies. Contribute to 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 study reports and integrated summary documents. Provide feedback and direction for regulatory submission preparations and review support for new or existing products. Work closely with clinical operations, biostatistics, data management, research, drug metabolism, and therapeutics areas. Contribute to the development and implementation of guidelines and SOPs within the Pharmacometrics group. Provide scientific/technical guidance, leadership, and decision-making as appropriate. Provide regular performance feedback, development, and coaching to direct reports, if any.

Requirements:

A minimum of PhD in pharmacokinetics/pharmacodynamics or pharmacometrics is required. Other relevant backgrounds may be considered. A minimum of 6-8 years of experience in designing, analyzing, and reporting nonclinical and clinical drug development studies is required. Equivalent experience may be accepted. Must be proficient in creation and management of datasets with working knowledge in the use of R or SAS in creating data files for pharmacometrics analysis. Proficiency in the use of major PK/PD software such as WinNonlin, Monolix, or NONMEM is required, as is working knowledge of software used to create graphical output and report study results. Strong 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 is valued. Must be goal-oriented, quality-conscientious, and project-focused, with demonstrated ability to develop successful influential relationships with colleagues, both internal and external. Must be self-driven and be able to work independently or with little supervision to set expectations and negotiate proper milestones to track progress.

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.