Director, Clinical Development (MD)

Location
San Francisco, CA, United States
Posted
Jun 05, 2021
Ref
5304-515-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Director, Clinical Development (MD) to join their team.

Summary:

Oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases I-IV for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements. May select, develop, and evaluate personnel to ensure the efficient operation of the function.

Essential Duties and Responsibilities:

Manage medical monitoring plans, site interactions, and reviewing data output from ongoing clinical studies and safety reviews. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Responsible for working closely with groups such as, Regulatory Affairs, Clinical Operations, Marketing and Business Development. Assist in communicating a clear overview of ongoing trial results to both internal and external stakeholders. Provide organizational support for Data Monitoring Committees and other applicable data review committees, including preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports. Support clinical trial objectives; responds to or triages questions for appropriate escalation. Act as recognized clinical expert for assigned studies both within and external to Nektar. Identifies and develops collaborations with external investigators and opinion leaders. Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the study team and external collaborators. Collaborate on the preparation of scientific material for conference presentations or publications. Responsible for the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements. Provides clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products. Acts as a mentor to junior staff. May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.

Minimum Qualification Requirements:

MD degree with a minimum of 7 years relevant experience is required. Must be able to demonstrate extensive experience in the design and conduct of heme-oncology clinical studies. Must be able to communicate (written and orally) clinical and scientific data to a variety of audiences. Experience in conducting formal presentations to Sr. Management and key opinion leaders in required. Must have knowledge of effective competitive strategies as well as an in-depth understanding of oncology clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Experience and understanding of biostatistics, Good Clinical Practices, ICH, and other regulatory requirements for clinical studies is required. 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.