Exec Medical Director
Proclinical is currently recruiting for an Executive Director of Clinical Development (MD) with a biopharmaceutical company located in San Francisco, CA. Successful candidate will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
- May recruit clinical investigators and negotiate study design and costs.
- Responsible for directing human clinical trials, phases I through IV for company products under development.
- Adverse event reporting and safety responsibilities monitoring.
- Coordinate and develop 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.
- Oversee the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements.
- Ensure 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.
- Drive the development of publications arising from studies and other relevant initiatives. Act as a mentor to junior staff.
Skills and Requirements:
- Bachelor's degree in a scientific discipline is required. MD degree is also required.
- 15+ years' relevant clinical science/medical affairs experience is required. A minimum of 8 years previous management experience may be required.
- Must be able to demonstrate extensive experience in the design of clinical studies. 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 about 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call James Stevens at (+1) 646-693-0610 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.