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
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.
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
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.
Internal Number: DSDCP
About TP Therapeutics
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 Pfizer’s oncology drug crizotinib and lorlatinib. The TP team is focused on the design 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.