Sr. Director Clinical Pharmacology

BACK

Rain Therapeutics is committed to building a passionate team of core business leaders to implement our vision to identify and execute on the development of novel therapeutic avenues for the treatment of cancer.  The personality of Rain will always be focused on entrepreneurs with autonomy to build their respective teams in a flat organizational structure.

Rain Therapeutics Inc. is a privately held biotechnology company developing targeted therapies for patients with cancer. Rain’s objective is to identify cancers with clear and identifiable genetic vulnerabilities and evaluate sub-populations of cancer populations with an unmet need, where standards of care are ineffective. Our lead program is RAIN-32, a small molecule MDM2 inhibitor for patients with well-differentiated and de-differentiated liposarcoma, and other indications exhibiting MDM2 gene amplification or overexpression. RAIN-32 has completed clinical trials in certain solid tumors and hematological malignancies and has received FDA Orphan Drug Designation for patients with liposarcoma.

Tarloxotinib, a hypoxia-activated pan-HER inhibitor is in clinical trials for patients with HER2 activating mutations in non-small cell lung cancer, as well as a tumor-agnostic cohort for patients with NRG1, EGFR, HER2, and HER4 fusions. Rain is also developing a potential first-in-class inhibitor of RAD52 in the DNA Damage Response (DDR) pathway as a synthetic lethal strategy for tumors with BRCA1/2 mutations.  The Senior Director, Clinical Pharmacology will be an integral member of the multidisciplinary team and is responsible for leading the near-term clinical pharmacology studies required for RAIN-32 and provide support across the entirety of the therapeutic pipeline.  We are seeking a highly motivated individual to join Rain Therapeutics as Clinical Pharmacology lead (Director to Sr. Director level). The Senior Director will report to the Chief Medical Officer / SVP of Clinical Development, with dotted line reporting to the VP, Clinical Operations and to the VP, Biology and Non-Clinical Operations.

Key Requirements:

  • A Pharm. D., or Ph.D. degree in relevant disciplines with 10+ years of industrial experience as a clinical pharmacologist. The level will be depending on experience
  • Extensive experience in formulating and executing clinical development strategies including design, interpretation and reporting of clinical pharmacology studies and PK-PD modeling and simulations is required
  • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required
  • Experience in preparation of clinical pharmacology section in NDA/sNDA/BLA
  • Specific experience in designing and managing drug-drug interaction (DDI) studies and 14C AME studies is required; experience with thorough QT (TQT) studies is highly preferred
  • Innovative thinking and approach to increase the probability of successful rate with less cost
  • Record of successful publications in the area of clinical pharmacology and pharmacometrics

Position Description

  • Represent clinical pharmacology discipline on cross-functional project teams involving the clinical development of candidate drug products
  • Collaborate with biostatisticians, clinicians, and clinical operations colleagues for the optimal design of Phase I-III studies
  • Assist in integrating and interpreting nonclinical and clinical pharmacology, DMPK, and translational medicine knowledge; lead modeling & simulation (PK/PD) activities in the clinical and clinical pharmacology programs
  • Develop clinical pharmacology plans (e.g. assessment of QT, DDI strategy, special populations, etc), design and direct clinical pharmacology studies, and work cross-functionally to develop clinical protocols
  • Provide scientific leadership in the preparation, conduct and reporting of clinical pharmacology studies
  • Integrate and interpret clinical pharmacology data and quantitative translational knowledge to prepare the clinical pharmacology section of regulatory documents (IND, IMPD, IB, NDA CTD) Prepares responses to inquiries from regulatory agencies
  • Work with clinical pharmacology leadership to identify areas and questions where advanced modeling may add value and work with collaborators to ensure right approach and tools are used. Works closely with advanced modeling and simulation colleagues to ensure strategic integration of advanced modeling and simulation approaches (e.g., QSP, MBMA) across the development continuum to inform internal decisions and external regulatory interactions
  • Participate in writing publications and making scientific presentations consistent with development strategies and publication plan
  • Directs the review of preclinical pharmacology program to ensure that sufficient data exist for clinical development.

Preferred Qualifications

  • Track record of contribution to project teams enabling achievement of milestones in a time-efficient manner
  • Demonstrated hands-on experience and good knowledge across a range of modelling techniques
  • Ability to develop successful relationships with, and influence internal and external customers
  • Completes assigned work in a resourceful, self-sufficient manner and will create alternative approaches to achieve desired results when necessary
  • Demonstrated scientific and technical expertise through publications, patents, awards/honors or credibility at professional societies
  • Excellent written, communication, technical presentation skills

Rain Therapeutics is an equal opportunity employer, and we are proud of our ongoing efforts to foster diversity & inclusion in the workplace. Individuals seeking employment at Rain are considered without regard to race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, physical or mental disability, military or veteran status, or any other characteristic protected by applicable law.