Medical Director, Clinical Development

Corbus Pharmaceuticals Inc•Norwood, MA

18d•Hybrid

About The Position

Corbus is recruiting a Medical Director, Clinical Development reporting to the Chief Medical Officer (CMO). This is a senior role focused on a company's clinical development, scientific strategy, and medical affairs. The Medical Director, 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 the Chief Medical Officer in 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 with the Chief Medical Officer 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 Medical Director, Clinical Development is a qualified physician scientist with exceptional academic clinical trials' experience, preferably in Oncology development. The Medical Scientist 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. Reporting to the Chief Medical Officer (CMO), we seek an experienced Medical Director, 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 and Immunology while collaboratively partnering with our Clinical Development Organization at 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 (including the CMO) and regulatory agencies. Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly.

Requirements

MD or combined MD/PhD
5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience clinical research roles within the pharmaceutical industry. 10+ years of relevant clinical trial experience (must demonstrate a minimum of 5 years of high-level clinical trial experience in pharma/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, 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.
The ability to interpret and present complex scientific and statistical data is a core

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 as documented in
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.