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Director of DMPK/Clinical Pharmacology

Entos

Entos

San Diego, CA, USA
Posted on Tuesday, March 12, 2024

JOB SUMMARY

Lead the DMPK/Clinical Pharmacology efforts at Iambic, setting clear objectives and overseeing performance. Design and implement strategies for DMPK studies. Oversee ADME/PK studies to support drug discovery and preclinical/clinical drug development. Collaborate with internal and external partners to plan and execute DMPK studies. This role will support both research and clinical efforts and is based at the San Diego headquarters.

KEY RESPONSIBILITIES

  • Lead and manage all internal and external DMPK and clinical pharmacology activities, design and implement DMPK strategies to support discovery and development programs.
  • Provide scientific leadership and expertise to internal cross-functional teams, ensuring alignment with overall drug discovery/development goals.
  • Oversee non-clinical ADME/PK and PK/PD studies, manage CRO and collaboration with external experts to supplement internal capabilities.
  • Support regulatory submissions (INDs, NDAs) by providing DMPK and clinical pharmacology data, report and expertise.
  • Stay current with the latest advancements in DMPK, clinical pharmacology, and regulatory guidelines.
  • Ensure compliance with industry regulations and standards in all DMPK activities.
  • Participate in due diligence and business development activities as needed.

QUALIFICATIONS

  • PhD in relevant field such as Pharmacology, Biochemistry, Chemistry, Biology or related discipline
  • At least 10 years of experience in the pharmaceutical or biotechnology industry, with a focus on DMPK and or clinical pharmacology. At least 3 years of leadership experience in DMPK.
  • Proven experience in designing, conducting, and interpreting DMPK and/or clinical pharmacology studies supporting small molecule oncology programs.
  • Experience with regulatory submissions is required.
  • Expertise in regulatory requirements and industry standards for DMPK and clinical pharmacology studies (ICH guidelines, FDA regulations etc.).
  • Good exposure and experience in toxicology is a big plus.
  • Excellent communication, collaboration, and leadership skills.
  • Ability to work independently and manage multiple priorities in a fast-paced, team-oriented environment.

ABOUT IAMBIC THERAPEUTICS

Iambic Therapeutics is disrupting the therapeutics landscape with its cutting-edge generative AI drug discovery platform. We have assembled a world-class team that unites pioneering AI experts and seasoned drug hunters with strong track records of success in delivering clinically validated breakthrough treatments. The Iambic Therapeutics platform has been demonstrated to deliver high quality, differentiated drugs to clinic with unprecedented speed and across multiple target classes and mechanisms of action. We are focused on the advancement on our internal pipeline of clinical assets to address urgent unmet patient need in oncology and other therapeutic areas.

MISSION & CORE VALUES

The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.

PAY AND BENEFITS

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life Insurance, 401K matching, and unlimited vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.