Location: Cambridge MA
We are seeking a highly motivated and enthusiastic physician with hands on expertise to 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 oncology/hematology clinical trials. 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 Responsibilities
- Leads and demonstrates ownership of the design and implementation of a clinical development program based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, business operations, and emerging issues.
- 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.
- Oversees project-related education of investigators, study site personnel, and H3B’s study staff.
- 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.
- Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, accrual, and safety data review.
- Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- MD (MD/PhD preferred) with board qualification or experience in medical oncology.
- A minimum of three (3) years related clinical oncology experience in a pharmaceutical company, biotech firm is required.
- Technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies.
- Successful clinical research publication history.
- 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.
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.