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Sr. Director, Clinical Operations

Employer
Nektar Therapeutics
Location
San Francisco, CA, United States
Start date
Apr 26, 2019

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Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Position Overview

The Sr. Director, Clinical Operations will oversee all aspects of the clinical operations for identified program(s).

This includes strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Establishes and approves (with CRO, Program Executive or Clinical Managers) scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May also have responsibility for partnered programs in the areas of supply training, labeling, package design & pulmonary drug development. Overall responsibility for adherence to protocols. Interacts with various inside/outside groups to facilitate clinical programs. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

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. 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 those systems and programs in order to meet Company goals and objectives. Coordinates and directs outsourcing activities across program(s). Creates and directs program advisory committees as needed, such as Program Advisory Committee, DSMB and/or expert consultants. Identifies program/resource gaps; devises and implements solutions. Provides weekly enrollment and program 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 programs. 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 15 years Pharmaceutical development experience moving product candidates from Phase I through pivotal, with at least 8 years managing CROs is required. A minimum of 12 years previous management experience may be required. 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.

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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