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Relay Therapeutics
Cambridge, MA, United States
The Opportunity: The Director/Senior Director of Clinical Pharmacology serves as Clinical Pharmacology Lead on core drug development teams. The successful candidate will embrace model-based drug development and lead clinical pharmacology strategy, planning, and delivery for assigned programs and clinical studies. You will play a key role in influe
Job Source: Relay TherapeuticsTango Therapeutics
Boston, MA, United States
Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that t
Job Source: Tango TherapeuticsDyne Therapeutics Inc
Waltham, MA, United States
Role Summary: The Senior Director of Clinical Pharmacology will provide leadership to the Clinical Pharmacology and Pharmacometrics team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all programs at Dyne Therapeutics. This person will be the companys subject matter expert (SME)and will be r
Job Source: Dyne Therapeutics IncDyne Therapeutics Inc
Waltham, MA, United States
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscl
Job Source: Dyne Therapeutics IncDyne Therapeutics Inc
Watertown, MA, United States
Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscl
Job Source: Dyne Therapeutics IncDyne Tx
Waltham, MA, United States
Our commitment to people with muscle diseases is our greatest strength We support all people, families and caregivers living with rare diseases, this Rare Disease Day and every day Senior Director, Clinical Pharmacology Apply for this job Department: 125 Translational Biomarkers Location: Waltham, MA Company Overview: Dyne Therapeutics is a cl
Job Source: Dyne TxNovo Nordisk
Lexington, MA, United States
About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnersh
Job Source: Novo NordiskFairway Consulting Group
Boston, MA, United States
Our client is a biotechnology company focused on oncology. They have asked us to assist them in their search for a Senior Director, Clinical Pharmacology. Major tasks and responsibilities include: Formulates and executes the clinical pharmacology strategy for the company's drug development programs, taking into consideration the unique characteri
Job Source: Fairway Consulting GroupBoston, MA, United States
Company Overview
Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.
Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.
This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts
Summary
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:
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
What You Bring:
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)
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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Email Alert for Director/Senior Director, Clinical Pharmacology jobs in Boston, MA, United States
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