Director, Clinical Development (MD)

Location
San Francisco, CA, United States
Posted
Oct 27, 2018
Ref
3386-515-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Participates in the direction, planning, execution, and interpretation of clinical trials in phases I through IV and the data collection activities associated with these trials.

Collaborates in the design and implementation of clinical protocols, data collection systems and final reports. May help recruit clinical investigators and negotiate study design and costs. Responsibilities also include monitoring adverse event reports and surveilling for safety trends among clinical trial data. Aids in data review, interpretation, and presentation for reports submitted to the FDA. Monitors sponsor and clinical site adherence to protocols. May act as consultant/liaison with other corporations when working under licensing agreements. May select, develop, and evaluate personnel assigned to clinical trial teams to ensure efficient operation of the function.

May contribute to the development and management of Clinical Development Plans (CDP), including timelines, budget, and resource requirements. Identifies and develops collaborations with external investigators and opinion leaders. Responsible for working closely with groups such as Non-Clinical Research, Regulatory Affairs, Clinical Operations, Manufacturing, Biostatistics, Marketing, and Business Development. Acts as one of the sponsor's clinical opinion leaders working with external physicians at a peer level. Provides support to the business in the development of promotional materials and the training of product representatives. Performs clinical trial medical monitoring. Supports the development of publications arising from studies and other initiatives. Acts as a mentor to junior staff. Remains current with medical developments and publications on similar and competitor products and applies this knowledge strategically to current internal programs. May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.

A Bachelors degree and and MD degree are required. A minimum of 7 years of relevant clinical development and/or medical affairs experience is required. Must be able to demonstrate extensive experience in the design, development, and writing of clinical studies. A minimum of 5 years' previous management experience may be required. Must have a demonstrated ability to solve clinical development problems with innovative solutions as well as possess strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with and conducting formal presentations to senior management and key opinion leaders is required. Must have knowledge of effective competitive clinical development 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 independent contributor, and be a team player with strong interpersonal skills. Must possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Word, Excel, 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.