Sr. Director, Business Operations, Strategic R&D Operations

Who We Are

For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.

And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.

Our Culture

Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.

Summary

This position will lead all business operational activities in support of BioMarin’s emerging and late-stage evidence generation studies in support of brand evolution.  The Senior Director of Strategic Research & Development Business Operations is responsible for overseeing the following:

• Development and management of trial forecasts and budgets in partnership with cross-functional key stakeholders.
• Ongoing collaboration and partnership with the VP of Global Study Execution to ensure appropriate financial line of sight across portfolio of programs.
• Alignment with other Clinical and Scientific stakeholders on understanding early, late-stage and post approval trial strategy to successfully contribute to trial execution.
• Portfolio and program level vendor selection and contracting strategy, including negotiation of scope and budget for proposed vendor services in line with trial assumptions, drivers, and milestones; quantitative analysis of vendor bids and proposals.
• Drafting and negotiating vendor and site contract documents.
• Liaising with cross-functional teams (e.g., Study Teams, Program-level Teams) and Clinical & Medical Sr. Leadership regarding all aspects of financial strategy and management.
• Contributing to vendor performance oversight.

 

The Senior Director will partner with the GVP of Strategic Research & Development Sciences Operations (SRDO) and the SRDO Leadership Team to oversee activities related to the SRDO functional infrastructure. Member of SRDO Leadership and Management Teams. 

Responsibilities

Senior Director, Research & Development Business Operations Responsibilities

Strategic Sourcing:

• Partner with Global Strategic Sourcing (GSS) to identify short and long-term outsourcing needs for BioMarin’s emerging, late-stage and post approval programs and drive portfolio and project level outsourcing strategies.
• Lead operational decision making, including SRDO vendor selection and scoping of outsourcing services required.
• Accountable for decisions on acceptance of key contract terms and all administrative work related to CRO and other third-party vendor contract submissions in accordance with BioMarin policies.
• Oversee contract and financial approvals process in accordance with BioMarin policies.
• Collaborate with Compliance to ensure coordination of vendor audits and relevant follow up activities.
• Ensure proper documentation, archiving and inspection readiness of all vendor selection projects and contracts.

 

 Vendor Contracting and Oversight:

• Support the vendor contracting strategy in support of trial execution across all emerging, late-stage and post approval programs. 
• Partner with GSS, SRDO Business Operations and Study Teams in the review of vendor proposals, including the qualitative analysis and comparison of vendor proposals and budgets in competitive bidding.
• Support the drafting and negotiation of vendor scopes of work and budgets, including communications with vendors and drafting of final contracts.
• Responsible for partnering with key stakeholders to support relationship management and governance of key service providers and contractors (e.g., CROs, FSPs, Central Labs), including participating in lessons learned, governance committees, relationship management and issue mitigation meetings and driving strategic provider relationships.
• Lead the effort to enhance vendor governance and performance oversight and ensure cross functional adherence to processes for complex trial vendor relationships.
• Develop and implement metrics to track contract and financial status and process performance (Key Performance Indicators).
• Attend Key Vendor Executive Oversight meetings to ensure contract and study progress, and critical issues / proposed solutions are identified and tracked to resolution.

 

 Clinical Trial Portfolio Financial Management:

• Partner with Study Teams to establish key assumptions required for the development of study budgets.  Provide ongoing support to Study Teams, Clinical and Medical Teams, Committees (e.g., PRC) in the review and management of study budgets, including internal and external trial costs.
• In partnership with FP&A and SRDO Sr. Leadership, lead the planning and development of the annual operating plan, forecasting exercises and long-range planning of BioMarin’s external study execution expenses.
• Responsible for the financial planning and budgeting of all new studies, including the development of scenario analyses based on outsourcing strategy and trial assumptions.
• Responsible for the business process management of the study financial management platform (BOARD), including internal stakeholder training for the routine study planning, simulation, budgeting and change order planning.
• Responsible for overall vendor contract financial management including adherence to applicable SOPs, implementing CNF process and project related cost controls, leading financial review activities with key vendors and aligning vendors with BioMarin financial processes (budgeting, forecasting).
• Support financial transparency and accountability in vendor and trial site contracting.
• Drive cross-departmental process improvement initiatives relating to external trial spend, such as improving financial reporting of vendor spend, generating and analyzing value earned analyses, developing vendor financial metrics, aligning processes for the PO assignment and GL reporting, supporting protocol development with timely estimates of costs, and improving communication with key stakeholders and clinical and medical senior management.
• Support Clinical & Medical senior management in analyzing program and trial variances, including guiding discussions relating to trade-off decisions, identifying program savings opportunities, and anticipating financial and strategic impact of outsourcing strategy, timing, and trial assumption changes.
• Support the financial oversight of study vendors, including advising key stakeholders of trends and potential financial risks, as well as reviewing financial information for quarterly Executive Oversight Meetings.
• Support Clinical and Medical Sr. Leadership in analyzing project deviations, making trade-off decisions, identifying project savings, and anticipating financial and strategic impact of outsourcing strategy, timing, and clinical assumption changes.

 

Clinical/Medical Contracts and Grants:

• 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. This may include support for Investigator Sponsored/Investigator Initiated & Collaborative trials.
• Drive the timely processing of all trial agreements by closely partnering with internal and external business partners. Identify risks and escalate as appropriate.
• 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 process efficiencies for timely negotiation and execution of all trial agreements.
• Provide ongoing updates to Study Teams regarding trial agreement status, risks & mitigations.

 

Department and Line Management Responsibilities:

• Partner with the GVP of SRDO and the SRDO Leadership Team 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, including more senior level personnel.
• 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 the development and management of the department’s annual operating plan (OPEX), including forecasting and long-range planning.
• Partner with SRDO leadership to deliver on BioMarin’s commitment to Diversity, Equity, and Inclusion (DEI).
• 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 SRDO 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.

 

Other Responsibilities:

• Support various internal steering committees and initiatives.  Support Corporate due diligence activities as needed or requested.

 

 

Experience and Requirements:

A Bachelor’s degree in a scientific, business or financial discipline required.  An advanced degree in a business or financial discipline preferred.

 

• 15 years of prior relevant experience, including a minimum of 6 years of legal or business management experience in the biotech setting.
• Strong working knowledge and experience with managing contracts (vendor and clinical study sites) and finance activities.
• Extensive knowledge of the pharmaceutical/biotech industry.
• Proven ability to build and maintain effective internal and external relationships.
• Basic working knowledge of FDA/GCP and ICH guidelines and other industry regulations to ensure appropriate activities related to world-wide clinical studies.
• Strong working knowledge of Sarbanes-Oxley controls specifically Section 404; OIG and PhRMA code guidelines.
• Basic working knowledge of clinical business technology systems (e.g., CTMS, IXRS, EDC, etc.)
• Excellent written and oral communication skills.
• Experience and confidence working with multiple functional areas and facilitating communication across multiple levels of internal/external teams.
• Demonstrated experience in developing and maintaining excellent organizational skills and prioritizing/balancing multiple projects.
• Resilient to change; can find solutions in challenging environments.
• Composure: can handle stress; doesn’t show frustration when resisted or blocked; is a settling influence in challenging situations; can be counted on to hold things together during tough times.
• Problem Solving: is excellent at honest analysis; can see hidden problems.
• Delegation: comfortably delegates tasks and shares responsibility and accountability.
• Timely Decision Making: makes tough decisions in a timely manner; sometimes with incomplete information and under tight deadlines and pressure.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.