Sr. Director, Clinical Pharmacology

I. Job Summary

• Develop candidate drug products from pre-IND through Phase III using drug therapeutic principles and knowledge of drug regulatory processes.
• Directs the activities of a pharmacokinetic/ pharmacodynamic group or external clinical pharmacology vendor in the design and analysis of in vivo and in vitro pharmacokinetics and drug metabolism studies working with a multidisciplinary team.
• Works closely with Research and Development to implement stage-appropriate (exploratory) clinical development plans and initial product labeling targets that will lead to IND-enabling studies, and Phase I to III clinical protocols acceptable to global regulatory authorities.
• Conducts and collaborates with others on the principles and theories of quantitative evaluation of new products and maintenance of existing pharmacokinetics and drug metabolism product lines through the application of state-of-the-art knowledge in pharmacokinetics and bioanalytical chemistry.
• 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, performs and supervises pharmacokinetic and pharmacodynamic analyses, and prepares clinical studies reports and integrated summary documents.
• Provides feedback and direction for regulatory submissions preparation and reviews support for new or existing products. Works closely with clinical operations, biostatistics, data management, research, drug metabolism and clinical development areas.
  
  
  

II. Minimum Qualifications

A minimum of a Bachelors degree in a scientific discipline is required. A Ph.D. in a health sciences discipline is highly desired/required and some knowledge and understanding of immunology desired. 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 8 years previous management experience is desired.

• Excellent scientific writing, communication, presentation, documentation, and computer skills are required.
• 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.
• Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
• Experience and understanding of ICH, and GCP is required.
• Demonstrated ability to work in cross-functional drug development team environment with all levels of employees and management required; ability to lead such teams valued.
• Expertise in pharmaceutical research /development is a must.
  
  
  

III. Additional Information

Nektar Therapeutics (Nektar) currently anticipates the base salary for the Director / Sr. Director, Clinical Pharmacology to range from $225,000 to $350,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical / Dental / Vision)
• Disability , Life & Long - Term Care Insurance
• Holiday Pay
• Paid-Time Off (PTO)
• 401(k) Plan Match
• Employee Stock Purchase Plan
• Wellness Programs
• Parental Leave Benefits (in accordance with the terms of the applicable plans)
  
  
  

For general information on company benefits, please go to https://www.nektar.com/careers .