Medical Director, Clinical Development

Location
San Francisco, CA, United States
Posted
Dec 02, 2018
Ref
365
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
MEDICAL DIRECTOR, CLINICAL DEVELOPMENT

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.

Position Summary:
  • 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

Essential Duties and Responsibilities:

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.