This role reports through the Clinical function which provides scientific expertise necessary to design, implement and interpret data from clinical studies. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies in collaboration with Clinical Operations and Chief Medical Officer. This role will be responsible for the scientific aspects global clinical trial delivery including protocol design and writing, analysis of data, management and reporting of trials in accordance with company plans/objectives, ICH-GCP, country requirements and company standard operating procedures. Specifically, this includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, supporting site selection, data review and writing/reviewing the clinical study report, for one or more clinical trials. Other important tasks will be supporting the Chief Medical Officer and Chief Operating Officer planning, publication strategy and other tasks.

Ideal candidate would be based locally to Norwood, Ma hybrid. Would consider remote candidates with some travel to Norwood, Ma.

Key Responsibilities:

• Provide data analysis and study support for ongoing oncology programs
• Work with CMO and Clinical Development team to design or amend study protocols
• Review data from clinical trials and provide summaries to management
• Support publications as needed – expected ASCO and ESMO conferences.      
• Draft clinical documents as needed. For example, support Pivotal Protocol draft and finalization. 
• Review clean SMART Patient Profiles that are ready for data freeze. 
• Support regulatory team with data and review of any relevant regulatory document. Ex: briefing book, breakthrough designation.
• Work with biostats to support any new data analysis or requests for outputs
• Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, statistical analysis plans, study plans, CSRs.
• Evaluate innovative trial designs in collaboration with Chief Operating Officer and Chief Medical Officer
• In collaboration with internal/external experts on biostatistics, clinical pharmacology, translational medicine, clinical operations and data management, contributes to the development of the plans to execute on trial design including CRF design, data review plan, statistical analysis plan review and finalization.
• Co-lead the cross-functional clinical trial working groups, collaborating with Clinical Operations and extern functions to drive delivery and facilitate issue resolution.
• Collaborate with Clinical Operations to plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally.
• Collaborate with other Corbus functions to support effective study specific vendor interactions
• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
• Drive the review, analysis, and interpretation of study results ensuring that accurate conclusions are drawn and working with our CMO to appropriately contextualize
• Identify study and program-wide 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 CMO to ensure they are 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 (DSURs) and periodic updates, and clinical sections of regulatory submissions to support product approvals.
• In conjunction with the CMO, develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences.

•  Minimum of a BA/BS in Life Sciences Degree with 7+ years of experience or an advanced clinical/science degree e.g. MA + 5 years of clinical or PharmD/PhD +3 years.
• Significant experience working in early and late phase oncology is required to ensure proficiency in knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
• A thorough understanding of the drug development process from pre-IND through registration and post-registration and a broad understanding of functional areas of drug development, including (preclinical, regulatory, pharmacology, translational medicine, pharmacovigilance, data sciences (data management, biostatistics, programming), and clinical operations is required
• Strong verbal and written communications skills, including an understanding of medical and scientific terminology and the ability to summarize information effectively
• An ability to work collaboratively with team members and stakeholders from different functions.
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., Veeva), J-Review or similar data reporting tools
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.