Director, Clinical Operations

Norwood, MA, United States

Company Description

Corbus Culture:

Our passion. Our purpose. At Corbus, it starts at our core.

We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what's best for patients.

About Corbus

Corbus is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: 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, an anti-integrin monoclonal antibody that blocks the activation of TGF? expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity. 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 a 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. Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.

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.

10+ years experience in pharmaceutical industry and/or clinical research organization, including clinical study/project management/clinical trial management.

Experience of managing clinical programs through phase 1-4.

Metabolic or obesity trial experience

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, budget management, and contingency planning

Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills

Strong communication skills and ability to work with cross-functional study teams

Strong organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities

Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner.

Ability to work independently and act with initiative to address issues

Additional Information

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