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Prime Medicine
Cambridge, MA, United States
The Senior Director of Pharmacology and DMPK reporting to the Head of Nonclinical Development will provide scientific, strategic, and hands-on leadership and execution of our R&D-wide strategy for Research. She/he will lead consulting and externally partnered resources, in Discovery and In Vivo Pharmacology, ADME, DMPK, PK/PD Modeling, Colony & CRO
Job Source: Prime MedicineOdyssey Therapeutics
Boston, MA, United States
About Us Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory diseases and cancer. We achieve unprecedented speed and efficiency by bringing together a target-centric approach, a toolbox of cutting-edge technologies, and a team of accomplished
Job Source: Odyssey TherapeuticsAbbVie
Cambridge, MA, United States
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and serv
Job Source: AbbVieBicycle Therapeutics
Cambridge, MA, United States
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geo
Job Source: Bicycle TherapeuticsBicycle Therapeutics Limited
Cambridge, MA, United States
Company Description Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications w
Job Source: Bicycle Therapeutics LimitedDyne 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 IncBioNTech IMFS
Cambridge, MA, United States
Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Associate Director Clinical Pharmacology Open for hire at one of the following locations – Cambridge Erie Street. - Job ID: 7319 Join our team of pioneers! As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions fo
Job Source: BioNTech IMFSTango 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 TherapeuticsCambridge, MA, United States
Why Join Us?
FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ 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 ?-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
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.
What you'll need to be successful: 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.
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.
Email Alert for Director, DMPK / Clinical Pharmacology jobs in Cambridge, MA, United States
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