Location: Cambridge MA
We are seeking a highly motivated and enthusiastic physician with hands on expertise in taking novel oncology compounds from first in human through to completion of phase 2 clinical trials. This will support H3’s continued effort to identify unique anti-cancer compounds for the treatment of targeted patient populations. The main focus managing all aspects related to the planning and execution of global clinical trials and will be responsible for the conduct of multiple clinical trials in hematologic malignancies and will report to the CMO. The successful candidate will function as a scientific and medical resource for the Clinical Development department at H3 Biomedicine as well as a liaison to development partners. Preparation of study related materials, relationship management between study sites, leveraging internal and external (CRO) development resources and the supervision of all other study related activities. The individual in this role will also be responsible for the identification of project risks, contingency planning implementation and operating within the project timelines and budget.
Principal Duties and ResponsibilitiesLeads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, H3B’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and H3B’s study staff. Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Participate in the development of clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the head of clinical operations. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- Collaborate with clinical and discovery scientists, regulatory professionals, biostatisticians, clinical operations and other colleagues in the development and execution of a clinical program
- Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review.
- Conduct safety monitoring in collaboration with pharmacovigilance groups of active clinical studies.
- Lead the analysis, interpretation and reporting of clinical study data
- Working with other H3 clinical and regulatory colleagues, address health authority and ethics committee queries.
- Represent H3 at medical meetings, advisory boards and other KOL/investigator outreach meetings as needed.
- Collaborate in the preparation of publications (abstracts, posters, manuscripts) of data from H3 clinical programs
QualificationsMD, MD/PhD in life sciences or healthcare required. Clinical oncology experience; Board certification in oncology or hematology preferred, Soilid tumor experience a plus. A minimum of three (3) years related clinical oncology experience in a pharmaceutical company, biotech firm, or CRO is required. This includes technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies. Proven ability to work independently and to lead a multidisciplinary trial team in a complex matrix environment. Experience in developing effective relationships with key investigators. Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process. Advanced knowledge of Oncology and Hematology is necessary.
- MD (MD/PhD preferred) with board qualification or experience in medical oncology
- At least 3 years of clinical development experience within the pharmaceutical or biotechnology industry.
- Working knowledge of the clinical drug development process.
- Track record in the conduct/participation in company sponsored clinical trials
- Successful clinical research publication history
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.