Associate Director, Compliance Clinical Operations

Location
San Francisco, CA, United States
Posted
Jul 12, 2021
Ref
5372-530-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Exciting Opportunity to join the Clinical Operations team at Nektar.

Identifies, develops, and executes quality and compliance strategies and initiatives across the Clinical Operations organization. Leads quality initiatives. Identifies and mitigates risk and provides input to senior management. Maintains tools and materials that are essential to the execution of quality management systems. Provides leadership and expertise necessary to advance the vision of the department. Liaises cross-functionally and gains cross-functional support and feedback, as required. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilties:
  • Works on complex problems or data requires an in-depth evaluation of various factors. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedule, work plans, and performance requirements.
  • Serves on Cross Functional SOP Working Group
  • Authors updates and/or new departmental SOPs and Work Instructions
  • Performs review of cross-functional SOPs and Work Instructions on behalf of Clinical Operations as needed
  • Supports inspection readiness through development of materials, participation in storyboard creation/review, and serves as a critical member of Inspection Readiness Teams
  • Engages with a variety of cross-departmental staff to conduct Gap analysis.
  • Ensures appropriate compliance with plans and procedures (e.g. quality events, planned deviations, inspection preparation, site and vendor audits, vendor oversight).
  • Leads and tracks Quarterly Operational Reviews
  • Identifies and mitigates risk through participation in risk management activities and/or the compilation and analysis of metrics and trends and provides input to senior management.
  • Develops and maintains tools which facilitate the compliance within the defined quality management systems.
  • Mentors less experienced staff and serves as a team lead for group projects.
  • Leads process/compliance improvement projects and initiatives
  • Serves as consultant and spokesperson for the functional area across multiple departments.
  • Creates formal networks internally and externally involving coordination among groups.
  • Other duties as assigned.
Requirements:
  • A Bachelor's degree in a scientific discipline is required. Higher degree preferred. Equivalent experience may be accepted.
  • A minimum of 10 years Pharmaceutical development experience with at least 4 years managing compliance/audit activities required. 8+ years of management experience preferred.
  • Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
  • Excellent written and verbal communication skills are required.
  • Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred.
  • Must be a demonstrated self-starter and team player with strong interpersonal skills.
  • Must possess excellent project management skills.
  • Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint.
  • Serves as consultant and spokesperson for the functional area on highly significant matters relating to operations, scheduling or specific phases of project or contracts.
  • Creates formal networks involving coordination among groups.


We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.