Note: The job is a remote job and is open to candidates in USA. Nektar Therapeutics is seeking a Director, Clinical Development to provide scientific leadership for global Phase 2 and Phase 3 clinical programs. The role oversees trial design and execution, leads cross-functional collaboration, reviews clinical documentation and data, supports regulatory submissions, and communicates with health authorities, investigators, and internal and external teams.
Responsibilities
- Leads the scientific design and clinical oversight of global Phase 3 trials, ensuring study design alignment with the target product profile (TPP)
- Serves as the primary clinical representative on the Global Study Team, collaborating with Regulatory Affairs, Biostatistics, and Clinical Operations to maintain project timelines
- Leads cross‑functional development of clinical data collection, monitoring, and signal detection strategies, and actively participates in ongoing study data review
- Synthesizes study-level observations into clear recommendations for senior clinical development leadership
- Reviews template informed consent forms, study charters, manuals, work instructions, case report form specifications, and statements of work to ensure accuracy, protocol alignment, and consistency with the Investigator Brochure(s)
- Develops study training materials and delivers training to internal teams, external partners, and investigational site staff
- Drafts and manages responses to health authority and ethics committee questions, site inquiries regarding protocol interpretation, and data clarifications
- Participates in cross‑functional working groups to provide clinical input into the development of program‑wide processes
- Contributes to and reviews Investigator Brochures, data presentations, and scientific publications
- Collaborates on the development of clinical study reports and supports preparation for potential NDA and BLA submissions
- Conducts and presents literature analyses to assess the evolving therapeutic landscape and inform clinical research objectives
Skills
- Demonstrates well‑rounded experience in clinical trial design and conduct, including knowledge of GCP and ICH guidelines, a solid understanding of functional roles within drug development, and a proven ability to collaborate effectively on cross‑functional clinical study teams
- Exhibits strong oral and written communication skills, with the ability to clearly convey scientific information and present technical concepts to both technical and non‑technical audiences
- Demonstrates independent research capability, sound judgment, strong organizational skills, and effective problem‑solving and conflict‑resolution skills
- Brings experience writing, editing, and reviewing clinical documents, including protocols, investigator brochures, informed consent templates, study manuals, vendor charters, conference presentations, and journal publications
- Effectively engages with key opinion leaders, investigators, coordinators, and site staff to exchange scientific input related to protocol development and study execution
- Demonstrates strong matrix leadership skills with the ability to influence peers across Operations, Regulatory, and Statistics functions, as well as a track record of technical proficiency, scientific creativity, collaboration, and independent thinking
- Maintains current, active engagement in the field and demonstrates expert knowledge of scientific principles internally and externally, with sustained performance and accomplishment
- Experience working in an FDA‑regulated environment and knowledge of GMPs as they apply to laboratory practices are highly desired
- 8-10 years of work experience in a research and/or development with a minimum global Phase 3 studies managed through start-up and/or database lock
- Experience in Immunology and Inflammation, specifically in atopic dermatitis or alopecia areata is a plus
- Relevant therapeutic area experience is preferred, with late‑stage clinical experience highly desirable
- A PhD, PharmD, or equivalent scientific doctorate is preferred
- Exceptional non-PhDs with demonstrated capabilities and/or equivalent experience may be considered
Benefits
- 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
- 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)
Company Overview