Executive Director, Development Sciences Business OperationsLocation San Rafael, California Apply
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 and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
This position will lead all business operational activities in support of BioMarin’s global clinical development programs. The Executive Director of Development Sciences Business Operations is responsible for overseeing the following:
- Development and management of clinical trial forecasts and budgets in partnership with key stakeholders.
- Alignment with other Global Clinical Development (GCD) stakeholders on understanding clinical trial strategy in order 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 clinical trial assumptions, drivers and milestones; quantitative analysis of vendor bids and proposals.
- Drafting and negotiating vendor and clinical site contract documents.
- Liaising with Study Execution Teams and GCD Sr. Leadership regarding all aspects of financial strategy and management.
- Contributing to vendor performance oversight.
The Executive Director will partner with the VP of Development Sciences Operations (DSO) and the DSO Leadership Team to oversee activities related to the DSO functional infrastructure. Member of DSO & GCD Leadership and Management Teams.
- Partner with Global Strategic Sourcing (GSS) to identify short and long-term outsourcing needs for BioMarin’s global clinical development programs and drive portfolio and project level outsourcing strategies.
- Lead operational decision making, including GCD 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 & Development Sciences Quality 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 across all global clinical development programs.
- Partner with GSS, Business Operations and Study Execution 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 GCD service providers and contractors, 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 clinical trial vendor relationships.
- Develop and implement metrics to track contract and financial status and process performance (Key Performance Indicators).
- Attend CRO Executive Oversight meetings to ensure contract and study progress, and critical issues / proposed solutions are identified and discussed with the CRO.
Clinical Trial Portfolio Financial Management:
- Partner with Study Execution Teams to establish key assumptions required for the development of clinical study budgets. Provide ongoing support to Study Execution Teams in the review and management of clinical study budgets, including both investigator grants and external trial costs.
- In partnership with FP&A and GCD Sr. Leadership, lead the planning and development of the annual budget, forecasting exercises and long-range planning of BioMarin’s external clinical development expenses.
- Responsible for the financial planning and budgeting of all new studies, including the development of scenario analyses based on outsourcing strategy and clinical trial assumptions.
- Lead the alignment effort between Corporate Finance and various functions within GCD in developing clinical trial cost variance analyses.
- Responsible for management of the clinical 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 clinical trial site contracting.
- Drive cross-departmental process improvement initiatives relating to clinical 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 GCD senior management.
- Support GCD 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 clinical trial assumption changes.
- Support the financial oversight of clinical vendors, including advising key stakeholders of trends and potential financial risks, as well as reviewing financial information for quarterly Executive Oversight Meetings.
- Support GCD 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 Contracts and Grants:
- Responsible for overseeing the drafting and negotiation of clinical trial agreements and budgets, partnering with the Study Execution Teams and Legal to ensure alignment for corporate and department goals achievement.
- Drive the timely processing of all CTAs by closely partnering with internal and external business partners. Identify risks and escalate as appropriate.
- Work with key stakeholders within Business Operations to enhance clinical study budget templates and process plans, ensuring they meet corporate compliance guidelines.
- Responsible for the development and maintenance of metrics for global CTA execution.
- Responsible for developing 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 clinical trial agreements.
- Provide ongoing updates to Study Execution Teams regarding CTA status, risks & mitigations.
Department and Line Management Responsibilities:
- Partner with the VP of Development Sciences Operations and the DSO Leadership Team to develop department goals to achieve established Corporate and GCD goals within the expected timeframes.
- Successfully implement new DSO initiatives.
- Manage Development Sciences Business Operations staff, including more senior level personnel (e.g., Directors, Sr. Directors).
- 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 annual department budgets (OPEX), including forecasting and long range planning.
- Embody the Clinical Development Core Values and provide leadership in demonstrating these values through everyday actions and behaviors.
- 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 DSO 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.
- Support various internal steering committees and initiatives. Support Corporate due diligence activities as needed or requested.
Experience & Education
- 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; strong knowledge of research and development.
- 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.
- Decision Making: Make sound and effective decisions. Move forward in an effective manner without being distracted by factors outside of one’s control. Be decisive and move to action in the absence of clear information, data a pre-existing process or precedent.
- Influence and Collaboration: Seek the perspective of others. Partner with others across and outside the organization to define and reach a shared goal. Persuade
- by effectively sharing information. Influence based on credibility and earning the respect of others, rather by title or level.
- Agility: Recover constructively from setbacks, while continually learning and modifying approach. To be impactful and nimble, in stressful and suboptimal conditions. Adapt to circumstances and change course when and where appropriate.
- Leadership: Lead, develop and manage high performing teams effectively. Set vision and purpose through goals and clear authentic communication. Attract, develop and retain industry-leading talent.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.