[Remote] Clinical Pharmacology Director

Note: The job is a remote job and is open to candidates in USA. Elemed is a science-led, clinical-stage biotech developing a new generation of biologics for haematologic disease. They are seeking a Senior Clinical Pharmacology Consultant to lead the clinical pharmacology efforts for first-in-human dosing and regulatory submissions, working closely with the development team.

Responsibilities

• Lead dose selection and justification for the first-in-human study
• Build and run the PK/PD, exposure-response and population PK modelling behind the dosing rationale
• Author the clinical pharmacology sections of the IND, protocol and Investigator's Brochure
• Act as the in-house subject matter expert on dosing strategy across development discussions
• Support FDA interactions as required

Skills

• Senior, hands-on clinical pharmacologist (Senior Director level and up, or ED / VP-calibre operating as a consultant) who does the modelling and writing personally rather than directing a team
• Deep clinical pharmacology background in biologics, specifically monoclonal antibodies, with a track record taking programmes from preclinical into first-in-human, including dose setting and ClinPharm submission content
• Toxicology / nonclinical experience
• Oncology or haematology background

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