Director, Clinical Operations

San Francisco, CA, United States
Sep 06, 2018
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Directs all aspects of the clinical operations for identified study(s).

This includes strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical studies and the data collection activities. Establishes and approves (with CRO, Program Leader or Clinical Managers) scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Overall responsibility for adherence to protocols. Interacts with various inside/outside groups to facilitate clinical studies nd programs. May select, develop, and evaluate personnel to ensure the efficient operation of the function.

Contributes to the development and management of Clinical Development Plans (CDP) and Study Plans which include timelines, budget, and resource requirements. Develops and implements clinical study strategy and directs those systems and studies in order to meet Company goals and objectives. Coordinates and directs outsourced activities across study(s). Identifies study/resource gaps; devises and implements solutions. Provides enrollment and study updates to senior management. Drives project risk analysis and develops solutions to a variety of complex problems. Ensures that Clinical Operations department effectively interfaces with key functional groups. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current study(s). Mentors and develops Clinical Operations staff. Directs internal staffing and performance management, including hiring, training, coaching and performance reviews.

A Bachelors/Masters degree in a scientific discipline is required. A PhD in a scientific discipline is preferred. Equivalent experience may be accepted. A minimum of 13 years Pharmaceutical development experience moving product candidates from Phase I through pivotal, with at least 5 years managing CROs is required. A minimum of 10 years previous clinical study management experience is preferred. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is 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.

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.