What are the responsibilities and job description for the Clinical Pharmacologist position at Biomea Fusion?
Position Summary:
The Clinical Pharmacologist will be responsible for supporting clinical pharmacology and DMPK activities at Biomea Fusion. This role works with clinical development teams to design and execute clinical pharmacology studies, perform PK data analysis, PBPK and Population PK modeling, and review clinical pharmacology study protocols and reports. This role may involve working in the DMPK lab to generate in vitro ADME data. This role is onsite.
Essential Responsibilities:
- Perform PK NCA and compartmental analysis using WinNonlin, population PK modeling using Monolix, and potentially PBPK and DILIsym modeling.
- Represent Clinical Pharmacology as a member of clinical sub-team, by contributing to clinical trial design and clinical study protocols, coordinating clinical trial conduct and PK sample reconciliation, reviewing clinical study reports.
- Execute program specific Clinical Pharmacology strategy and plan.
- Monitor CROs for DMPK and Clinical Pharmacology related studies and activities, ensuring accuracy of project delivery and proactively identifying hurdles and providing solutions.
- Co-author regulatory documents for submission to global health authorities, including eCTD sections for IND and NDA, Investigators Brochure (IB), and Briefing Documents.
Education and Experience Requirements:
- Advanced Degree in clinical pharmacology, pharmaceutical sciences, or related areas.
- At least 2-3 years of relevant industry experience
- Working knowledge with common tools for quantitative clinical pharmacology (such as WinNonlin and Monolix) and prior experience conducting NCA, noncompartmental analysis, population PK/PD analysis, and PBPK modeling is strongly desired.
- Excellent written and oral communication skills.
- Good at collaborating in a multi-disciplinary team environment.
- Ability to adapt to changing business needs by prioritizing multiple tasks.
Industry:
Biotechnology
Employment Type:
FTE
Equal Employment Opportunity
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Compensation:
The anticipated salary range for fully qualified candidates applying for this role is from $125.000 to $145,000. The actual title and salary offered is based multiple factors including education, relevant industry experience, and length of industry experience; these factors will influence the actual title and salary offered. Our competitive salary is only one part of the overall total rewards program, which includes the opportunity to participate in stock programs, performance-based bonus programs and a competitive benefits package.
Salary : $125,000 - $145,000
