- You will be an expert in clinical pharmacology/pharmacometrics and the application of quantitative methods to elucidate exposure-response relationships
- Represent the clinical pharmacology department as subject matter expert on development teams and at governance board meetings
- Collaborate with the clinical development teams and/or clinical study teams to optimize patient trial design and execution, explore exposure-response relationships for safety and efficacy, and deliver NDA enabling clinical pharmacology 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 7-10 years' experience in the pharmaceutical and/or biotech industry
- Experience with small molecule drug development in oncology preferred (required for consideration at the Senior Director level)
- In-depth knowledge of drug metabolism, pharmacokinetics, biopharmaceutics, drug-drug interactions, and translational science
- Experience with health authority interactions and regulatory filings
- Experience as lead or contributing clinical pharmacologist on a successful NDA submission preferred (required for consideration at the Senior Director level)
- Familiar with GLP, GCP, and ICH requirements
- Hands-on experience in population pharmacokinetics/pharmacodynamics, and other modeling and simulation approaches preferred (required for consideration at the Senior Director level)
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Director/Senior Director, Clinical Pharmacology - Boston, United States - Third Rock Ventures
Description
As our clinical development portfolio evolves, Tango has an exciting new opportunity to join our team as a Director/Senior Director, Clinical Pharmacology.
Reporting to our SVP, Pharmaceutical Sciences, you will be responsible for the design and implementation of clinical pharmacology aspects of patient trials and NDA-enabling clinical pharmacology studies.
You will be responsible for programs from IND submission through commercialization.You will collaborate with your colleagues in DMPK, preclinical safety, clinical development, clinical operations, and biostats to deliver successful NDA submissions.
Your Role:
What You Bring:
We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
