Job Description
We have a new opportunity for an Executive Director, International Business Strategy and Operations within our Regulatory Affairs International organisation to be based in London, Kings Cross.
The Executive Director International Business Strategy and Operations will report to the Vice President, Regulatory Affairs International (RAI) and will offer consultative, strategic leadership and will be responsible for the operational delivery which will be critical in the ongoing transformation of our company’s Regulatory Affairs International (RAI) and the wider Global Regulatory Affairs Clinical Safety (GRACS) organisations.
- Reporting to Vice President, Regulatory Affairs International and with leadership responsibility for:
- cross-GRACS leadership of high-visibility and high-impact ex-US focused strategic, transformative cross-divisional operating model, organisation and business programmes
- cross-GRACS leadership of ex-US focused collaborations in areas of corporate priority in markets of key strategic importance
- Regulatory Affairs International-wide leadership and strategic oversight and coordination across all regions for key cross-divisional collaborations and innovative initiatives with Commercial divisions
- Provide strategic management of RAI organisation operations
- Offering outstanding strategic insights and lead cross-functional teams to deliver complex programs
- Develop strategy and deliver operationally across the RAI and GRACS organisations
- Effectively lead and motivate a team of highly-qualified business professionals to ensure delivery on both strategy and operational activities
- Work closely across Global Regulatory Affairs Clinical Safety functional areas and with cross-divisional partners in Commercial division, Finance and HR Business Partners to support delivery of strategic and operational plans
Driving Organisation Effectiveness and Transformation
- Understand regulatory, clinical development, payer and commercial launch strategies spanning pipeline programs plus launch, growth and mature products and ability to translate into implications for the RAI and broader GRACS organization and operating model
- Provide strong cross-GRACS leadership on high-visibility and high-impact ex-US focused strategic, transformative cross-divisional operating model, organisation and business corporate programs
- Lead complex cross-regional projects across the ex-US Regulatory Affairs organisation, coordinating all across GRACS functional areas and cross-divisional partners where needed
- Lead the delivery of high-quality and insightful business data analytics to support delivery of complex projects, operating model and organisation changes
- Work closely with RAI and GRACS leadership teams to ensure that RAI and broader GRACS strategic changes are delivered effectively and efficiently support and scale to clinical development, regulatory approvals and commercial objectives across the ex-US regions
- Work in conjunction with other Business Strategy & Operations teams and similar other capabilities both from GRACS and other divisions to implement new operating models
Operational Management
- Deliver industry-leading human resources models and capacity management capabilities within RAI, including leading analysis of people and resource plans for business development deals and key strategy and innovation programs (such as digital transformation, strategic alliances)
- Work closely with HR and Finance Business Partners to deliver RAI budget and headcount plans on target, with accountability for making decisions
- Informing HR and Finance regarding reallocations, reprioritizations and trade-off’s across countries, regions and headquarter-based RAI teams
- Organise and coordinate Operating Reviews for RAI and GRACS at country and regional level, and with cross-divisional partners, with accountability for driving key changes required
- Lead the preparation of high-quality presentations for both internal and external audiences
- Ensure the strategic effectiveness and focus on key priorities for RAI and regional leadership teams spanning Europe, Middle East & Africa, Canada, Latin America and Asia Pacific incl. China and Japan, plus centralised global headquarter capabilities supporting ex-US regions
Project Management, Planning and Execution
- Working with the Leadership Team to identify, recruit and engage members of the strategic working groups; ensuring relevant skills are aligned to support delivery of the strategic objectives
- Work with Commercial and Manufacturing division leaders across the regions to ensure filing plans for must-win programs are understood, communicated and deliverables met
- Work closely with relevant members of the Finance and HR plus teams from Manufacturing and Commercial divisions teams to support effective implementation of annual and long-range planning formal objectives; providing help define, shape and provide relevant inputs into Scorecards on key strategic priorities, resourcing and financial commitments
- Lead the project management of key deliverables for RAI
- Lead the management and production of RAI scorecards, goals and dashboards, and ensure the ongoing effective communication of filing plans and progress on other strategic priorities to key ex-US regional and global senior leadership stakeholder groups across all divisions
- Lead the development, implementation and tracking of key metrics and other KPIs for the RAI and broader GRACS organisation outside the US
- Contributing to the delivery of the strategic objectives through direct involvement/delivery of key tasks and objectives
Qualifications, Skills & Experience Required
- Degree or equivalent experience
- Significant (min 10 years) experience within the Biopharmaceutical industry
- Significant (min 15 years) experience of working in a business advisory role
- Experience of advising senior leaders (Vice President and Senior Vice President level) within Regulatory Affairs and Safety
- Experience of leading Regulatory Affairs and Safety on key strategic corporate projects, including delivery and interaction at highest corporate leadership levels
- Experience of working with multiple stakeholders across R&D, Commercial and Manufacturing, and across multiple Regulatory Affairs and Safety functional areas, with a track record of driving successful implementation on complex cross-divisional programs
- Track record of strategy and implementation of transformational innovation, operating model and organisation initiatives and change programs for Regulatory Affairs and Safety functions
- Experience of leading a global Business Strategy & Operations capability and team for a large Regulatory Affairs and Safety organisation is highly desirable
- Experience of working within a large, diverse multi-region / multi-country organisation
- Experience of working in-country in different geographic locations is highly desirable
- Track record of excellence in operational organisation management for a large organization (budget, headcount)
- Excellent analytical insights and communications skills
Closing date: Friday 4th August 2023
Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our company, we’re inventing for life.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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Current Contingent Workers apply HERE
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
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Hazardous Material(s):
Requisition ID:R250726