Director, Pharmacovigilance/Safety MD

ROLE SUMMARY

TP Therapeutics is seeking a Director/Senior Director of DMPK who will be an integral member of a team responsible for characterizing the DMPK properties of these transformative cancer medicines both in vitro and in vivo. This position reports to the SVP of Pre-clinical Development.

ROLE RESPONSIBILITIES

  • Leadership in preclinical and early clinical studies, including but not limited to in vitro and in vivo ADME assays, PK/TK support, M&S.
  • Representing DMPK function in cross functional project team and provide critical feedbacks to project teams from DMPK point of view.
  • Leading regulatory related activities in DMPK areas for R&D and generating and reviewing documents such as investigator’s brochures, INDs & CTAs, and providing scientific support on all licensing activities.
  • Managing collaborations with CRO/CMO for outsourcing activities.
  • Ensuring reporting timelines for all DMPK related reports. Expected to review, edit, and offer critical feedbacks to the reports generated by CROs.

QUALIFICATIONS

  • Ph.D. degree in relevant discipline with 10+ years of industrial experience with 3+ years of experience as project leader or project representative.
  • Experience managing DMPK CROs.
  • Experience with preparation of regulatory documents, such as IND, CTA, NDA, etc.
  • Broad background knowledge in DMPK with strong expertise in PK, drug metabolism.
  • Ability to perform modeling & simulation.
  • Working knowledge of DMPK related regulations and regulatory guidelines from ICH, FDA and EMA.
  • Track record of contribution to project teams enabling achievement of milestones in a time efficient manner.
  • Excellent communication, presentation skills, and attention to detail.

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com