Corbus Pharmaceuticals
Medical Director, Clinical Development
Corbus Pharmaceuticals, Norwood, Massachusetts, us, 02062
Corbus is recruiting a Medical Director, Clinical Development reporting to the Chief Medical Officer (CMO). This senior role focuses on the company's clinical development, scientific strategy, and medical affairs. The Medical Director, Clinical Development leads clinical programs, ensures scientific and regulatory compliance, and collaborates across teams to develop therapies. This role provides scientific expertise necessary to design, implement and interpret data from clinical studies, offers scientific input and oversight, and manages cross‑functional execution of clinical studies in collaboration with Clinical Operations. The role will be responsible for the scientific aspects of 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. The role supports the Chief Medical Officer in planning, publication strategy and other tasks. This role offers a high level of influence and impact on novel therapies by partnering externally with some of the world’s leading clinicians in Oncology and Immunology while collaborating within Corbus Pharmaceuticals. In this position, the Medical Director, Clinical Development provides critical analysis of safety data and translates complex scientific information into clear, compliant, and well‑structured reports and documentation for senior leadership and regulatory agencies.
Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly.
Responsibilities
Leads and/or participates in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance including contributing to and reviewing clinical protocols.
Gathers, analyzes and summarizes data and information necessary to create the CD plan; may also delegate such research and analysis to less experienced Clinical Scientists.
Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment and participates in competitive intelligence assessments.
Represents Clinical Development in collaboration with Research and Translational Sciences for alignment on biomarker strategy and pharmacological assessments – Clinical Development Plan Implementation.
Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by Corbus (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.).
Supports completion and submission of regulatory filings and other regulatory documentation.
Oversees the review, analysis and reporting of clinical data in collaboration with biometrics and data management to enable clinical decision making and regulatory filings.
As needed/appropriate, collaborates with others in the review of safety narratives and other safety‑related guidelines and documentation.
Where assigned, acts as the primary CD liaison/point‑of‑contact from the team for inquiries from Clinical Operations, Clinical Research Organizations (CROs), etc.
Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and coordinates submissions to scientific meetings.
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.
Evaluate innovative trial designs in collaboration with Head of Operations and Chief Medical Officer.
Co‑lead cross‑functional clinical trial working groups, collaborating with Clinical Operations and external 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.
Identify study and program‑wide issues by reviewing and monitoring emerging clinical data related to safety, efficacy and PK/PD; develop sound, strategic solutions to issues and collaborate with the clinical study team to ensure issue resolution.
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.
Offer strategic and scientific contributions to the overall clinical development pipeline and documentation strategy.
Qualifications & Experience
MD or combined MD/PhD.
10+ years of relevant clinical trial experience, including a minimum of 5 years of high‑level clinical trial experience in the pharmaceutical/biotech industry.
The ability to communicate complex scientific and medical information clearly and accurately is critical.
A deep understanding of life sciences, medical terminology, and clinical trial processes is essential, often gained through an M.D. or other advanced science degree.
Familiarity with the requirements and processes of regulatory agencies is crucial for authoring submissions.
The ability to interpret and present complex scientific and statistical data is a core skill.
Corbus is an oncology and obesity company committed to helping people defeat serious illness by bringing innovative scientific approaches to well‑understood biological pathways. Corbus’ internal development pipeline includes CRB‑701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin‑4 on cancer cells to release a cytotoxic payload, CRB‑601, an anti‑integrin monoclonal antibody which blocks the activation of TGF‑β expressed on cancer cells, and a cannabinoid receptor‑1 (CB‑1) inverse agonist as a potential treatment for obesity. Corbus is headquartered in Norwood, Massachusetts.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Science
Industries
Biotechnology
Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr
Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly.
Responsibilities
Leads and/or participates in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance including contributing to and reviewing clinical protocols.
Gathers, analyzes and summarizes data and information necessary to create the CD plan; may also delegate such research and analysis to less experienced Clinical Scientists.
Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment and participates in competitive intelligence assessments.
Represents Clinical Development in collaboration with Research and Translational Sciences for alignment on biomarker strategy and pharmacological assessments – Clinical Development Plan Implementation.
Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed by Corbus (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.).
Supports completion and submission of regulatory filings and other regulatory documentation.
Oversees the review, analysis and reporting of clinical data in collaboration with biometrics and data management to enable clinical decision making and regulatory filings.
As needed/appropriate, collaborates with others in the review of safety narratives and other safety‑related guidelines and documentation.
Where assigned, acts as the primary CD liaison/point‑of‑contact from the team for inquiries from Clinical Operations, Clinical Research Organizations (CROs), etc.
Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and coordinates submissions to scientific meetings.
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.
Evaluate innovative trial designs in collaboration with Head of Operations and Chief Medical Officer.
Co‑lead cross‑functional clinical trial working groups, collaborating with Clinical Operations and external 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.
Identify study and program‑wide issues by reviewing and monitoring emerging clinical data related to safety, efficacy and PK/PD; develop sound, strategic solutions to issues and collaborate with the clinical study team to ensure issue resolution.
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.
Offer strategic and scientific contributions to the overall clinical development pipeline and documentation strategy.
Qualifications & Experience
MD or combined MD/PhD.
10+ years of relevant clinical trial experience, including a minimum of 5 years of high‑level clinical trial experience in the pharmaceutical/biotech industry.
The ability to communicate complex scientific and medical information clearly and accurately is critical.
A deep understanding of life sciences, medical terminology, and clinical trial processes is essential, often gained through an M.D. or other advanced science degree.
Familiarity with the requirements and processes of regulatory agencies is crucial for authoring submissions.
The ability to interpret and present complex scientific and statistical data is a core skill.
Corbus is an oncology and obesity company committed to helping people defeat serious illness by bringing innovative scientific approaches to well‑understood biological pathways. Corbus’ internal development pipeline includes CRB‑701, a next generation antibody drug conjugate (ADC) that targets the expression of Nectin‑4 on cancer cells to release a cytotoxic payload, CRB‑601, an anti‑integrin monoclonal antibody which blocks the activation of TGF‑β expressed on cancer cells, and a cannabinoid receptor‑1 (CB‑1) inverse agonist as a potential treatment for obesity. Corbus is headquartered in Norwood, Massachusetts.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Science
Industries
Biotechnology
Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr