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Director, Pharmacometrics

Position Summary

Achaogen is seeking a Director of Pharmacometrics to lead the pharmacometrics function for early and late-stage development programs in our growing pipeline. The pharmacometrician will work closely with colleagues in Clinical Pharmacology, Microbiology, Clinical Sciences, and Biostatistics. The successful candidate will be responsible for developing and implementing the program-specific pharmacometrics strategies, conduct internal analyses and manage relationships with external pharmacometrics vendors. The ideal candidate will also be able to support the design, execution, and analysis of clinical studies. This is a unique opportunity for a driven individual to establish a Pharmacometrics function at Achaogen and build the capabilities and infrastructure from scratch within a growing Clinical Pharmacology group.

Essential Functions

  • Conduct in-house pharmacometrics analyses and oversee external pharmacometrics activities for early and late-stage development programs, such as population PK models, PK/PD analyses, exposure-response analyses, clinical trial simulations, and other model-based analyses. This may include modeling and simulation (M&S) in support of First-in-Human, as well as special population PK studies.
  • Manage external resources (CROs, consultants, etc.) to meet the pharmacometrics needs of the company.
  • Establish pharmacometrics capabilities and infrastructure in collaboration with the Clinical Pharmacology, Biostatistics, and Information Technology groups.
  • As the pharmacometrics lead on cross-functional drug development teams, develop and execute M&S plans that are fully integrated with overall clinical plans.
  • By using state of the art M&S methodologies, provide pivotal contributions to decisions at critical milestones based on quantitative principles in close collaboration with Biostatistics and Clinical Pharmacology.
  • Identify oversee and manage external vendors and consultants supporting the pharmacometrics function.
  • Clearly identify and communicate potential project hurdles, suggest solutions and establish priorities and contingency plans in collaboration with various stakeholders and project teams.

Preferred Experience and Education

  • PharmD or PhD with a focus in pharmacometrics, PK/PD, PBPK, systems pharmacology, or a related field and 10-12 years (PhD) or 12+ years (BA/MS) of postgraduate experience with a minimum of 3 years in an industry R&D environment.
  • Excellent programming skills in all major pharmacometrics tools including but not limited to NONMEM, Phoenix, SAS, R, etc.
  • Hands-on experience in coordinating pharmacometrics work by CROs, consultants, etc., including collaboration with legal and finance groups to establish contracts and payments
  • Strong publication record in the area of pharmacometrics coupled with a high level of scientific curiosity and analytical thinking skills.
  • Experience in coordinating pharmacometrics components for submission with marketing applications to FDA and other agencies, as well as the writing of IND packages and other regulatory documents.
  • Proven ability to translate high-level scientific concepts and analysis goals into pharmacometric analysis plans and code.
  • Ability to develop and deliver clear and concise presentations for both internal meetings and external conferences
  • Demonstrated outstanding written and verbal communication skills including presentation effectiveness.

Preferred Additional Skills

  • Experience in antibacterial or anti-infective drug development.
  • Hands-on experience with design, conduct and analysis of clinical studies and ability to work broadly on clinical pharmacology tasks.
  • Strong organizational and interpersonal skills.
  • Well-developed critical reasoning skills.
  • Independent, innovative, and creative thinker.
  • Excellent team interaction skills along with demonstrated ability to influence others.
  • Proven ability to positively impact company culture and demonstrate flexibility in fast-paced environment.
  • Committed to the values of integrity, accountability, transparency, scientific rigor, and drive.
  • Ability to travel domestically and internationally.
  • Current US work authorization required.
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