Director, Clinical Outsourcing and Finance

Corbus Pharmaceuticals Inc•Norwood, MA

About The Position

The Director of Clinical Outsourcing and Finance will be responsible for leading the clinical outsourcing function, including the selection, contracting, oversight, and performance management of external partners. The role also includes responsibility for clinical financial planning and analysis, including developing financial plans, forecasting, budgeting, and evaluating the key drivers that impact financial performance. As a key member of the cross-functional development team, this individual will build scalable outsourcing and procurement processes appropriate for a growing biotechnology company. The role requires a strategic, commercially minded leader who is equally comfortable developing long-term sourcing strategies and personally leading vendor selection, contract negotiations and supplier governance. The primary objective of the role will be to drive value through outsourcing including vendor strategy, governance and financial planning and analysis. Working closely with the Chief Operating Officer, Clinical Operations, Medical, Biometrics, Regulatory, Quality, Legal and the VP, Finance, the Director will establish high-performing external partnerships that enable efficient, cost-effective and high-quality clinical trial execution.

Requirements

Bachelor's degree in Life Sciences, Business, Procurement or a related discipline.
8-10 years prior experience in outsourcing and finance within biotechnology, pharmaceutical or CRO industry.
Demonstrated success selecting, negotiating and managing complex clinical service providers.
Demonstrated ability in Financial Planning and Analysis.
Proven ability to operate effectively in a fast-paced, resource-conscious environment.
Strong understanding of global clinical development and outsourced clinical operations.
Excellent commercial negotiation and contract management skills.
Experience developing supplier governance frameworks.
Strong financial and analytical capability.
Strong attention to detail and ability to manage multiple priorities.
Knowledge of GCP, ICH guidelines and vendor oversight requirements.
Excellent communication, influencing and stakeholder management skills with demonstrated business insights and process impact in previous roles.
Ability to balance strategic thinking with operational execution.
Highly organized, adaptable and comfortable working in an evolving, fast-paced environment.
Advanced Microsoft Excel skills are a must.

Nice To Haves

CPA and/or MBA desirable.
MCIPS or equivalent procurement qualification is advantageous but not essential.
Experience supporting Phase I-IV clinical trials across multiple therapeutic areas is desirable.
Experience working within a small or mid-sized biotechnology company is highly desirable.

Responsibilities

Develop and implement the Company's outsourcing strategy to support clinical development from early through late-stage studies.
Advise senior leadership on outsourcing models, vendor capabilities, market trends and commercial opportunities.
Build an outsourcing framework that is scalable as the organization grows.
Balance quality, timelines, cost and operational risk when making sourcing recommendations.
Lead sourcing activities for CROs, central and specialist laboratories, imaging providers, eCOA/eClinical vendors, specialist service providers and other clinical suppliers.
Support Chemistry, Manufacturing, and Controls (CMC) with vendor selection and contract management as necessary
Develop and manage RFIs, RFPs and vendor selection processes.
Perform commercial and operational assessments of prospective vendors.
Recommend supplier selection based on capability, quality, experience, delivery and value.
Negotiate competitive commercial arrangements while protecting the Company's interests.
Ensure contracts appropriately allocate operational and financial risk.
Partner with Procurement and Finance team to finalize Master Service Agreements, Statements of Work, Change Orders and related contracts.
Work with Functional Leads to establish and maintain strong relationships with strategic suppliers.
Develop supplier governance processes including KPIs, business reviews and performance monitoring.
Drive proactive issue resolution and continuous improvement initiatives.
Work collaboratively with functional teams to ensure vendors consistently deliver to expectations.
Develop annual financial plan and long-range clinical plans
Perform financial return analysis for new development programs to assist in capital allocation
Review and sign off on all clinical vendor bills ensuring financial accuracy and compliance with contractual terms
Identify opportunities for efficiency and cost optimization without compromising quality or timelines.
Contribute to the continuous improvement of fit-for-purpose procurement policies, templates and standard operating procedures.
Introduce practical systems and tools that support vendor oversight and reporting.
Ensure processes remain proportionate for a growing biotechnology organization.
Ensure outsourced activities comply with GCP, GxP and applicable regulatory requirements.
Partner with Quality Assurance on vendor qualification and oversight activities.
Identify and mitigate supplier risks, including quality, financial, operational and business continuity risks.
Maintain inspection and audit readiness relating to outsourced activities.
With a dotted-line reporting relationship to the VP of Finance build trusted relationships across Finance, Legal, Clinical Operations, Medical, Regulatory, Biometrics, and Quality to support effective clinical outsourcing, financial planning, and cross-functional decision-making.
Provide commercial leadership during study planning and program execution.
Influence decision-making through sound commercial judgement and data-driven recommendations.
Act as a trusted advisor to senior leadership on outsourcing strategy.