The company is dedicated to discovering and developing groundbreaking therapies to revolutionize cancer treatment. Our team, consisting of experienced leadership and a renowned scientific founder, focuses on translating innovative research into new therapeutic solutions. With a strong history in drug discovery and development, we have been instrumental in the creation of several clinical-stage compounds and an approved drug for the treatment of cancer and immune-mediated inflammatory diseases.
Key Responsibilities:
- Lead DMPK efforts in support of drug discovery and early development for small molecules, working closely with the biology and chemistry teams.
- Report to the Executive Director of Preclinical R&D, collaborating with multifunctional teams across DMPK, biology, and chemistry to advance projects from discovery through early clinical development.
- Provide scientific expertise in DMPK assays and their application to solve broader project challenges, ensuring alignment with overall drug development goals.
- Represent DMPK on multiple cross-functional project teams, contributing to decision-making and project strategies.
- Mentor and train junior members of the DMPK team, fostering professional development and knowledge sharing.
- Manage in-vivo and in-vitro ADME/PK studies, ensuring timely and accurate data generation to support drug discovery efforts.
- Prepare and review the nonclinical sections of regulatory submissions, contributing to IND/CTA filings and other regulatory documentation.
- Oversee the contracting and management of CROs for nonclinical studies, ensuring high-quality deliverables.
- Demonstrate leadership in driving DMPK initiatives, maintaining strong organizational and reporting skills to meet project milestones.
Qualifications:
- Significant experience in a leadership role within a multifunctional DMPK group at a pharmaceutical company.
- Proven ability to manage and oversee ADME/PK studies and provide technical leadership across multiple projects.
- Extensive knowledge of DMPK assays, with a strong understanding of their application to drug development challenges.
- Experience in writing and reviewing nonclinical regulatory submissions, with familiarity in managing CRO relationships for nonclinical studies.
- Highly motivated, with excellent organizational, communication, and mentoring skills.
