Director - Clinical Pharmacology

About the Department                                                                                                                                             

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

The Pharmacology Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in Clinical Development program(s), Dosage and administration strategy, including dose setting and dosing regimen for project(s), Scientific and pharmacology aspects of trials in the clinical development programme and knowledge-sharing as expert in clinical pharmacology, PK/PD, dosage and administration. This role is highly cross-functional and may involve some travel.

 

Relationships

Reports to the Sr Director, Clinical Pharmacology for the U.S. East Coast Hub. Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory, Data Science (statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs, Global Safety (GS), Bioanalysis, CMC and occasionally with leadership in Medical and Science.

 

Essential Functions

• Clinical pharmacology strategy for phase 1-4 in Clinical Development program(s)
  • Develop clinical pharmacology strategy for project(s) and align with Global Project Team(s) (GPT), Medical & Science Team(s) (MST) (if applicable), and line of business
  • Responsible for clinical pharmacology strategy in the Product Development Plan
  • Responsible for designing the clinical pharmacology trials to match strategy
  • Ensure scientific quality of Clinical Pharmacology Summary and other documents with clinical pharmacology such as Investigator’s Brochure and Health Authorities interactions in line with strategy
  • Attend and negotiate clinical pharmacology aspects at internal and external meetings with e.g. regulatory authorities /advisory board meetings / governance boards / investigator meetings / safety committees according to strategy
• Dosage and administration strategy, including dose setting and dosing regimen for project(s)
  • Develop dosage and administration strategy for project(s) and align with GPT(s) and MST(s) (if applicable) and line of business
  • Maintain overview of
    • PK/PD properties of drug and commercial aspirations for dosage and administration
    • Activities that impact dosage and dose setting including CMC, Device, Non-clin and clinical activities
    • Available and future studies that can support dose setting

• Scientific and pharmacology aspects of trials in the clinical development programme
  • Scientifically responsible for clinical pharmacology protocol outline/protocol(s)
    • Ensure scientific quality, model informed drug development and innovation in clinical pharmacology trials
    • Ensure trial design is aligned with overall clinical pharmacology and dosing strategy
    • Ensure appropriate cost/benefit of planned assessments and align with the needs of relevant stakeholders

• Support scientific aspects of clinical trial application and trial conduct
  • Provide clinical pharmacology input to Health Authority and Ethics Committee
  • Be contact to Investigator on scientific aspects of the trial
  • Facilitate trial safety groups in First human dose (SAD/MAD) studies
  • Take responsibility for assessment, evaluation, and interpretation of scientific data until reporting of trial is complete

• Knowledge-sharing as expert in clinical pharmacology, PK/PD, dosage and administration
  • Development of own competencies in clinical pharmacology, PK/PD and dosing aspects in perspective of the assigned project(s)
  • Preparation and presentation of publications
  • Interpretation of external and competitor data
  • Due diligences
  • Support and maintenance of an external network, e.g. advisory boards, including investigators, key opinion leaders and key research scientists
  • Active contribution of knowledge sharing in pro