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Nektar Therapeutics

    Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and oth... Read More

Address      455 Mission Bay Boulevard South San Francisco, CA 94158
Website      www.nektar.com/
Holding      No Holding Details

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Clinical Operations

Manages and maintains the relationships with the expert outsourced consultants or in-house Clinical Research Associates (CRAs). This involves evaluating and analyzing tools and processes to support consultant efforts. Maintains a high level of professional expertise through familiarity with clinical literature. Typically travels to field sites to supervise and coordinate clinical studies, by monitoring schedules, and clinical evaluation projects. May select, develop, and evaluate personnel to ensure the efficient operation of the function.

Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques. Participates in the implementation, day-to-day organization, management and execution of the Clinical Development Plan which includes budget and resource requirements. Projects and coordinates study supply and packaging requirements. Coordinates site training and protocol implementation for partnered programs. Act as the clinical resource for the internal development team. Projects and coordinates study supply and packaging requirements. Manages out sourced activities for clinical studies, such as CROs, bio-analytical labs, and site monitoring to ensure adherence to timelines and protocol requirements. Manages expert consultant activities for study related activities, including effective communication. Identifies program/resource gaps and proposes solutions. Provides weekly enrollment and program updates to senior manager. May manage internal staffing and performance management, including hiring, training, coaching and performance reviews. May mentor and develop junior clinical operations staff.

A Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years Pharmaceutical development experience with at least 2 years managing CROs is required. A minimum of 5 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills.

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Vacancy type:

Full Time

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Contact Name:

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Job Duration:

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