Vice President, Biometrics

Location
San Francisco, CA, United States
Posted
Feb 10, 2021
Ref
958
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
VICE PRESIDENT, BIOMETRICS

Position Summary:

Global Blood Therapeutics is seeking a Vice President of Biometrics to oversee the Biometrics organization with accountability for study designs, data analysis and interpretation of results in collaboration with partner functions in Development and Medical Affairs. The VP provides input into GBT's drug development strategy and assists with regulatory interactions. Acting as a senior member of the Development Leadership Team, the VP of Biometrics will also interact with global Health Authorities, as well as our partner contract research organizations (CRO). The VP of Biometrics will provide biometrics consultations to Business Development, Commercial and Research organizations as needed. The VP is responsible for recruiting, resourcing and building infrastructure for Biometrics to support the GBT portfolio. This position reports to the Chief Medical Officer.

Essential Duties and Responsibilities:

  • Oversees and leads Biometrics input in clinical development plans, clinical protocols, regulatory documents, publications, internal and external meetings and presentations
  • Accountability for development, implementation and execution of statistical analysis plans that support clinical development plans and clinical protocols, and assures statistical integrity, adequacy and accuracy
  • Accountability for the consistency and accuracy of CRO data management and statistical programming deliverables, including derived data definition, analysis files structure, analysis methodologies, and analysis results
  • Represents GBT Biometrics in Health Authority interactions as needed
  • Develops and nurtures key working relationships with internal partners as well as external investigators, research organizations, and thought leaders
  • Continues to build and resource the Biometrics team, mentors and develops members of the Biometrics organization
  • Establishes best practices, identifies the need and drives the creation of functional standard operating procedures


Qualifications:

  • Ph.D. in Biostatistics or Statistics
  • At least 15+ years' industry experience, including line management for at least 7 years; overseeing multiple molecules in development
  • Good Clinical Practice (GCP) proficient
  • Broad and extensive knowledge of theoretical and applied statistics
  • Demonstrated understanding of Phase I - Phase IV drug development
  • Comprehensive understanding of regulatory guidelines for drug development
  • Expert in the principles and techniques of data analysis, interpretation and clinical relevance
  • Expert level of proficiency with SAS and/or other statistical software packages
  • Proven track record of fostering creativity, productivity, execution with a sense of urgency, teamwork, accountability, and cross-functional collaboration
  • Entrepreneurial, self-starter with strong interpersonal and analytical skills, high ethical standards and proven ability to work effectively with cross-functional partners and other internal stakeholders
  • Excellent external networking, relationship and presentation skills and a strong presence
  • Team-builder who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives


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.