Senior Director/Executive Director, Clinical Research- CA

The primary responsibility is to provide medical guidance, medical review, analysis and data interpretation from clinical studies.  This individual will act as the primary Medical Monitor and oversee the safety of clinical programs. In addition, provide scientific support to the Clinical Development team in the development of various oncology and hematology projects.

Responsibilities:

• Acts as a medical resource to the company as a whole including: the Clinical Development department, discussions with investigators, internal meetings, etc.
• Develops and maintains relationships with key opinion leaders, collaborating researchers, research sites, and academic thought leaders to optimize clinical trial strategies and clinically manage the behavior of the clinical trials
• Responsible for Medical Monitoring of clinical development studies
• Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards
• Write and review clinical trial protocols that are in line with the overall indication strategy
• Review risk assessments, as well as regular reviews of safety and clinical trial data.
• Oversees the preparation of IND Safety updates, investigator communications, and other reports as necessary.
• Collaborate with various departments for preparation of clinical development plans, protocols, IB’s, study reports, and presentations.
• •Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, clinical sections of INDs, IB’s
• Scientific conference presentations
• Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents and ensure the scientific accuracy of documents/presentations.
• Ensure compliance with FDA, ICH, EMEA, and GCP guidelines

Qualifications:

• M.D. degree; oncologist or hematologist
• Board certification and current US medical license preferred
• 8+ years’ clinical research experience
• Solid oncology/hematology KOL relationships
• Deep understanding of clinical practices, regulatory  regulations,  and FDA interactions with a track record of drug approvals
• Exceptional leadership / mentoring abilities
• Strong verbal and written communication, problem prevention/solving skills

• Good interpersonal skills and ability to lead and work with co-workers and outside agencies professionally and tactfully.

• Strong analytical ability to exercise judgment in developing methods and criteria for determining appropriate action to obtain objectives.