Department/Group: Clinical Development
Location: Burlingame, CA
Position Type: Full time
Role and Responsibilities
- Oversees the direction, planning, execution and interpretation of clinical trials/research and data collection activities
- In collaboration with Biometrics function, writing and implementation of clinical protocols, data collection systems and final reports
- May recruit clinical investigators and negotiate study design and costs
- Help organize and coordinate advisory boards and investigator meetings
- Responsible for directing human clinical trials, phases I – III, for company products under development including Medical Monitor responsibilities
- Responsibilities also include adverse event reporting and safety responsibilities monitoring
- Coordinates and develops information for reports submitted to the FDA
- Monitors adherence to protocols and determines study completion
- May act as consultant/liaison with other corporations when working under licensing agreements
- Selects, develops and evaluates personnel to ensure the efficient operation of the function
- Works with other senior managers to establish strategic plans and objectives
- Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people
- Ensures that budgets and schedules meet corporate timelines
- Must have strong negotiation skills with vendors and management in order to influence senior leaders regarding matters of significance to the organization
- Directs and controls the activities of a broad functional area through partnership with cross-functional department managers within the company
Qualifications and Education Requirements
- MD required
- Completion of Fellowship in Hematology/Oncology
- 5+ years of biotech industry experience required including experience within Hematology/Oncology therapeutic indications
- Excellent teamwork and collaboration skills
- Proficient with Microsoft Office.
- Able to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, transparency, and drive.