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Associate Director, Clinical Pharmacology

Position Summary:   

This position is responsible for designing and executing clinical pharmacology strategies for assets in Achaogen’s portfolio. The successful candidate will be a subject matter expert in clinical pharmacology who has experience providing scientific/technical guidance in decision-making. The Associate Director will represent clinical pharmacology on cross-functional teams and will serve as a liaison for information on PK, drug metabolism, toxicokinetics, and bioanalysis within the development organization and to regulatory authorities. The individual will work closely with the Microbiology function to develop PK/PD targets and target attainment analyses, will coordinate work at CROs, and will write/review study reports and relevant sections of regulatory submissions. The individual will maintain knowledge of current regulatory guidelines and company SOPs and policies and ensure compliance in performing job duties, including those performed by subordinates. Strong interpersonal and outstanding written and verbal communication skills are essential.  

Essential  Functions:

  • Major contributor to the scientific/technical aspects of assigned clinical pharmacology studies from conception through final report, including first-in-human, drug-drug interactions, specialty PK, ADME, and pediatric population studies
  • Represent clinical pharmacology on cross-functional teams; identify and communicate potential project hurdles, suggest solutions, and leverage the clinical pharmacology leadership to establish priorities and contingency plans
  • Contribute to regulatory submissions, including INDs, IBs, NDAs, MAAs and pediatric plans
  • Collaborate with clinicians, microbiologists, biostatisticians, regulatory affairs, and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes
  • Articulate clinical pharmacology plans and study results to development teams and/or senior management
  • Identify and manage external vendors and consultants supporting the clinical pharmacology function
  • Conduct and supervise NCA PK analyses using WinNonlin software
  • Liaise with KOLs and academic collaborators on clinical pharmacology science and methodology and author/review abstracts/manuscripts generating high-quality presentations/publications
  • Identify rate-limiting issues, anticipate problems, and effectively communicate with the appropriate parties, offering proactive resolutions

Preferred Experience and Education:

  • PhD (or PharmD with relevant post-doctoral training) in clinical pharmacology, pharmacometrics, or related field
  • 5+ years of relevant industry experience in clinical pharmacology, pharmacometrics, or related discipline(s).
  • Experience in antibacterial or anti-infective drug development
  • Proficient at conducting population PK, PK/PD, PBPK analyses using vendor-based software (Simcyp, GastroPlus, NONMEM, SPLUS, R, etc.)
  • Proven track-record in drug development, clinical pharmacology and pharmacokinetics, and clinical research concepts and practices
  • Strong publication record in the area of nonclinical and clinical ADME/PK coupled with a high level of scientific curiosity and analytical thinking skills

Preferred Additional Skills:

  • Previous experience with therapeutic drug management (TDM)
  • Previous active participation in an FDA Anti-Infective Drugs Advisory Committee Meeting
  • Strong organizational and interpersonal skills.
  • Well-developed critical reasoning skills and in risk management assessments.
  • Independent, innovative, and creative thinker.
  • Proven ability to positively affect company culture and demonstrate flexibility in fast paced environment.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally.
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