Ensem Therapeutics is seeking a VP and Head of Clinical Development. The successful candidate will be a highly motivated & results-driven
individual with extensive oncology clinical development experience in biotech and/or pharma. S/he 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.
· 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 on 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.
· 5+ 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.