San Francisco Bay Area
Competitive Salary and Bonus
about 1 year 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.