Clinical Operations Country Head - USA

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

At Roche and Genentech Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029

The Opportunity

The Clinical Operations Country Head (CH) provides strategic leadership and is accountable for optimizing country operations to achieve organizational goals. This role leads the Country Leadership Team to drive effective execution of the country's strategic objectives and portfolio, ensuring compliance, resource efficiency, and continuous improvement in collaboration with Clinical Research Organizations (CROs) and may also participate/ lead PDG strategic initiatives. The role focuses on building strong stakeholder relationships to facilitate operations and advance clinical research, while prioritizing talent development and fostering a high-performing team. In hub roles, the position shares accountabilities for affiliated countries, providing strategic and operational guidance. The role may also encompass vendor oversight responsibilities, ensuring effective CRO partnerships, issue resolution, and communication with relevant stakeholders.

1. Leadership and Strategic Direction

• Country Leadership Team: Lead the Country Leadership Team, comprising members with clearly defined accountabilities across key organizational pillars (Oncology/Neurology, IIO, CoE, and APO), to ensure cohesive and effective leadership and decision-making.

• Country Strategy and Portfolio: Accountable for the development, implementation, and delivery of the overall country strategy and portfolio, aligning with global organizational objectives and priorities.

• Strategic Collaboration: Work together with internal stakeholders such as P&C, General Manager (GM), Country Medical Director (CMD), and legal on country-specific, non-TA-specific issues. Partner with other  Country/Area Heads and Global Leaders,  to enhance portfolio delivery and execution across Clinical Operations, ensuring alignment and synergy.

• Global Alignment: Engage with global TA/CoE/APO Leaders, when appropriate, to facilitate effective portfolio delivery, ensuring all activities are conducted in accordance with the global PDG strategy and One Pharma strategy.

• Portfolio Oversight: Maintain comprehensive portfolio awareness, proactively identifying and addressing any in-country priority conflicts to ensure efficient resource allocation and optimal outcomes.

2. Operational Excellence and Compliance

• Local Compliance: Ensure that the country operates in full compliance with all local requirements, including legal, financial, and ethical standards and practices.

• Resource Management: Ensure the efficient and responsible use of resources and budget, maximizing value and minimizing waste.

• Productivity and Efficiency: Identify and implement strategies and tactics in partnership with the CROs to drive continuous productivity and efficiency gains, fostering a high-performing organizational culture.

• Data-driven performance optimisation: Continuously monitor and optimize performance and efficiency with a data-driven mindset, leveraging established KPIs and metrics to measure and enhance country performance.

• Process Improvement and Innovation: Champion and implement process improvements in PDG and in partnership with the CROs to enhance operational effectiveness and streamline workflows.

3. External Stakeholder Management and Relations

• External Stakeholder Management:

  • Build and maintain strong relationships with the CRO partners and external stakeholders, including Health Authorities, Ethics Committees, and Industry Groups, to influence policy and actively drive initiatives to strengthen clinical research within the country.

  • Engage with other relevant external stakeholders, such as Pharma Associations and Institutional stakeholders, to foster positive relationships and achieve mutual objectives.

• Local Environment and Legislation: Maintain a solid understanding of the local environment and legislation governing the conduct of clinical trials in the country, ensuring compliance and effective operations.

4. People Leadership and Development

• By exemplifying our Roche values and Leadership commitments and modeling our Roche Operating Principles, you will ensure we achieve our ambitions for our people and patients. 

• As an experienced People Leader, your accountabilities include:

  • Driving department-wide engagement by fostering a culture of collaboration, inclusivity, and high performance while championing inclusion and belonging. Inspire, motivate, and develop talent within the team, ensuring a focus on individual growth and leadership development to build a strong, elevated talent pipeline aligned with organizational objectives.

  • Regular year-round assessment of performance, contributions, and impact and providing feedback, coaching, and performance management.

  • Manages direct reports, including other people leaders.

  • Leading by example in demonstrating and championing inclusive behaviours in your team, PDG, PD, and the Roche Enterprise. Provide opportunities for growth and development for all team members and address any barriers that may exist.

• People management-related administration (e.g. Workday People & Culture Management system tasks) and contact for employment-related matters.

5. Hub responsibilities (if applicable)

As leader of a hub:  Share accountabilities for affiliated countries belonging to the hub, providing oversight and guidance as required. This will involve providing comprehensive oversight and guidance to ensure alignment with strategic objectives and operational effectiveness. These responsibilities will include: 

• Strategic Direction:  Establishing a clear vision and strategic direction for the hub and affiliated countries, ensuring alignment with overall organizational goals.

• Operational Oversight:  Monitoring and evaluating the performance of affiliated countries, identifying areas for improvement, and implementing corrective actions as needed.

• Resource Allocation:  Optimizing the allocation of resources across the hub and affiliated countries to maximize efficiency and effectiveness.

• Collaboration and Coordination:  Fostering collaboration and coordination between 

6. Role for Vendor oversight (can be delegated to the country CoE Leader) 

• Strong Relationship with your CRO Partners on localized strategy and delivery

• In collaboration with CRO Partner resolve Vendor issues 

• Ensure Country vendor issues are entered into SPOT (service provider oversight tool)

• Oversight of SPOT and Vendor Management Process by Country Study Teams including metrics/KPI reviews

• Escalation to CoE Regional Hub Lead for above study issues for resolution if needed 

• Primary point of contact for CoE Regional Lead insights & metrics

• Share best practices and local insights among the Clinical Sourcing & Partner (CSP) community 

• Support to embed CSP driven innovation and continuous improvement

Who you are

• Degree (MD, PhD, MA/MS or BA/BS) in life sciences or similar area. Postgraduate degree or master’s degree highly desirable.

• 15+ years drug development experience 

• Over 10 years of executive leadership steering the strategic direction and operational complexities in a global enterprise 

• Understanding of end-to-end clinical trial processes, expert knowledge of drug development in the US, including external trends and knowledge of clinical trial regulations and guidelines. 

• Proven ability to foster impactful cross functional collaboration though exceptional communication and influence

• Track record of expanding access to underserved populations

• Frequent national or international travel will be required at times. The amount may vary with the role, location and business needs. 

Preferred Qualifications

• Additional commercial or relevant experience is considered an asset

Relocation benefits are available for this posting

The expected salary range for this position based on the primary location of California is $247,200 - $459,000.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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