Director, Clinical Development (MD)

Location
San Francisco, CA, United States
Posted
Oct 19, 2018
Ref
3294-515-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

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. Responsible for the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements. Develops and implements 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. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Directs 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, Data Management ,Regulatory Affairs, Clinical Operations, Marketing and Business Development. Acts as a clinical opinion leader working with physicians at a peer level. Directs and coordinates efforts to address medical and scientific issues. Works closely with Data Management and Biostatics to provide clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products. Provides support to the business in the review of promotional materials and the training of product representatives. Performs medical monitoring. Supports 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 7 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 5 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 possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint. Must be willing to travel.

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.