Summary
The Associate Director of Clinical Pharmacology will be responsible for all aspects of clinical pharmacology for candidate drug products from early development (pre-IND) through late-stage development (Phase 3 and NDA filings), using pharmacokinetic, pharmacodynamic, DMPK, and drug therapeutic principles, and knowledge of drug regulatory processes. As a key member of the small Translational Medicine & Clinical Pharmacology group, the individual will represent clinical pharmacology on cross-functional teams to oversee the execution of required studies and conduct analyses independently or through CROs to achieve team goals. The candidate will have expertise in clinical pharmacology concepts and hands-on analytical applications. He/She will have the ability to effectively communicate, both in verbal and written form.
Essential Duties and Responsibilities
Contribute to clinical pharmacology plans and/or research plans, design and direct nonclinical PK, clinical pharmacology studies, and work cross-functionally to establish study protocols.
Generate hypotheses and provide strategies for nonclinical PK and clinical pharmacology study types, collaborating closely with cross functional colleagues; Create study protocol concepts and guide study start up activities.
Participate in study teams, provide scientific leadership in study progression including protocol conduct, data analyses, internal decision points and final reporting Independently write nonclinical PK and clinical PK sections in study reports, lead authoring of DMPK and clinical pharmacology summary in regulatory documents (protocol, CSR, Investigator’s Brochure, IND, NDA, MAA, briefing materials, response to queries)
Serve as resource for information regarding nonclinical pharmacokinetics/toxicokinetics, drug metabolism, and clinical pharmacology within development organizations and to regulatory authorities.
Participate in writing publications and making scientific presentations consistent with development strategies.
Maintain knowledge of relevant scientific and regulatory practices and trends and ensure that clinical pharmacology aspects of development programs are contemporary.
May manage internal staffing and performance management, including hiring, training, coaching and performance reviews. Mentors and develops staff.
Education or Degree Requirements
A Bachelors/Masters degree in a scientific discipline is required. PhD in pharmacokinetics, pharmacology, pharmacy, pharmaceutical sciences or closely related discipline is preferred. Equivalent experience may also be considered.
Minimum Professional Experience
Pharm D. or PhD with 5+ years of working experience in a related field; MS with 8+ years' working experience in a related field
Additional Qualifications & Experience
Candidate must have direct experience in creation of regulatory submissions; experience interacting with regulatory authorities desired.
Experience across the range of drug development phases highly desired
Excellent written and verbal communication skills, leadership, initiative and commitment to excellence are required.
Must be proficient with specialized software for pharmacokinetic data analysis, statistical software and software used to create graphical output and report study results
Understanding of autoimmune therapeutic area and biologics highly desired. 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.
ADDITIONAL INFORMATION
Nektar currently anticipates the base salary for the Associate Director, Clinical Pharmacology to range from $185,000 to $220,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and 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. The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
- Health Insurance (Medical/Dental/Vision)
- Disability Insurance
- Holiday Pay
- Paid Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
For general information on company benefits, please go to https://www.nektar.com/careers.
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. will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
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