Associate Director / Director / Snr Director, DMPK and Clinical Pharmacology - Modelling and Simulation

Reference: SWR532

Expiry Date: 31-01-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
United States

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Job Description

My client is a small but well-funded and expanding biotechnology company (HQ in MA) focused on delivering transformational therapies for patients with serious, genetically defined diseases. They are led by an impressive senior executive leadership team.

This client is currently hiring for an Associate Director, Director or Snr Director, DMPK and Clinical Pharmacology - Modelling and Simulation to lead the design, planning and execution of DMPK and clinical pharmacology studies.

This individual will be responsible for all aspects of DMPK and clinical pharmacology strategies spanning from early development (pre-IND) through late stage-development (Phase 3, filings worldwide, and lifecycle management). The individual will be a recognized subject matter expert in the field of DMPK and clinical pharmacology who can interpret PK/PD data and integrate PK, PD, safety, and efficacy data to ensure that appropriate dose and schedule decisions are made using model and simulation strategies. The candidate will represent the department at cross-functional team meetings, working in close collaboration with colleagues responsible for Regulatory, Toxicology, Bioanalytical, Biomarker, Data Sciences, and Clinical Operations. Key responsibilities will include planning, writing and reviewing study designs and data analysis plans, preparation of documentation relating to clinical pharmacology (e.g. clinical pharmacology protocols, study reports, regulatory documents such as IBs, INDs, briefing packages for regulatory meetings and major sections of regulatory filings), and negotiation with Health Authorities worldwide regarding clinical pharmacology issues.

POSITION RESPONSIBILITIES:

  • DMPK and Clinical Pharmacology representative on clinical and study teams and works in close collaboration with multidisciplinary team to progress drug candidates from R2D transition through preclinical and clinical development to successful approval.
  • Responsible for the design, planning, oversight as well as the analysis, interpretation and reporting of results of DMPK studies.
  • Responsible for the design, planning, oversight as well as the analysis, interpretation and reporting of results of Clinical Pharmacology studies.
  • Interfaces with discovery research colleagues during pre-clinical stages of development to plan and ensure sufficient PK/PD knowledge exists for translation to clinic.
  • Applies scientific knowledge and experience to cover a breadth of areas including the design, execution, and interpretation of ADME, CYP inhibition/induction, transporter, PK/PD and clinical pharmacology studies.
  • Applies quantitative skills to support model-based drug development and address complex issues via modeling and simulation.
  • Responsible for DMPK and clinical pharmacology contributions to regulatory documents and responses.
  • Understands and effectively applies appropriate regulatory guidelines to drug development.

EDUCATION/EXPERIENCE:

  • PhD, Pharm D or equivalent in clinical pharmacology, pharmacokinetics, pharmacometrics or a related field with more than 5 years of relevant industry experience
  • An outstanding track record of aptitude/problem solving in the field of DMPK and clinical pharmacology
  • Demonstrates a sound knowledge of DMPK, clinical pharmacology and PK/PD principles, 
  • Experience with PK/PD modeling and simulation is a must
  • Proficient in PK modeling software/platforms including, but not limited to, NONMEM, R and population PK/PD modeling.
  • Adept at presentation of clear and accurate reports for internal and external projects
  • Prior experience in industry exploring or utilizing oligonucleotide synthesis is preferred 
  • Ability to innovate and think creatively to support development activities and drug development process
  • Experience working within a start-up or small biotech business environment is preferred
  • Capacity to work flexibly and efficiently in a dynamic, fast-paced work environment
  • Collaborative and self-motivated team player
  • Effective communication and interpersonal skills
  • Strong presentation skills

 

To Apply!

If you have the experience and are interested in joining a smaller but growing and very experienced team, please contact me, Roland Schnapka on  Roland@advtalent.com or US Direct:  908 348 6717 for a confidential discussion.

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