Director, Site Contracts Lead, Strategic R&D Business Operations

Location:  San Rafael, California Category: Clinical

Description

Who We Are

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

SUMMARY DESCRIPTION:

 

The Associate Director/Director, Site Contracts Lead, Business Operations, reporting to the Executive Director, Functional Head of Business Operations, is a key member of the Business Operations leadership team and will be responsible for managing and overseeing all day-to-day activities related to global clinical site contracts and payments for BioMarin. Specifically, this position will be accountable for efficient and effective planning and delivery of site budgeting and contracting activities across a portfolio of clinical programs to time, cost, and quality in close coordination with Global Study Operations, Legal and Procurement.  The role will be responsible for driving continuous process improvements in all aspects of contract management, budget development, and oversight of external vendors negotiating contracts on BioMarin’s behalf.  The Site Contracts Lead will be responsible for leading, developing, and overseeing a team of Business Operations staff in the planning and execution of a range of site contracting responsibilities. Moreover, the Site Contracts Lead will partner with the Business Operations Functional Head and Leadership Team on resource planning and is responsible for talent acquisition, development and resource management across a portfolio of programs, expertise centers, and initiatives.

Department and Line Management Responsibilities

  • Partner with the Business Operations Leadership Teams to develop department goals to achieve BioMarin’s Corporate and WWRD goals as appropriate within the expected timeframes.
  • Successfully implement new SRDO projects or initiatives.
  • Manage SRDO Business Operations staff.
  • Accurately evaluate/project department staffing needs and provide appropriate training and mentoring of staff. Ensure all staff have annual goals established and individual development plans in place.
  • Responsible for ensuring compliance with BioMarin SOPs and guidelines, including Sarbanes-Oxley 404, OIG guidelines and PhRMA code, applicable FDA regulations, current ICH/GCP guidelines, all other applicable laws, or guidelines.
  • Partner with Business Operations leadership and other cross-functional key stakeholders to identify and develop efficient systems and tools for enhancing department efficiency.
  • Establish and maintain highly collaborative internal and external relationships to achieve program goals and objectives.

 

 

Site budget and contracting management, oversight, and issue resolution

 

  • Responsible for overseeing the drafting and negotiation of trial agreements and budgets, partnering with the Study Teams and Legal to ensure alignment for corporate and department goals achievement.
  • Drive the timely processing of all trial agreements by closely partnering with internal and external business partners. Identify risks and escalate as appropriate.
  • Develop, implement and oversee processes to ensure efficient and quality negotiation and execution of site agreements by CROs and other external vendors. Serve as the primary point of contact and responsibility for the performance of CROs in the area of site contracting.
  • Work with key stakeholders within SRDO Business Operations to enhance study budget templates and process plans, ensuring they meet corporate compliance guidelines.
  • Responsible for the development and maintenance of metrics for global trial contract execution.
  • Responsible for overseeing the development of investigator grant budgets and supporting documents according to protocol specifications, ensuring fair market value requirements are met.
  • Collaborate with Legal team to identify and enhance template and process efficiencies for timely negotiation and execution of all trial agreements.
  • Provide ongoing updates to Study Teams and Senior Leadership regarding trial agreement status, risks & mitigations.
  • Serve as the primary point of escalation for resolution of issues related to study site budgeting, contracting and payment activities.
  • Employ a program or portfolio view of clinical cost / spend.  Utilize historical and benchmarking information to address areas of concern or identifies opportunities for optimizing site selection and spend​.
  • Advise study teams on decisions of site selection, considering the legal and financial impact of protocol defined services, geography, investigator site costs and budget constraints
  • Establish a team focus on accuracy of data, diligence in root cause analysis and clarity in communication of financial content and legal analysis
  • Proactively lead the investigation and resolution of complex financial and contract issues; engage appropriate cross functional stakeholders in solution development
  • Demonstrate deep understanding of the sponsor - investigator relationship and leverage knowledge to ensure optimal CTA terms and conditions are established
  • Drive contract structuring discussions, applying legal concepts and considerations, and implementation of guidelines for change requests and amendments

 

 

Education:

 

  • BA/BS in finance, accounting, health sciences, or related degree. Advanced degree preferred. Experience in lieu of education is considered.

Experience & Key Competencies

 

  • 10+ years of relevant experience working in the pharmaceutical industry (including CROs);

 

  • 7+ years of relevant technical experience working within Clinical Operations or within Business Operations, including experience with clinical site and/or vendor contracts and budgets;

 

  • Expertise in site contracting and budgeting process in the US and RoW,

 

  • Experience using Grantplan or other clinical trial benchmarking software

 

  • People management experience

 

  • Demonstrates ability to effectively lead a multidisciplinary team;

 

  • Demonstrates productivity and initiative;

 

  • Ability to plan, prioritize, and organize work timelines, resources, and tasks to support timely execution;

 

  • Excellent written and oral communication skills;
  • Experience and confidence collaborating with multiple functional areas and facilitating communication across multiple levels of internal/external teams to drive solutions;

 

  • Demonstrates commitment to business ethics;

 

  • Demonstrates resilience to change; can find solutions in challenging environments;
  • Effective problem-solving skills; full analysis; searches for hidden problems

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.