Job Category: Pharmaceutical & Biotech

Director, Site Contracts (DG)

Job Location: Northern, NJ (see all jobs in NJ)

Work Type: Hybrid

Date Posted: 2022-01-20

Director, Site Contracts (DG)
Northern NJ/NY area (Hybrid)
Pharmaceutical / Biotech

The Director of Site Contracts is responsible for leadership of the oncology and rare disease team of Site Contracts Leads and the day-to-day management of the Functional Service Provider (FSP) for outsourced site budget and contract negotiations. This individual is responsible for helping develop, implement, and lead a new site contracting operational support model and leading the Site Contracts Team and vendor staff responsible for conducting site budget and contract negotiations. The Director of Site Contracts interacts with senior level management, external vendors, collaboration partners, and clinical study personnel.

RESPONSIBILITIES:
Think strategically about the company’s ideal approaches to conducting site contracting and drive solutions, while ensuring compliance. Help develop and implement a new site contracting operational support model, which includes a combination of in-house v. outsourced contracting. Partner with colleagues in the Law Department and other partner groups, as needed, to continuously enhance the operational model and prioritize assignments across assigned therapeutic areas. Maintain key site contracting metrics for vendors and direct reports, ensure that internal systems are updated in a timely, accurate, and complete manner, and maintain an overview of contract statuses and issues, in order to proactively communicate progress, risks, issues or changes that may impact quality, timelines and/or budget. Acts as point of contact for clinical program and study level contract issues. Provides innovative and flexible operational solutions and options to the cross functional and study teams and proactively creates and implements risk mitigation strategies. Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects. Ensures inspection readiness throughout the clinical program lifecycle. Act as the single point of accountability for ensuring that direct reports are meeting performance and efficiency standards and performing in a manger that is consistent with company values. Responsible for ensuring the delivery of high quality, compliant, effective, and timely work product; line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight. Ensure that staff is engaged closely with internal client groups, sites, and various partners and effectively communicating with them, in order to ensure that business objectives are met. Ensure that vendors and staff are conducting issue resolution of moderate to high complexity. Establish team goals that will increase knowledge and skill level (delegate tasks accordingly, commensurate with skill level). Accountable for ensuring consistency of process and approaches across studies. Helps drive decision making and integrates all operational considerations for studies to ensure that contract finalization goals are attainable prior to implementation. Directly accountable for the day-to-day management of the FSP across the portfolio, in partnership with CTM, Strategic Sourcing & Procurement, Study Optimization, and Vendor Management colleagues. Handle site contracting related issues effectively and efficiently. Train the FSP on our templates, tools, and site contracting processes. Assist with resource forecasting and resource allocation for the FSP.

REQUIREMENTS:
Bachelor's degree required. J.D. or MBA preferred. Minimum of 10 years of direct experience with global, Phase I-IV oncology and preferably also rare disease clinical site agreement and budget negotiations (at a biopharmaceutical company, CRO, or site) required, including strong U.S. site negotiation experience. Minimum of 8 years of people management and U.S. site contracting experience required. Minimum of 5 years of experience working with a vendor for global outsourced clinical site contracting. Ability to mitigate and drive solutions regarding investigator site budget and contract negotiation challenges. Ability to identify and implement standard methodologies and contribute to continuous improvement. Strong management and coaching experience. Comfortable leading cross functional teams. Ability to effectively spearhead ongoing process improvements (including cross-stakeholder, critical initiatives). Strong interpersonal & leadership skills. Ability to provide strategic direction and guidance for assigned book of work. An understanding of relevant industry trends. Analytical skills with a data driven approach to planning, executing, and problem solving. Effective communication skills via verbal, written and presentation abilities. Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization. Ability to influence and negotiate. Budget management experience. Ability to build productive teams and collaborations. Strong project management, cross-functional team leadership and organizational skills. Demonstrated vendor management experience. Line management experience with demonstrated mentoring and coaching skills. Extensive experience in global clinical trial operations. May require up to 25% of broader travel.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

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