Director, Clinical Operations

Company Description

Corbus Culture:

Corbus is a close-knit 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 a precision oncology 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 TGFβ expressed on cancer cells. Corbus is headquartered 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

Job Description

We are seeking an Director, Clinical Operations to provide strategic leadership and operational planning expertise to Corbus Pharmaceuticals clinical development programs. We are looking for an experienced Clinical Program Manager who can lead the creation and high-quality implementation of thoughtful clinical develop plans.  This position is both a member of the Core Team and an integral co-leader responsible for the effective operations of the Clinical Sub-team, facilitating cross-functional engagement both internally and with vendor partners as part of a fully outsourced operating model. We are open to candidates who are based in greater Boston area for a hybrid role and candidates based remote willing to travel monthly to Norwood, Ma office.

Responsibilities:

• Providing operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for assigned clinical program(s); may lead some trial management activities within assigned program as well.
• Providing program-level sponsor oversight of CRO and 3rd party vendors to ensure the effective execution of the clinical studies on time, with high quality (e.g., inspection ready) and within agreed budget.
• Collaborating with cross-functional counterparts to oversee the performance for all activities assigned to our CROs and vendors, including escalation of issues when necessary.
• Clinical program budget planning and external spend related to clinical program execution. Working closely with CROs and vendors, Program Management and Finance to ensure that budgets, enrollment, and forecasts are accurate.
• Reviewing and providing expert clinical operations input into clinical documents including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis and protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; may be responsible for the management of clinical document creation or updates.
• Providing expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate.
• Functional leadership which may include line management, providing input for issue resolution and leading and/or support functional strategic initiatives and process improvement.

Qualifications

Knowledge and Skills:

• Bachelors Degree or international equivalent required, Life Sciences preferred.
• 15+ years experience in pharmaceutical industry including clinical study/project management/clinical trial management.
• Experience of managing oncology clinical programs through phase 1-4.
• Oncology experience strongly preferred.
• Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
• Extensive experience managing complex protocols, CROs, budgets, and timelines
• Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• Ability to competently manage multiple competing priorities, adapting as needs change. Must be comfortable working in a fast-paced environment.
• Demonstrated excellence in program management, including scenario assessment, risk assessment, bud