Note: The job is a remote job and is open to candidates in USA. Nektar Therapeutics is seeking a Senior Director, Clinical Development to provide strategic scientific and medical leadership across clinical development programs. The role leads the design, execution, analysis, and interpretation of Phase I–IV and pivotal clinical trials, ensures regulatory and quality compliance, manages external partnerships, and leads clinical teams.
Responsibilities
- Provide strategic and medical leadership for the design, planning, execution, and interpretation of Phase I–IV clinical trials
- Establish and approve scientific methods for protocol design, implementation of data collection systems, and final clinical reports
- Recruit, select, and manage relationships with clinical investigators and key opinion leaders; negotiate study design and operational parameters
- Oversee medical monitoring, including evaluation and reporting of adverse events, safety data, and clinical risk assessment
- Ensure compliance with FDA and global regulatory requirements, ICH/GCP guidelines, and company standard operating procedures for clinical research and reporting
- Develop and execute Clinical Development Plans (CDPs) aligned with overall program goals, regulatory strategies, and commercial objectives
- Lead the design, conduct, and analysis of pivotal clinical studies supporting registration, labeling, and commercialization
- Establish and maintain external collaborations with academic institutions, contract research organizations, and strategic partners
- Serve as the clinical peer leader and therapeutic-area expert for assigned programs; mentor clinical and medical staff
- Author, review, and contribute to scientific publications, abstracts, presentations, and regulatory submission documents
- Act as a medical liaison and consultant to internal cross-functional teams (Regulatory, Commercial, Safety, Biometrics) and external stakeholders
- Monitor the competitive landscape, scientific trends, and emerging data to inform development strategy and clinical trial design
- Manage, develop, and lead a high-performing clinical team; ensure resource planning, performance management, and operational excellence
Skills
- • MD degree is required
- • Minimum of 9 years of relevant clinical science and/or medical affairs experience in the pharmaceutical, biotechnology, or related industry
- • Demonstrated extensive experience in the design, execution, and analysis of clinical studies
- • Minimum of 7 years of previous management or leadership experience with direct-report accountability
- • Thorough knowledge of ICH/GCP guidelines and FDA/global regulatory requirements governing clinical research
- • Strong strategic thinking, problem-solving, and decision-making skills with demonstrated ability to manage complex clinical programs
- • Excellent written and verbal communication, interpersonal, and presentation skills; proven ability to influence senior management and external stakeholders
- • Senior management experience with cross-functional leadership, team collaboration, and matrixed organizational effectiveness
- • Strong computer skills with proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint
- • Strong strategic thinking, problem-solving, and decision-making skills with demonstrated ability to manage complex clinical programs
- • Excellent written and verbal communication, interpersonal, and presentation skills; proven ability to influence senior management and external stakeholders
- • Senior management experience with cross-functional leadership, team collaboration, and matrixed organizational effectiveness
- • Strong computer skills with proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint
- • Knowledge of GMP/GLP and broader drug development and manufacturing processes
Benefits
- 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.
- 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
Company H1B Sponsorship