Country Clinical Operations Excellence Leader

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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The Position

Purpose, Objectives and Scope of Position

As a Country Clinical Operations Excellence (CoE) Leader in PDG, you will be pivotal in driving portfolio-wide improvements and boosting clinical trial delivery productivity. This position involves fostering innovative trial execution, tackling critical needs, and collaborating with key stakeholders across PDQ, pRED, gRED, USM, and PDMA. You will lead and shape initiatives to implement new operational models with both internal and external partners, ultimately impacting clinical trial delivery.

Key Responsibilities

● Develop the strategy and implementation plan of CoE initiatives that support PDG's business objectives.

● Oversee the execution and governance of initiatives within global PDG Clinical Operations and with external stakeholders.

● Collaborate with various stakeholders across the enterprise internally and externally such as Study Teams, PDQ, Countries, pRED, gRED etc., to ensure strategic alignment and drive innovation.

● Stay ahead of external learning trends, technologies, and best practices to enhance learning and knowledge management programs and maintain PDG's competitive edge.

● Impact Measurement: Communicate the outcomes of CoE initiatives, such as improved operational efficiency, enhanced decision-making, increased employee engagement, and accelerated innovation.

Quality and Compliance:

● Leads in creation, improvement and implementation of enhanced global and local processes, policies, and training programs to drive efficiency, standardization, and a strong compliance culture both internally and with our CRO partners/vendors. Ensures maintenance of global and local regulatory compliance (GCP/GVP/IxD/GMP), oversees audit support and corrective action management, safeguards data quality and integrity, leads the development and monitoring of interventional trial compliance (AMCO/global), and acts as a key liaison with regulatory authorities.

Business Process:

● Drives the implementation and management of defined clinical operations business processes, ensuring adherence to standards and procedures. Monitors process performance, identifies areas for improvement, and collaborates with stakeholders including CRO partners to implement necessary changes.

Learning Management:

● Architect and lead a forward-thinking learning management strategy for Clinical Operations, encompassing both internal and CRO partner training oversight, focused on building future capabilities through innovative learning solutions.

● Drives efficiency and empowers decision-making by ensuring timely access to critical information, thereby ensuring the organization remains at the leading edge of clinical trial execution.

Knowledge Management:

● Architects and drives a strategic Knowledge Management framework, deliberately integrating advancements in AI to fuel innovation, operational efficiency, and ensure real-time access to critical information for data-driven decision-making, maintaining Clinical Operations as a leader in these fields.

● Orchestrates the timely adoption and full embedding of cutting-edge AI technologies and knowledge management tools, strategically leveraging data to optimize operational efficiency, enhance outcomes, and establish Clinical Operations as an influential innovator in knowledge management and AI application.

Country Clinical Operations Excellence:

● Responsible for local clinical operations excellence, encompassing vendor oversight, compliance strategies/oversight for interventional trials, and change management, all while ensuring alignment with global CoE and regulatory standards. Act as a primary liaison between various stakeholders, including CRO partners, regulatory authorities, and internal teams (ex medical compliance), and contributes to strategic planning and continuous improvement initiatives, including potentially country leadership and people management.

Qualifications

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

● Significant experience in the pharmaceutical or related industry more than 7 years.

● Experience in product development is essential to familiar with up and down-stream end-to-end process.

● Knowledge of end-to-end clinical trial processes, and strong knowledge of clinical trial regulations and guidelines.

Skills and competencies:

● Fluency in written and spoken English is mandatory.

● Strategic Thinking : Demonstrates proficiency in strategic planning, with a strong ability to analyze complex information, identify key relationships and dependencies, and formulate effective long-term plans. Exercises sound judgment in selecting optimal courses of action based on rigorous logical analysis, factual evidence, resource availability, situational constraints, and alignment with organizational values.

● Delegation and Empowerment : Effectively identifies and leverages opportunities to accelerate results and foster team development by strategically assigning tasks and decision-making responsibilities to individuals and teams. Ensures clarity by establishing clear boundaries, setting explicit expectations, providing necessary support, and implementing consistent follow-up mechanisms.

● Leadership : Exhibits strong leadership capabilities, with the ability to inspire, motivate, and guide individuals and teams towards achieving common goals. Demonstrates a proactive approach to fostering a positive and productive work environment.

● Communication : Possesses excellent communication skills, both written and verbal, enabling clear, concise, and effective conveyance of information to diverse audiences. Adept at active listening and adapting communication styles to suit different situations.

● Customer Centricity : Demonstrates a strong customer-centric mindset and behaviors, focused on building positive, productive, and sustainable relationships with both internal and external stakeholders. Prioritizes understanding and meeting customer needs and expectations.

● Adaptability and Prioritization : Exhibits a high degree of adaptability, with the ability to effectively manage multiple priorities and operate successfully in a fast-paced, dynamic, and evolving environment. Demonstrates strong prioritization and time management skills.

● Collaboration : Possesses exceptional collaboration skills, with a proven ability to work effectively within cross-functional teams and cultivate strong, collaborative relationships with colleagues and partners.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.