Current jobs related to Director, DMPK - Cambridge - FogPharma
-
Associate Director
2 months ago
Cambridge, United States Delphia Therapeutics Full timeAbout Us:Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first-in-class targeted cancer medicines that can provide better and more durable outcomes for...
-
Associate Director
2 months ago
Cambridge, United States Delphia Therapeutics Full timeAbout Us:Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first-in-class targeted cancer medicines that can provide better and more durable outcomes for...
-
Associate Director
3 weeks ago
cambridge, United States Delphia Therapeutics Full timeAbout Us:Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first-in-class targeted cancer medicines that can provide better and more durable outcomes for...
-
Associate Director
3 weeks ago
cambridge, United States Delphia Therapeutics Full timeAbout Us:Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first-in-class targeted cancer medicines that can provide better and more durable outcomes for...
-
Senior Director, DMPK
4 months ago
Cambridge, United States Bicycle Therapeutics Full timeJob DescriptionJob DescriptionCompany DescriptionBicycle 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...
-
Associate Director, DMPK
1 week ago
cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage pharmaceutical 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 geometry. This...
-
Associate Director, DMPK
3 days ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage pharmaceutical 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 geometry. This...
-
Associate Director, DMPK
1 week ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage pharmaceutical 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 geometry. This...
-
Associate Director, DMPK
1 week ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage pharmaceutical 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 geometry. This...
-
Associate Director, DMPK
2 days ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage pharmaceutical 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 geometry. This...
-
Scientific Director, DMPK
4 weeks ago
Cambridge, United States Moderna, Inc. Full timeThe RoleAt Moderna, our mission is to deliver the greatest possible impact to people through mRNA medicines. We foster a dynamic, diverse, and innovative workplace where every individuals contribution is vital.In this role, you will serve as a Drug Metabolism and Pharmacokinetic (DMPK) subject matter expert and functional line representative on drug...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Associate Director of Drug Metabolism and PharmacokineticsBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking an experienced Associate Director of Drug Metabolism and Pharmacokinetics (DMPK) to join our team.Key Responsibilities:Design and execute non-clinical...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob DescriptionThe Associate Director of Drug Metabolism and Pharmacokinetics (DMPK) plays a pivotal role in the success of our drug development pipeline at Bicycle Therapeutics. Reporting to the Vice President of Quantitative Pharmacology, this individual will be responsible for representing DMPK, designing and executing non-clinical studies in support of...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Summary:The Senior Director of Drug Metabolism and Pharmacokinetics (DMPK) will lead a team of scientists in supporting multiple projects from target identification through to candidate selection and regulatory submission.Key Responsibilities:Provide scientific leadership across all stages of the portfolio, collaborating with drug discovery teams,...
-
Cambridge, Massachusetts, United States Recludix Pharma Full timeJob Summary:We are seeking an experienced leader to build our capabilities in support of our small molecule portfolio in inflammation and oncology through IND and development. The candidate will have strategic and scientific oversight of our small molecule discovery and development portfolio and will manage the in vitro and in vivo PK, ADME and bioanalytical...
-
Director, Pharmacometrics
4 months ago
Cambridge, United States Bicycle Therapeutics Full timeJob DescriptionJob DescriptionCompany DescriptionBicycle 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...
-
Lead Scientist, Molecular Bioanalytics
3 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeJob OverviewAt Editas Medicine, our mission is to deliver groundbreaking therapies to individuals facing serious health challenges. We are committed to scientific excellence, leveraging the transformative capabilities of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing technologies.We prioritize our workforce, fostering an environment where every team...
-
Senior Scientist, Molecular Bioanalytics
4 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Lead Scientist, Molecular Bioanalytics
3 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAbout Editas Medicine:At Editas, we are united by a shared mission to deliver transformative therapies to individuals facing serious health challenges. This commitment drives our pursuit of scientific excellence, enabling us to leverage the potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing technologies. We recognize that our employees are the...
-
Director, Preclinical Drug Safety
4 weeks ago
Cambridge, United States Blueprint Medicines Full timeHow will your role help us transform hope into reality? Reporting to the Vice President of Preclinical Drug Safety, you will be responsible for developing and implementing toxicology strategies for multi-disciplinary program teams. You will play a critical role helping derisk and advance the research pipeline by leveraging your toxicology expertise,...
Director, DMPK
4 months ago
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 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
* 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.
