- 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.
- 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.
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VP and Head of Clinical Development - Waltham, United States - ENSEM Therapeutics
Description
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 Company's 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 ENSEM's 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 company's 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:
Qualifications:
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.
