SciPro has been retained by a subsidiary of a VC backed biologics incubator to hire a Senior Manager/Associate Director Clinical Operations.

This position will work closely with their CSO and CMO as well as VP of Preclinical Development on their antibody pipeline. The biotech start up has 2 programs (mAb, BsAbs) that includes a Phase Ib rheumatoid arthritis trial.

They are seeking someone to oversee and manage clinical trials across early development phases in their autoimmune pipeline. The ideal candidate will have a strong background in study start-up activities and extensive experience in managing Contract Research Organizations (CROs) to ensure efficient and successful trial execution.

Responsibilities:

Study Start-Up Management:

• Lead and oversee all aspects of study start-up activities, including site selection, investigator meetings, protocol development, and regulatory submissions.
• Ensure timelines are met for site initiation, patient recruitment, and enrollment.
• Collaborate with cross-functional teams to develop study plans and strategies.

CRO Management:

• Manage relationships with CROs and other external vendors to ensure adherence to timelines, budgets, and quality standards.
• Provide oversight and guidance to CROs throughout the trial lifecycle, including contract negotiation, performance management, and issue resolution.
• Conduct regular meetings and reviews to assess CRO performance and ensure alignment with project goals.

Clinical Operations Oversight:

• Implement and execute clinical trial protocols, ensuring compliance with ICH/GCP guidelines, SOPs, and regulatory requirements.
• Monitor trial progress, identify risks, and develop mitigation strategies.
• Manage clinical trial budgets, forecasting, and resource allocation.

This is a role that requires someone to independently manage the CRO. You need to have experience doing this previously at a small biotech company.

Qualifications:

• Bachelors degree in science, advanced degree optional
• 3-5 years industry experience. Need to have worked at a small biotech previously
• Proven experience in managing clinical trials from start-up through close-out phases.
• Extensive experience in managing CROs and other external vendors.
• Biologics experience is a nice to have
• Autoimmune experience is preferred

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