Head of DMPK (Open to Remote)

Location
San Francisco, CA, United States
Posted
Jul 07, 2021
Ref
1151
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
HEAD OF DMPK (OPEN TO REMOTE)

Position Summary:

The Head of DMPK interacts with research and development teams to advance GBT's programs. This position has responsibility to ensure that DMPK assessments for research compounds are conducted to support advancement to development candidates and to progress development candidates to registration in collaboration with colleagues in Clinical Pharmacology and Clinical Sciences. The Head of DMPK is also responsible for overseeing the preparation of DMPK sections of regulatory submissions and serves on project teams.

Essential Duties and Responsibilities:

  • Oversees and is responsible for all DMPK activities at GBT
  • Develops close, collaborative working relationships across functions especially with toxicology, clinical, and pre-clinical pharmacology groups
  • Develops next generation leaders in DMPK
  • Responsible for ensuring collaboration of DMPK team representatives with clinical colleagues to ensure integration of DMPK insights into clinical programs and alignment of nonclinical DMPK and clinical activities related to drug metabolism and pharmacokinetics
  • Ensures adequate DMPK representation on project teams in research and development
  • Collaborates with Research to develop critical pathways to select development candidates
  • Designs and oversees conduct of DMPK studies that support clinical trials and product registration
  • Provides oversight for preparations of DMPK portions of regulatory submissions (IND, NDA, MAA, BLA) and clinical documents (IB)
  • Interacts with regulatory agencies on drug metabolism and pharmacokinetic issues related to development projects
  • Maintains awareness of current and emerging standard practices and guidelines


Qualifications:

  • PhD required. Academic training in drug metabolism, pharmacokinetic or related discipline
  • Experience in the pharmaceutical industry (minimum of 10 years)
  • Ability to work with interdisciplinary teams
  • Communicates in a clear and concise manner to both internal and external stakeholders
  • Excellent organizational and time management skills
  • Experience with managing studies conducted at CROs
  • Experience preparing regulatory submissions and supportive documents
  • History of direct interactions with regulatory agencies (US FDA, EMA)
  • Effectively persuades others and seeks out alternative points of view
  • Seeks to improve oneself and develop others, within and outside direct area of responsibility, to support individual and organizational growth
  • Leverages resources and balances priorities to drive results and achieve business outcomes
  • Works with others towards a common goal and encourages others to perform their best


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.