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Discover International
Boston, MA, United States
About the Company: A growing biopharmaceutical company focused on oncology, partnering with top pharmaceutical companies to develop innovative cancer treatments, is seeking a VP of Clinical Development. They have several succesful partnerships that are set to expand on positive data read outs early 2025. Position Overview: Our client is seeking
Job Source: Discover InternationalSeaport Therapeutics
Boston, MA, United States
The VP, Non-Clinical Development leads the development and execution of the toxicology profiling of Seaport’s drug candidates, including risk assessment /mitigation, development of innovative toxicology strategies, and communication of plans throughout the organization to ensure cross-functional alignment. Seaport Therapeutics is a clinical-stage
Job Source: Seaport TherapeuticsEnsem Therapeutics
Watertown, MA, United States
ABOUT ENSEM THERAPEUTICS: ENSEM Therapeutics (ENSEM) is a Boston-based biopharmaceutical company focused on high value and difficult-to-drug targets in oncology to address unmet medical needs. The name ENSEM symbolizes innovations via the integration of groundbreaking Kinetic Ensem ble technologies for drug design. The Companys mission is to disco
Job Source: Ensem TherapeuticsEnsem Therapeutics
Waltham, MA, United States
ABOUT ENSEM THERAPEUTICS: ENSEM Therapeutics (“ENSEM”) is a Boston-based biopharmaceutical company focused on high value and difficult-to-drug targets in oncology to address unmet medical needs. The name ENSEM symbolizes innovations via the integration of groundbreaking Kinetic Ensem ble technologies for drug design. The Company’s mission is to di
Job Source: Ensem TherapeuticsEnsem Therapeutics
Watertown, MA, United States
ABOUT ENSEM THERAPEUTICS: ENSEM Therapeutics (ENSEM) is a Boston-based biopharmaceutical company focused on high value and difficult-to-drug targets in oncology to address unmet medical needs. The name ENSEM symbolizes innovations via the integration of groundbreaking Kinetic Ensem ble technologies for drug design. The Companys mission is to disco
Job Source: Ensem TherapeuticsRapport Therapeutics
Boston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition
Job Source: Rapport TherapeuticsZenas BioPharma
Waltham, MA, United States
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutic
Job Source: Zenas BioPharmaBioSpace, Inc.
Cambridge, MA, United States
Job Details The Role: Moderna is seeking a physician with internal medicine training with pharmaceutical experience to lead Clinical Development for our expanding Rare Disease programs. mRNA has promise in several areas of Internal Medicine, including Cardiovascular, Pulmonary, Hematology and invasive indications. We seek an agile clinical develo
Job Source: BioSpace, Inc.Boston, MA, United States
The VP, Non–Clinical Development leads the development and execution of the toxicology profiling of Seaport's drug candidates, including risk assessment /mitigation, development of innovative toxicology strategies, and communication of plans throughout the organization to ensure cross–functional alignment.
Seaport Therapeutics is a clinical–stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph TM technology platform. All the therapeutic candidates in its pipeline of first and best–in–class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first–pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit .
Key Responsibilities
Lead toxicology and nonclinical development for Seaport's small molecule portfolio across preclinical and clinical development.
Formulate toxicology, DMPK, and ADME strategies to integrate with Seaport teams to advance programs.
Represent non–clinical development on project teams and interface with internal stakeholders in discovery and development, as well as interface with regulatory agencies.
Oversee the design and conduct of outsourced toxicology, ADME and safety pharmacology studies.
Analyze and interpret nonclinical toxicology and safety data; summarize and communicate findings, as well as provide guidance on follow–up/mitigation strategies.
Spearhead investigative efforts to elucidate mechanism of toxicity as needed.
Manage collaborations with CROs and consultants to support non–GLP and GLP studies.
Review and edit draft study reports and ensure timely finalization.
Author high quality regulatory documents including contributions to IND, CTA, BLA, NDA, IB, as well as contribute to communications with regulatory agencies.
Participate in the preparation of posters, abstracts, and manuscripts for publication.
Perform all duties in keeping with Seaport's values, policies, and all applicable regulations.
Qualifications
PhD in Toxicology, Biology, Pharmacology, or other relevant field with minimum 12 years of professional/industry experience in toxicology–related research and/or drug discovery and development.
Certified Diplomate of the American Board of Toxicology preferred.
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Email Alert for VP, Non Clinical Development jobs in Boston, MA, United States
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