Medical Director, Clinical Development

Global Blood Therapeutics, Inc. (GBT) - South San Francisco, CA

Full-timeEstimated: $150,000 - $200,000 a year
EducationSkills
Position Summary:
Global Blood Therapeutics is looking for an experienced physician, leader and innovative drug developer with passion and creativity and who places the patient at the center of everything they do.

The individual will be a self-starter with excellent leadership, communication (within and outside of the organization) and multi-tasking skills. They should have a strong experience with clinical study conduct, data analysis and health authority document preparation and interactions. This position will also afford the individual the opportunity for increasingly more responsibility and leadership roles encompassing strategic planning, broad portfolio product development and personnel management within the Clinical Development team.

Essential Duties and Responsibilities:
Clinical Lead for the Sickle Cell Disease Program clinical studies including adult and pediatric programs
Clinical point of contact for all study related matters including data gathering, analysis and interpretation, safety assessments, regulatory documentation and publications
Clinical lead for development and execution of Clinical Development (CD) plans for the SCD program and including contributing to scientific, clinical and publication planning
Clinical lead in communications to senior management and governance committees on study progress and strategic updates
Perform responsibilities independently and exhibit proficiency of the Medical Director role
Support Health Authority document review and interactions
Support Business Development efforts
Clinical leadership of other pipeline molecules as needed
Cross-Functional Team and People Management
Participate in Study Execution Team (SET) Meetings and represent Clinical Science in program sub-teams
Provide clinical leadership to support the training and monitoring of study sites.
Review and provide guidance on appropriate personnel assignments and budgets
Where applicable, hiring, retaining and managing direct reports and clinical consultants
Clinical Development Planning
Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies
Stay abreast of internal and external clinical and SCD landscape developments and update Clinical Development functions
Participate in Health authority document preparation and interactions
Provide clinical input into the relevant therapeutic/disease area scientific strategy
Provide clinical input for transitioning new drugs/indications into clinical development
Clinical Development Plan Implementation
Provide clinical oversight of relevant studies and progress, including participation in Study Execution Team meetings, reviews of medical/safety data, CSR writing
Provide clinical leadership for study site interactions, fielding medical questions and conducting Investigator Meetings
Represents GBT through collaborations with internal and external partners such as investigators, clinicians, scientists and key opinion leaders
Collaborate with Statistics to ensures appropriate medical/scientific data interpretation for study reporting and health authority interactions
Lead, or otherwise develops and provides, clinical science input into annual and strategic lifecycle plans

Qualifications:
Demonstrated proficiency in the Medical Director role
MD degree or MD, PhD degrees
4+ years of drug development experience
Must be board certified in medicine; optimally in hematology and/or pediatrics
Experience in writing and submission of Health Authority documents including IND and desirably NDA and pediatric investigational plans
Have strong cross-functional team leadership skills
Ability to work independently and in a fast paced, hands-on, growth-oriented work environment

Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise
Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
Values-based leadership consistent with GBT's Core Values
Excitement about the vision and mission of GBT
Flexibility
Integrity
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.