Location: Cambridge MA
Job Code: CLSCI-022020
Cambridge, MA-based H3 Biomedicine (http://www.h3biomedicine.com/) is a leading company in cancer genomics driven drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented $200 million in initial funding from Eisai, plus a continued ongoing commitment to fund H3’s robust discovery pipeline and clinical programs. Now with three clinical stage anti-cancer molecules in active development, H3 is able to uniquely leverage distinct insights from cancer genomics and real-life patient data to advance its projects to clinical proof of concept and beyond. H3 embraces a novel business model in which it collaborates with Eisai, a leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform.
Principal Duties and Responsibilities
- Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
- In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plan to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization
- Collaborate within Development on the review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
- Identify study issues and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team to ensure issue resolution. Conduct literature reviews as needed for the interpretation of study data and development of next steps.
- Works closely with the medical monitor to assure he/she is informed of pertinent study information, including but not limited to safety and efficacy data.
- Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
- Translational medicine: Support the implementation of target/pathway engagement assays for selecting therapeutically relevant doses and schedules; support stratification biomarkers.
- In conjunction with the Team Leader/Clinical Leader/CMO, develop presentations and communicates study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Serve as clinical science representative on cross-function teams as assigned
- Candidates must have an advanced clinical or science degree e.g. Pharm.D., PhD in a clinical discipline, M.D.
- 5+ years of clinical research experience in planning, executing, reporting and publishing studies within the pharmaceutical industry. Demonstrated ability to review and summarize study data, including experience in preparing and presenting data. Late stage development/registrational experience is preferred.
- Thorough understanding of the drug development process from pre-IND through registration and post-registration required
- Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
- Fluency in the English language, both written and verbal.
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
- Successful track record for the ability to interpret, analyze, and present clinical data, including aggregate data analyses, in order to inform decision-making and set clinical strategy.
- Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
- Hands-on experience performing systematic literature search, summarizing the search results and presenting the conclusions to wide spectrum of audience.
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
- Strong organization, documentation and communication skills with an ability to multitask.
- Excellent interpersonal skills; ability to collaborate across disciplines.
- Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
- Ability to travel up to approximately 30% of time.
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.