Medical Director - Clinical Development
Proclinical is currently recruiting for a Director, Clinical Development (MD) with a biopharmaceutical company located in San Francisco, CA. Successful candidate will oversee 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.
- Responsible for the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements.
- Develop and implement clinical program strategy and directs those systems and programs in order to meet Company goals and objectives.
- Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Identify and develop collaborations with external investigators and opinion leaders.
- Work closely with groups such as, Clinical Research, Data Management, Regulatory Affairs, Clinical Operations, Marketing and Business Development.
- Act as a clinical opinion leader working with physicians at a peer level. Directs and coordinates efforts to address medical and scientific issues.
- Work closely with Data Management and Biostatics to provide clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products.
- Provide support to the business in the review of promotional materials and the training of product representatives.
- Support the development of publications arising from studies and other relevant initiatives. Acts as a mentor to junior staff.
- Remain current with medical developments and publications on similar and competitor products.
- May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews
Skills and Requirements:
- Bachelor's degree in a scientific discipline is required. MD degree is also required.
- 7+ years relevant clinical science/medical affairs experience is required A minimum of 5 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 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.
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.