- Be an expert in clinical pharmacology with demonstrated experience in using and advocating the use of quantitative analyses to support drug development.
- Collaborate with clinical study teams to optimize patient trial design, execute clinical studies and contribute to relevant sections of clinical study protocols.
- Explore exposure-response relationships for safety and efficacy using preclinical, translational and clinical data to support dose/dosing regimen selection for clinical evaluation.
- Ensure high-quality and timely delivery of relevant sections of regulatory documents for global health authority submissions.
- Represent clinical pharmacology as subject matter expert on cross-functional project teams and global health authority interactions.
- Provide oversight for DMPK/clinical pharmacology related sample management activities including management of BA CROs.
- Contribute to the design and oversight of toxicokinetic aspects for GLP toxicology studies.
- Establish and maintain productive relationships with key internal business partners, consultants, and CROs.
- Additional duties and responsibilities as required.
- PhD or PharmD in clinical pharmacology, pharmacometrics, or related discipline with at least 7 years of experience in the pharmaceutical and/or biotech industry
- Hands-on experience in population pharmacokinetics/pharmacodynamics, and other modeling and simulation approaches to investigate PK/PD relationships for peptides therapeutics.
- In-depth knowledge of bioanalytical methods to assess PK and disposition of peptide therapeutics in biological matrices.
- Excellent critical thinking and scientific skills with a demonstrated ability to analyze, interpret, and clearly communicate complex results.
- Ability to work effectively and collaboratively on cross-functional project teams.
- Experience with parenteral drug development in oncology preferred.
- Experience with health authority interactions and regulatory filings preferred.
- Experience as a contributing clinical pharmacologist on a successful NDA/BLA submission preferred.
- Familiar with GLP, GCP, and ICH requirements.
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Director, DMPK - Cambridge, United States - FogPharma
Description
Job Description
Job DescriptionWhy Join Us?
FogPharma is a biopharmaceutical company pioneering the discovery and development of HeliconTM therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.
FOG-001, the company's first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. FogPharma is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass.
What's the opportunity?
FogPharma has an exciting new opportunity for a Director, DMPK/Clinical Pharmacology reporting to our AVP, Clinical Pharmacology/Development DMPK. In this role, you will be responsible for the design and implementation of clinical pharmacology aspects of patient trials. You will be responsible for programs from IND submission through clinical proof-of-concept. You will collaborate with your colleagues in Discovery DMPK, biology, preclinical safety, clinical development, clinical operations, translational medicine and biostatistics to deliver high-quality deliverables following selection of a development candidate through clinical proof-of-concept.
Responsibilities
What you'll need to be successful:
As an equal opportunity employer, Fog values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
