Vice President, Clinical Development

Job Type


Full-time

Description

Corbus is recruiting a Vice President, Clinical Development. This is a senior role focused on a company's clinical development, scientific strategy, and medical affairs. The Vice President, Clinical Development role involves leading clinical programs, ensuring scientific and regulatory compliance, and collaborating across teams to develop therapies. This role 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. This 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. This role will support planning, publication strategy and other tasks. This role provides scientific and operational expertise to ensure patient safety in clinical studies and effective communication of safety to regulatory and ethical bodies. This role works to analyze, summarize and report on safety data. Develops cumulative safety update reports and ensures compliant report of individual safety reports to regulatory bodies and ethical committees. The Vice President, Clinical Development is a qualified physician scientist with exceptional academic clinical trials' experience in Oncology development. They will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage portfolio.

We seek an experienced Vice President, Clinical Development to play a pivotal role in further growing the Clinical Development function at Corbus Pharmaceuticals and leading and contributing to the unique science. This role will offer you a high level of influence and impact on novel therapies by partnering externally with some of the world's leading clinicians in the field of Oncology while collaboratively partnering with our Clinical Development Organization at Corbus Pharmaceuticals. In this position, the Vice President, 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 (including the CMO) and regulatory agencies.


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. Includes contributing to and reviewing of clinical protocols
• Gathers, analyzes and summarized 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
• Represent 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 Pharmaceuticals (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
• Supports with 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 other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues or groups Management/Leadership
• 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 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.
• 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.
• 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.

Requirements

• 10+ years of relevant clinical research/clinical trial experience (must demonstrate a minimum of 5 years of high-level clinical trial experience in pharma/biotech industry) including Oncology programs.
• MD or combined MD/PhD
• 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, which is 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.

Corbus Culture:

Corbus is a close-knit global team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our "family" atmosphere where each person's contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.

About Corbus:

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 and CRB-601, and anti-integrin monoclonal antibody which blocks the activation of TGFß expressed on cancer cells. Additionally, we are developing a cannabinoid receptor-1 (CB-1) inverse agonist as potential treatment for obesity. Corbus is headquarters in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook.

Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer