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Director/Senior Director of Clinical Pharmacology

Cambridge, MA

Posted: 05/28/2020 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2547

Job Description

The Director/Senior Director of Clinical Pharmacology will be responsible for developing, driving, and implementing (with internal collaborations and working with consultants/external partners) global Clinical Pharmacology strategies across multiple indications.  You will be a core member of the program teams providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and internal collaborations to help execute programs. The successful candidate will bring extensive experience in clinical pharmacology and work cross-functionally with research and clinical teams to drive programs to success.

  • Develop and execute modeling and simulation plans; use model-based approaches to improve the efficiency of drug development and support dose selection and optimization.
  • Responsible for ensuring/performing appropriate PKPD analysis including population PK, PKPD modeling and simulation, meta-analysis, and disease modeling as required by the program to aid in dose selection, trial design, and/or program decision-making.
  • Design, implement, drive, and monitor Clinical Pharmacology strategies.
  • Work with internal teams and external partners to execute program team objectives.
  • Contribute to program strategy, protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation; write and review clinical pharmacology summary documents.
  • Oversee vendors and consultants as appropriate
  • Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures. Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
  • Accountable and responsible for analysis of PK data Directs the planning of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with translational science and statistics (as relevant).

  • PhD in Pharmacokinetics or Pharmaceutical Sciences, or related field required.
  • A minimum of 10 years’ experience in the biopharma industry in a Clinical Pharmacology role with at least 5 years in Oncology and proven ability to represent Clinical Pharmacology on project teams and with external partners.
  • Experience with NDA or BLA Oncology submissions and regulatory interactions
  • Experience partnering with DMPK and translational science colleagues to ensure relevant clinical pharmacology strategy is developed.
  • Experience working cross-functionally and working with external partners.
  • Strong knowledge of the role of clinical pharmacology in drug development, including the application of translational pharmacology as well as model-based approaches.
  • Ability to perform in fast-paced, dynamic, constantly evolving environment.
  • Excellent communication and organizational skills and attention to detail.
  • Strong time management skills; ability to prioritize multiple tasks efficiently.
  • Participate in implementing model based drug development using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase II results.
  • Fully knowledgeable about the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.
  • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation.
  • Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic.
  • May act as clinician for phase I studies or clinical lead / research project lead for specific drug development projects.

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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