Director/Senior Director, Clinical Pharmacology

Location
92121, San Diego
Salary
Competitive salary and benefits
Posted
Sep 18, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

TP Therapeutics, Inc. (TP) is a clinical-stage structure-based oncology drug design company founded in October 2013 by Dr. J. Jean Cui, the lead inventor of cLdesign and development of novel chemical entities within oncology for established oncogene drivers with high incidence of secondary resistance mutations; newly identified disease-driven targets; and potential targets regulating the tumor microenvironment and tumor immunity. For more information, please visit us at www.tptherapeutics.com.

Director/Senior Director, Clinical Pharmacology

Role Summary

We are seeking a highly motivated individual to join TP Therapeutics as a Director/Senior Director, Clinical Pharmacology, reporting to the SVP, Clinical Operations & Regulatory Affairs, to provide clinical pharmacology strategy on our drug development.  The successful candidate will be a subject matter expert in clinical pharmacology who has experience providing scientific/technical guidance in decision-making. The Director/Senior Director will represent clinical pharmacology on cross-functional teams and will serve as a liaison for information on PK, drug metabolism, toxicokinetics, and bioanalysis within the organization and externally to regulatory authorities and CROs. The individual will maintain knowledge of current GCP, regulatory guidelines and company SOPs and policies and ensure compliance in performing job duties, including those performed by subordinates and/or contractors

Role Responsibilities

  • Major contributor to the scientific/technical aspects of assigned clinical pharmacology studies from conception through final report, including first-in-human, bioavailability/bioequivalence, drug-drug interactions, PK in special population, ADME, and population studies
  • Represent clinical pharmacology on cross-functional teams; identify and communicate potential project hurdles, suggest solutions, and leverage the clinical pharmacology leadership to establish priorities and contingency plans
  • Contribute to regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
  • Collaborate with clinicians, biostatisticians, regulatory affairs, and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes
  • Articulate clinical pharmacology plans and study results to development teams and/or senior management
  • Identify and manage external vendors and consultants supporting the clinical pharmacology function
  • Conduct/supervise NCA PK analyses using WinNonlin software and population PK/PD analyses with NONMEM software
  • Liaise with KOLs and academic collaborators on clinical pharmacology and author/review abstracts/manuscripts generating high-quality presentations/publications

Qualifications

  • PharmD with relevant post-doctoral training in clinical pharmacology, pharmacometrics, or related field
  • 10+ years of relevant industry experience in clinical pharmacology, pharmacometrics, or related discipline(s).
  • Experience in oncology drug development
  • Experience in preparation, submission and response to INDs, NDAs, CTDs, and MAAs
  • Proficient at conducting population PK, PK/PD, PBPK analyses using vendor-based software (Simcyp, GastroPlus, WinNonlin NONMEM, SPLUS, R, etc.)
  • Proven track-record in drug development, clinical pharmacology and pharmacokinetics, and clinical research concepts and practices
  • Strong publication record in the area of clinical ADME/PK coupled with a high level of scientific insight and analytical thinking skills
  • Strong interpersonal and outstanding written and verbal communication skills are essential.  
  • Technical skills including design, execution, analysis and reporting of clinical pharmacology plan.

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.