Turning Point Therapeutics is seeking a Vice President, Preclinical Development who will be responsible for all aspects of preclinical development in order to advance drug candidates from late stage discovery to the clinic.
This candidate will provide scientific and drug development leadership and responsibility for the execution of IND-enabling studies during preclinical development, internally and externally in all aspects of nonclinical bioanalysis, drug metabolism and pharmacokinetics, and nonclinical toxicology. In addition, the candidate will provide non-clinical support throughout the clinical development up to the NDA application that includes additional toxicology and PK/ADME and metabolism studies in preclinical setting. Responsibilities will include, but are not limited to, timeline management, identification of project risks and contingency planning, preparation of study/program related materials, and supervision of internal activities and CRO study related activities through IND, IND assembly and submission, and NDA submission. This position will report to CSO.
- Participates in key decisions impacting the future of the company in developing and advancing corporate mission and strategic direction.
- Provides leadership to the overall strategic planning and successful implementation of multiple preclinical and development programs up to NDA submission through matrixed program teams.
- Operates as the line manager for a high caliber scientific team responsible for advancing portfolio through late pre-clinical development/translational medicine.
- Plays a critical role in attracting, retaining, grooming, and advancing key players.
- Ensures highest caliber of internal staff and effective network of outside partners, collaborators and service organizations.
- Leads the effort in generating and obtaining consensus on the criteria for nomination of a drug candidate to preclinical development through clinical studies.
- Accountable for the ADME/PK and Toxicology studies to enable nomination of a candidate for preclinical development and for IND submission. Single point of accountability for generating, tracking, and delivering timely, cost-effective and high-quality program milestones and regulatory filings on schedule and budget.
- Participates in the evaluation, selection and management of CROs, contractors, and vendors.
- Manages overall preclinical development operations, project resources, budget and timelines for all assigned programs.
- PhD in Toxicology /Pharmacology or a related discipline is required for this position with at least ten years of development experience and managing preclinical operations.
- Excellent management skills and the ability to lead and inspire high-performance teams.
- Impressive track record of delivering outstanding results including the successful filing of multiple INDs.
- Experienced leader in the transition of discovery programs into clinical development.
- Deep knowledge and strong experience in the evaluation of the PK and safety profile of oncology small molecules.
- Detailed knowledge of the drug development process, Good Laboratory Practices and FDA regulatory requirements.
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 firstname.lastname@example.org