Associate Director / Director, DMPK

About Us :

Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation.

Together, we are working to advance first-in-class targeted cancer medicines that can provide better and more durable outcomes for patients, particularly where drug resistance is observed.

Partnering together in a supportive, open, and collaborative environment, we share a sense of purpose and urgency and commitment to patients to approach cancer biology through a different perspective and to establish Activation Lethality as the next wave of oncology therapeutics.

The Difference You’ll Make

Delphia is searching for an Associate Director / Director, Drug Metabolism and Pharmacokinetics to join the team! The Associate Director / Director, DMPK will provide scientific leadership and strategic direction for all DMPK activities on discovery and development programs.

This individual will collaborate closely with the chemistry, biology, toxicology and future translational pharmacology and clinical development teams to design and implement studies to address key program DMPK questions and to provide strategic direction.

What You’ll Do :

• Provide the internal DMPK expertise and set and implement DMPK strategy across Delphia’s discovery portfolio leading DMPK efforts organizationally as the first group hire.
• Manage non-clinical ADME studies spanning discovery research to early clinical development.
• Act as the DMPK lead on project teams providing clear strategic direction in the area of DMPK; organize maintain and present research data at the project team level.
• Plan, analyze, and interpret DMPK studies to support program goals and objectives.
• Work collaboratively with the toxicology team and future translational pharmacology and clinical development teams to support the progression of therapies from late discovery through first in human clinical studies integrating DMPK data into the overall drug development strategy.
• Conduct PK / PD modeling using non-compartmental and compartmental models.
• Guarantee the timely completion and high-quality review of DMPK reports, including BA and TK reports from nGLP and GLP toxicology studies.,
• Prepare regulatory submission documentation, author DMPK sections of regulatory documents.
• Identify and manage consultants and vendors for additional support in ADME, PK, and PK / PD study execution and analysis as needed.

What You Bring :

• PhD in relevant scientific field with 7-10+ years of experience in bio / pharmaceutical industry
• Technical depth and a broad understanding of small molecule DMPK
• Extensive knowledge of drug metabolism, bioanalysis, pharmacokinetics, preclinical pharmacology, PK / PD modeling, and clinical study designs.
• Demonstrate innovative thinking driving toward cutting-edge approaches.
• Proactive at solving complex problems within a collaborative, fast-paced, matrixed team environment.
• Experience and proficiency in managing activities at CROS as well as managing GLP and regulated activities.
• Experience leading DMPK on projects particularly in discovery and early development.
• Operational experience and familiarity with the drug discovery and development process.
• Ability to operate objectively and independently as a leader and as a member of a team.
• Excellent verbal and written communication skills for effective collaboration and presentation of data.
• Comfort operating in complexity and ambiguity in a fast-paced environment interacting with consultants, external vendors, and internal cross-functional teams.
30+ days ago