[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 reputed company of biologics for haematologic disease. They are seeking a Senior Clinical Pharmacology Consultant to reputed company the clinical pharmacology efforts for first-in-human dosing and regulatory submissions, working closely with the development team.
Responsibilities
- reputed company 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
Company Overview