Biotech/Pharmaceutical

Associate Director, Pharmacometrician – Remote

Permanent

Penfield Search Partners

Contact: Linda Aronova –  laronova@penfieldsearch.com

Position Overview: Seeking a Pharmacometrician to support or clinical pharmacology development initiatives in oncology.  This position will report to the Head of Global Clinical Pharmacology. This role will partner extensively with our United Kingdom and Swiss-based teams and will need to be based in a location that is conducive to the time difference (preferably located in the Eastern Time Zone).

Primary Responsibilities:

  • In collaboration with multi-disciplinary teams, the incumbent will collaborate closely with the Clinical Pharmacology Lead to support design, analysis and reporting of clinical pharmacology aspects of our development programs
  • Data analysis to characterize the PK profiles, and modeling of exposure-response relationships for safety and efficacy in support of dose justifications, decisions, and future study designs
  • Assess intrinsic and extrinsic covariate effects that may influence the benefit: risk profile
  • Maintain state-of-the-art fluency in emerging modeling and simulation approaches and technologies through awareness of emerging literature and involvement with external training
  • Provide input to global regulatory authority documents, including clinical trial protocols, investigator brochures, regulatory queries, and submission dossiers, and to represent company for our interactions with regulators.
  • Consistent with corporate needs and direction, to routinely present findings both internally and externally, and to support messaging at scientific/medical congresses and in peer-reviewed journals
  • Develop and evolve internal working standards and procedures, as needed

Required Experience and Capability:

  • PharmD, MD or Ph.D degree in pharmacology, or pharmaceutical science, or related fields, with a minimum of 5 years in clinical pharmacology
  • Proficiency with WinNonlin, NONMEM, R, and other pharmacostatistical and modeling software
  • Knowledge of current FDA and ICH regulatory guidelines as related to clinical and clinical pharmacology drug development
  • An appreciation for CDISC standards, as needed, to guide clinical programming colleagues for regulatory submissions (SDTM, ADaM and non-CDISC data submissions)
  • Desire to mentor pharmacology staff in principles related to pharmacostatistical modeling and simulation
  • Willingness to foster a collaborative “can-do” spirit with colleagues in associated cross-functional roles
  • Sound judgement, attention to detail, analytical mindset, and timeliness for work product delivery
  • Excellent verbal and written communication skills

Preferred Requirements

  • Experience with oncology drug development
  • Experience with development of biological and immunotherapeutic agents
  • Familiarity with regulatory submission documents such as INDs, NDAs, MAAs, PIPs and BLAs

Tagged as: Associate Director, Pharmacometrician - Remote