Sr Director, Clinical Operations

The Sr Director, Clinical Operations oversees all aspects of clinical operations for assigned programs. This role provides strategic and operational leadership for planning, execution, interpretation, and data collection in clinical programs. The incumbent collaborates with CROs, Program Executives, and Clinical Managers to establish and approve scientific methods for protocol design, data collection, and reporting, ensuring adherence to protocols. The Sr Director interacts with various internal and external groups to facilitate clinical programs and is responsible for talent selection, development, and evaluation to ensure functional efficiency. This position contributes to and supports the company''s research and development efforts to create high-value therapeutics to address unmet medical needs.

Key Responsibilities

Strategic Leadership & Planning

• Consistently works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas. Interacts internally and externally with executive-level management, requiring negotiation of extremely difficult matters to influence policymaking bodies.

Clinical Development

• Oversees the development and management of Clinical Development Plans (CDP), which includes timelines, budget, and resource requirements. Ensures the development and implementation of clinical program strategy and directs systems and programs in order to meet Company objectives.

Outsourcing & Resource Management

• Coordinates and directs outsourcing activities across program(s). Identifies program and resource gaps; devises and implements solutions. Provides weekly enrollment and program updates to Senior Management.

Risk Management & Problem Solving

• Drives project risk analysis and develops solutions to a variety of complex problems. Ensures that the Clinical Operations department effectively interfaces with key functional groups.

Team Leadership & Development

• Mentors and develops Clinical Operations staff. Directs internal staffing and performance management, including hiring, training, coaching, and performance reviews. Remains current with medical developments and publications on similar and competitor products, applying this knowledge to current programs.

Required Qualifications

• Education: A Bachelor''s or Master''s degree in a scientific discipline is required. Equivalent experience may be considered.
• Experience: A minimum of 15 years of pharmaceutical development experience moving product candidates from Phase I through pivotal trials, with at least 8 years managing CROs, is required. Experience managing and executing global clinical programs is required. A minimum of 12 years of previous management experience is required.

Skills & Competencies

• Demonstrated ability to solve problems with innovative solutions and strong organizational skills.
• Excellent written and verbal communication skills; experience working with senior management.
• Experience with, and understanding of, ICH and GCP is required; knowledge of GMP and GLP is preferred.
• Demonstrated ability to work independently and collaboratively, with strong interpersonal skills.
• Excellent project management capabilities.
• Proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint is required.
• Preferred: Experience with oversight of a large CRO on a Phase III program.
• Preferred: Experience in Atopic Dermatitis and/or Alopecia Areata or related therapeutic indications.
• People management and cross-functional management experience highly preferred.

Travel Requirements

The employee may be required to travel up to 25% of the time within the U.S. and internationally. Attendance at meetings and congresses on weekends may be required.

Additional Information

Nektar currently anticipates the base salary for the Sr Director, Clinical Operations to range from $300,000 to $350,000 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.