Director / Senior Director, Drug Metabolism and Pharmacokinetics

An exciting opportunity is available for a talented Senior Director to join the Institute of Medicine (IOM) Development Sciences team at Altos Labs.
We are seeking very highly motivated, creative, and collaborative individuals who are passionate and dedicated to employing their expertise to restore cell health and resilience and reverse disease. This position will be part of a multidisciplinary team within the IOM to develop novel therapeutic projects and pipelines at Altos. The candidate will work in a highly dynamic and cross-functional environment that requires collaboration with the Institutes of Science and may span multiple therapeutic areas and therapeutic modalities. The successful candidate will have strong scientific training, be adept with working with traditional and non-traditional therapeutic modalities, and a demonstrated track record of leading DMPK groups in the biotechnology or pharmaceutical industry.

Responsibilities

• Develop and implement DMPK strategies and build infrastructure to support discovery and development programs using internal resources and CROs/consultants
• Recruit scientists and build a team to support DMPK strategy to ensure delivery of high quality data packages in support of target validation through to regulatory filings
• Identify, qualify, and engage external providers of in vitro ADME and in vivo PK services; analyze and interpret resulting data
• Represent DMPK in multifunctional discovery and early development project teams
• Effective cross-functional collaboration, especially with vitro/in vivo pharmacology and toxicology, in the optimization of drug leads and candidates, understanding of PK/PD and human dose projections.
• Contribute to the cross-functional review of regulatory documents and author and review DMPK sections for relevant regulatory documents e.g. IND, IB, MAA and serve as a subject matter expert in composing responses to regulatory queries.
• Recommend, initiate, lead and champion new innovations from external, global and local sources to ensure cutting-edge science is applied to project related issues
• Manage resource allocation, including leveraging CRO partners and internal resources in other Altos Labs groups as needed
• Continuously assess assay capability and capacity needs based on the evolving pipeline at Altos
• Create and foster strong partnerships with groups at the Institutes of Science
• Contributes to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion

Qualifications

• In Pharmaceutical Sciences or related area with a minimum of 10+ years of industry experience in discovery and development DME/PK
• Demonstrated ability to build, manage and lead groups responsible for supporting DMPK deliverables in a team setting
• Strong command of Drug Metabolism, ADME, pharmacokinetics, pharmacodynamic and bioanalytical approaches
• Strong knowledge and agility in study design and data interpretation and in the integration of ADME/PK studies in the drug progression paradigm
• Experience working with CROs to provide ADME/PK support for programs.
• Familiarity with regulatory guidance related to ADME/PK characterization and drug-drug interactions.
• A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-off
• Clear and influential communicator: exceptional influencing skills that demonstrate strong thought partnership and create effective relationships with internal and external groups and individuals

Preferred Qualifications

• Experience working across diverse therapeutic modalities, including small molecules, biotherapeutics, nucleic acid therapeutics, and gene therapy
• Project team leadership experience in the discovery space

The salary for the Director level is $270,300-365,700; Senior Director level salary range is: $308,550 - $417450

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