Executive Director, Clinical Development (MD)

San Francisco, CA, United States
Jul 18, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

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

A senior leader, overseeing 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 through 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. Overall responsibility for 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.

Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, 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 critical matters. Influences policymaking. 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. May create and chair the Medical Advisory Board for proprietary products. Oversees the design of pivotal clinical studies for product and registration. Identifies and develops collaborations with external investigators and opinion leaders. Responsible for working closely with groups such as, Clinical Research, Regulatory Affairs, Clinical Operations, Marketing and Business Development. Acts as a clinical opinion leader working with physicians at a peer level. Oversees and coordinates efforts to address medical and scientific issues. Provides clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products. Provides guidance to the business in the development of promotional materials and the training of product representatives. Oversees and performs medical monitoring. Drives the development of publications arising from studies and other relevant initiatives. Acts as a mentor to junior staff. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.

A minimum of a Bachelors degree in a scientific discipline is required. An MD degree is also required. A minimum of 15 years relevant clinical science/medical affairs experience is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 8 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 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 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 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 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.