Green Key Resources
Associate Director, Clinical Pharmacology
Green Key Resources, Boston, Massachusetts, us, 02298
A rapidly growing clinical portfolio focused on innovative therapeutics for CNS indications is hiring for an Associate Director in Clinical Pharmacology. The ideal candidate brings deep expertise in clinical pharmacology, including PK and PD. Success in this position requires strong scientific judgment, excellent communication skills, and the ability to operate independently within a fast paced environment.
Essential Duties and Responsibilities:
Serve as the primary clinical pharmacology lead, offering independent scientific leadership and support to programs progressing through clinical development.
Oversee the evaluation and synthesis of clinical pharmacology results, ensuring clear interpretation and communication of emerging data.
Perform PK and PK/PD assessments that inform dose selection, study design, and broader development strategy.
Contribute specialized clinical pharmacology expertise to regulatory deliverables, including briefing packages and global filings.
Develop and author key clinical pharmacology components of protocols, Investigator Brochures, and Clinical Study Reports with minimal oversight.
Work in close coordination with bioanalytical, clinical development, regulatory, project management, and other cross‑functional partners to advance program objectives
Qualifications and Preferred Skills:
Doctoral degree (Ph.D. or Pharm.D.) in a relevant discipline such as in quantitative or clinical pharmacology, along with substantial experience in the biotech or pharmaceutical sector.
Strong expertise in clinical pharmacology, including PK, PK/PD, modeling and simulation, ADME concepts, and interpretation of clinical data.
Experienced with key pharmacokinetic and modeling platforms, including Phoenix WinNonlin, R, NONMEM, and comparable data visualization software.
Able to take initiative and drive work forward independently.
Highly effective communicator with strong writing and presentation abilities.
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Essential Duties and Responsibilities:
Serve as the primary clinical pharmacology lead, offering independent scientific leadership and support to programs progressing through clinical development.
Oversee the evaluation and synthesis of clinical pharmacology results, ensuring clear interpretation and communication of emerging data.
Perform PK and PK/PD assessments that inform dose selection, study design, and broader development strategy.
Contribute specialized clinical pharmacology expertise to regulatory deliverables, including briefing packages and global filings.
Develop and author key clinical pharmacology components of protocols, Investigator Brochures, and Clinical Study Reports with minimal oversight.
Work in close coordination with bioanalytical, clinical development, regulatory, project management, and other cross‑functional partners to advance program objectives
Qualifications and Preferred Skills:
Doctoral degree (Ph.D. or Pharm.D.) in a relevant discipline such as in quantitative or clinical pharmacology, along with substantial experience in the biotech or pharmaceutical sector.
Strong expertise in clinical pharmacology, including PK, PK/PD, modeling and simulation, ADME concepts, and interpretation of clinical data.
Experienced with key pharmacokinetic and modeling platforms, including Phoenix WinNonlin, R, NONMEM, and comparable data visualization software.
Able to take initiative and drive work forward independently.
Highly effective communicator with strong writing and presentation abilities.
#J-18808-Ljbffr