Competitive Salary and Bonus
about 1 year ago
The Sr. Director, Clinical Development - Oncology (MD) oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities.
- MD degree is required, Board Certification in oncology or related field is a plus.
- 9+ years relevant clinical science/medical affairs experience in oncology is required
- Extensive experience in clinical study design in oncology is required
- 7+ years previous management experience may be required.
- Strong ability and desire to solve problems with innovative solutions along with strong organizational skills.
- Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
- Extensive experience and understanding of ICH, and GCP is required, knowledge of GMP and GLP is preferred.
Core responsibilities include:
- Create and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
- Recruit clinical investigators and negotiate study design and costs
- Oversee human clinical trials, phases I-IV for company products under development
- Responsibilities also include adverse event reporting and safety responsibilities monitoring.
- Coordinate and develop reporting information for reports submitted to the FDA.
- Ensure adherence to protocols and determine study completion.
- Act as consultant/liaison with other corporations when working under licensing agreements.
- Select, develop, and evaluate personnel to ensure the efficient operation of the function.
- Collaborate on abstract problems across functional areas of clinical development and medical affairs.
- Identify and evaluate fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products.
- Interact internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies.
- Oversee the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements.
- Ensure development and implementation of clinical program strategy and direct those systems and programs to meet Company goals and objectives.
- Create and chair the Medical Advisory Board for proprietary products.
- Oversee the design of pivotal clinical studies for product and registration.
- Identify and develop collaborations with external investigators and opinion leaders.
- Collaborate with cross-departmental teams as, Clinical Research, Regulatory Affairs, Clinical Operations, Marketing and Business Development.
- Act as a clinical opinion leader working with physicians at a peer level.
- Oversee and coordinate efforts to address medical and scientific issues.
- Provide clinical analysis, scientific and clinical support for expansion of market share of Company products.
- Provide guidance to the business in the development of promotional materials and the training of product representatives.
- Oversee and perform medical monitoring.
- Drive 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.
- May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews.