Sr. Director, eCOA CLinical Operations

About the Role

The Senior Director, eCOA Management will lead the strategy, governance, and operational execution of electronic Clinical Outcome Assessment (eCOA) capabilities across Nektar’s clinical development portfolio. This leader will set the vision for the eCOA function, establish scalable processes and infrastructure, oversee vendor and CRO performance, and ensure high-quality, inspection-ready delivery of eCOA systems and data across studies and programs.

Responsibilities

• Provide strategic leadership for the eCOA function, including operating model design, process governance, technology strategy, vendor oversight, and talent development.
• Lead, mentor, and develop a high-performing eCOA team; recruit and retain talent while fostering collaboration, accountability, and continuous improvement.
• Drive standardization, automation, innovation, and process improvement to strengthen eCOA delivery and increase clinical development efficiency.
• Develop and implement policies, standards, templates, and best practices related to eCOA design, deployment, data review, and inspection readiness.
• Partner with Clinical Operations, Clinical Development, Biostatistics, Programming, Quality Assurance, IT, and other stakeholders to ensure eCOA strategies support study objectives and regulatory expectations.
• Oversee end-to-end eCOA activities, including protocol review, scale licensing, bibliographic referenced checks against the licenses, review of contracts for copyright/license requirements, communication with cross-functional teams, rater training support, requirements specifications, screen report reviews, user acceptance testing, paper back-up processes, source data review monitoring, data clarification form processing, blinded data analytics, and vendor purchase orders and invoices.
• Evaluate, select, and manage eCOA vendors, platforms, and CRO partners; establish clear expectations, performance metrics, escalation pathways, and governance routines.
• Identify and resolve complex operational, technical, and cross-functional issues; communicate risks, recommendations, and decisions effectively to senior leadership and key stakeholders.
• Ensure eCOA documentation, processes, systems, and data outputs are consistent, compliant, and aligned across studies and programs.
• Maintain inspection readiness and ensure eCOA practices adhere to applicable regulatory requirements and guidelines, including GCP and 21 CFR Part 11.
• Support audits, inspections, and regulatory submissions related to eCOA processes, systems, and clinical trial data.
• Forecast and manage budgets, timelines, resource needs, and external spend with sound judgment and operational discipline.
• Perform other responsibilities as assigned in support of clinical development and company objectives.

Requirements

• Bachelor’s degree in clinical, biological, data, mathematical, or related sciences required; advanced degree and/or PMP certification preferred. Equivalent combination of education and relevant experience may be considered.
• Minimum of 15 years of pharmaceutical, biotechnology, or clinical development experience, including significant experience with eCOA, digital clinical trial solutions, or clinical data systems.
• At least 10 years of line management and project leadership experience, including oversight of service providers and cross-functional teams.
• At least 10 years of vendor management experience in digital clinical solutions, including eCOA vendor selection, contracting, governance, and performance oversight.
• Hands-on experience with eCOA system design, protocol and requirements translation, build documentation review, screen/report review, user acceptance testing, data reconciliation, and query resolution.
• Strong understanding of clinical trial operations, data quality, system validation, GCP, 21 CFR Part 11, and regulatory expectations for electronic clinical outcome assessment systems.
• Experience supporting regulatory inspections, audits, and NDA/BLA submissions preferred.
• Experience in dermatology, including Atopic Dermatitis and/or Alopecia Areata, preferred.
• Experience providing sponsor oversight of CROs and external vendors required.
• Strong ability to lead, communicate, influence, problem-solve, and manage stakeholders effectively in a matrixed environment.

Pay

Nektar currently anticipates the base salary for this role to range from $275,000 to $315,000 for candidates in the Bay Area and will depend on candidate location and qualifications, 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 on company and individual performance and at the Company’s discretion.

Benefits

• 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)