Provide strategic scientific and medical leadership across the direction, planning, execution, and interpretation of clinical trials and research data collection activities. Establish and approve scientific methods for protocol design, data collection systems, and final reports, ensuring high-quality clinical research that supports pharmaceutical and biotechnology pipeline development.
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.
Qualifications
- 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.
Required Skills
- 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.
Preferred Skills
- Knowledge of GMP/GLP and broader drug development and manufacturing processes.
Pay range and compensation package
Nektar currently anticipates the base salary for the Senior Director, Clinical Development (MD) to range from $280,000 to $330,000 for candidates 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.
About the Company
Nektar currently anticipates the base salary for the Senior Director, Clinical Development (MD) to range from $280,000 to $330,000 for candidates 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.
Equal Opportunity Statement
Nektar is committed to diversity and inclusivity in the workplace.