Medical Director - South San Francisco, CA | Biospace
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Medical Director

Global Blood Therapeutics

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Location:
South San Francisco, CA
Posted Date:
11/16/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:
Medical Director, Oncology,

Job Description

Disease program. The GBT440 SCD program encompasses an extensive clinical development program across adult and pediatrics, variant SCD genotypes, and subpopulations with high unmet need. The CTL will have managerial and strategic oversight for one or more clinical teams and will provide medical and scientific leadership to Medical Directors and Clinical Scientists involved in the design, conduct and interpretation of clinical trials to support GBT440 development in SCD. The CTL will represent the clinical development function and provide key strategic input at the SCD product development team.

The CTL will lead one or more Clinical Science Teams (CSTs) who are responsible for developing global Clinical Development (CD) strategies and plans and ensuring effective and efficient CD plan execution. The CTL will guide development of and approve CD strategies, priorities, final interpretation and completion of clinical study results and will interact with the highest levels of management and experts both internally and externally; serving as an internal consultant to other functions (e.g. Business Development) as well as representing the CD strategy, plans, objectives and interests to health authorities and prominent thought leaders. The CTL will provide critical insights and contributions to the overall development and effectiveness of the SCD franchise, including scientific strategies and plans. The position will report to the Clinical Development function head and has the potential to include clinical scientist and medical director direct reports.

Position Responsibilities:
•   Manage the process for the company's clinical studies effort to ensure the highest level of success of clinical protocols, FDA/Health Authority review and successful product launches
•   Direct and oversee clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board/Ethics Committee applications, training, monitoring, documentation and data analysis
•   Review and approve procedures for the design and implementation of clinical protocols, data collection systems and final reports
•   Ensure that all clinical studies are appropriately designed and effectively executed and monitored
•   Provide safety surveillance guidance, acts as a medical monitor and ensures adherence to cGCP requirements and all applicable regulatory references and guidelines
•   Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed
•   Manage outside consultants (consultants, etc.) to ensure data is accurately collected and analyzed in a cost effective fashion
•   Exhibits leadership skills within and outside of the organization (including people skills, mentoring, presentation skills and professional interaction)
•   Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies that are efficient in time and money, and hedge risk as needed.  
•   Review and approve proposals for appropriate personnel assignments, time allocations, and budgets

Requirements

•   M.D. with board certification or eligibility in Hematology/Oncology preferred
•   A proven leader with at least 5+ years of clinical development experience in the biotechnology or pharmaceutical industry, preferably with management experience
•   Demonstrated outstanding leadership of multiple development projects and teams
•   Extensive experience leading the design, conduct, analysis, and reporting of clinical studies, including experience submitting NDAs/BLAs to regulatory authorities in the US and Europe
•   Significant successful interactions with key opinion leaders and investigators
•   An excellent scientific track record demonstrated by publication record in refereed journals
•   Proven ability to effectively work in a cross-functional/matrix environment and successfully leverage internal and external partnerships
•   Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
•   Strategic agility; in-depth knowledge and broad experience in the pharmaceutical or biotech industry and is able to bring this to bear in accomplishing strategic goals and objectives
•   Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions
•   Strong interpersonal, influencing, presentation, and written and verbal communications skills; able to effectively address all levels within an organization
•   Willingness and ability to travel

Fit with GBT culture:
•   Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
•   Ability to build strong relationships with co-workers of various backgrounds and expertise
•   Values-based leadership consistent with GBT's Core Values
•   Excitement about the vision and mission of GBT
•   Flexibility
•   Integrity