San Francisco Bay Area
Competitive Salary and Bonus
11 months ago
The Director of Clinical Development, Oncology will be responsible for overseeing the development and management of Clinical Development Plans, including timelines, budget and resource requirements.
Core responsibilities include:
- Design and implement clinical program strategy and direct those systems and programs to meet Company goals and objectives.
- Develop and chair the Medical Advisory Board for proprietary products.
- Participate in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Direct the design of pivotal clinical studies for product and registration.
- Identify and develops collaborations with external investigators and opinion leaders.
- Responsible for interfacing with cross-departmental groups including Clinical Research, Data Management ,Regulatory Affairs, Clinical Operations, Marketing and Business Development.
- Serve as a key clinical opinion leader working with physicians at a peer level.
- Direct and coordinate 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.
- Perform medical monitoring.
- Support the development of publications arising from studies and other relevant initiatives.
- Act as a mentor to junior staff.
- Remain current with medical developments and publications on similar and competitor products.
- Apply this knowledge to current programs.
- May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.
- MD degree is required, Board Certification in oncology is a plus
- 7+ years relevant clinical science/medical affairs experience is required
- Extensive experience in the design of clinical studies in oncology.
- 5+ years previous management experience
- Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Strong 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.