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Ensem 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 TherapeuticsSeaport 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 TherapeuticsDiscover 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 b
Job Source: Seaport TherapeuticsConfidential
Boston, MA, United States
Head of Clinical Development About the Company Pioneering CAR-T biotechnology (BioTech) platform Industry Biotechnology Type Privately Held About the Role The Company is seeking a Head of Clinical Development to lead the strategic and operational aspects of clinical programs, with a focus on lymphoma. The successful candidate will be responsible
Job Source: ConfidentialJobFlurry-Appcast-US
Boston, MA, United States
Hobson Prior is seeking a dynamic and accomplished professional for the role of Head of Clinical Development. This role involves leading and managing the clinical development team, providing strategic guidance, and overseeing clinical trial data. The ideal candidate will have a strong background in Oncology drug development and clinical research.Pl
Job Source: JobFlurry-Appcast-USHobson Prior
Boston, MA, United States
Hobson Prior is seeking a dynamic and accomplished professional for the role of Head of Clinical Development. This role involves leading and managing the clinical development team, providing strategic guidance, and overseeing clinical trial data. The ideal candidate will have a strong background in Oncology drug development and clinical research. P
Job Source: Hobson PriorHobson Prior
Boston, MA, United States
Hobson Prior is seeking a dynamic and accomplished professional for the role of Head of Clinical Development. This role involves leading and managing the clinical development team, providing strategic guidance, and overseeing clinical trial data. The ideal candidate will have a strong background in Oncology drug development and clinical research. P
Job Source: Hobson PriorWatertown, 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 discover, develop, and commercialize transformative oncology therapies for patients, while leading the advancement of AI-driven structural ensemble and computational drug design. To this end, ENSEM has recently entered into an agreement with BeiGene which acquired an exclusive global license to ENSEMs Investigational New Drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor and ENSEM anticipates multiple additional best-in-class or first-in-class agents from its growing pipeline to enter I the clinic in 2025 and 2026. These new programs will provide a rich opportunity for a motivated individual to lead the companys business development effort.
Position:
The successful candidate will be a highly motivated and results-driven individual with extensive Oncology clinical development experience in biotech and/or pharma. They will work closely with preclinical Research team as well as external clinical consultants, drive the strategic planning and execution of first-in-human clinical trials through registrational studies.
Responsibilities:
Review preclinical data and design first-in-human clinical trials for best- and/or first-in-class Oncology small molecules.
Along with the project team, external consultants, and academic thought-leaders, the candidate will design clinical strategies to define proof-of-concept, as well as registration, and will execute these strategies.
Drive clinical study design, lead study protocol development, and collaborate with cross-functional teams and clinical investigators in all study activities.
Oversee management of clinical trials, including investigator/site selection, patient recruitment strategies, milestones, and develop effective working relationships with clinical investigators, thought leaders, clinical consultants and CROs.
Accountable for the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, and other periodic clinical reports.
Direct, hands-on involvement in all aspects of clinical study conduct, including data review, analysis, and reporting that conforms to the highest ethical, safety, and quality standards and in compliance with regulatory standards,
Manage internal and external resources to ensure clinical research plans are executed on time and within budget.
Engage external business partner(s) and exert influence on joint clinical development strategy and study designs, with the goal of advancing ENSEM molecule from early clinical trials to final approval.
Remain current on the therapeutic landscape in the relevant therapeutic areas in order to provide input and guidance for the strategic direction,
Promote open, collaborative and entrepreneur culture.
Qualifications:
MD or MD PhD with board certification in the field of Medical Oncology.
8+ years of experience in the design, execution, and reporting of clinical trials in oncology preferably with small molecule drugs in pharmaceutical/biotech industry (or a combination of academia and industry).
Excellent scientific knowledge relevant to clinical oncology, especially in the development of targeted therapies.
In-depth knowledge of medical aspects of GCP, ICH, FDA, EMA, and other Country-specific guidelines and regulations for global submissions.
Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents.
Excellent leadership skills and proven ability to effectively work in a cross-functional/matrix environment and with contractors and CROs.
Strong interpersonal, influencing, presentation, and written communication skills.
Excellent organizational and time management skills.
Dynamic, self-motivated, innovative, and critical thinker.
Ability to travel to clinical trial sites, Conferences, Advisory Board meetings, etc.
ENSEM Therapeutics, Inc. is an Equal Opportunity employer and does not discriminate against an applicant or employee because of race, creed, color, religion, sex, national origin, ancestry, age, sexual orientation, physical or mental disability, or veteran status.
The duties listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
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Email Alert for VP and Head of Clinical Development jobs in Watertown, MA, United States
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