Country Clinical Operations Lead at F. Hoffmann-La Roche Ltd - Poland

Auckland, Auckland, New Zealand -

Full Time

Start Date

Immediate

Expiry Date

19 May, 26

Salary

0.0

Posted On

18 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Leadership, Strategic Direction, Study Management, People Management, Stakeholder Management, ICH GCP, GPP Standards, Budget Forecasting, Clinical Operations, Therapeutic Areas, Data Generation, Team Development, Coaching, Vendor Management, CRO Management, Regulatory Compliance

Industry

Biotechnology Research

Description

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. The Position A healthier future. It is 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 is what makes us Roche. Reporting to the Country Medical Director, Roche Pharmaceuticals NZ (RPNZ) is looking for a Country Clinical Operations Lead (CCO Lead) who provides leadership, strategic direction and oversight for all study, people and stakeholder management activities conducted by their department. They do this in accordance with the appropriate quality standards including ICH/GCP & GPP standards, Roche SOPs, local operating guidelines and local requirements including legal and financial standards and practices. The CCO Lead directly leads and manages an affiliate clinical operations team that is responsible for all local-study management activities and actively participates in local License to Operate Chapter meetings, and as appropriate global and regional meetings. In addition to the local focus, CCO Lead also contributes to the global CCO Function as applicable. Key responsibilities include: Develops the strategy and drives implementation of regional and local tactics for Clinical Operations to meet both long-term and annual goals as cascaded from global function(s) or local affiliate. Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline. Provides input and/or drives the prioritization exercise (planning phase) of the local Disease Area Plans. Accountable for ensuring departmental budget forecasts are accurately produced and submitted in time for the functional budget rounds. Ensures adherence to budget forecasts. Contributes to local and/or global and/or regional initiatives aimed at increasing quality and delivery of clinical operations activities (globally, regionally and locally). Accountable for the execution of all data-generating activities (studies) conducted in the Affiliate, including all Roche sponsored and supported, interventional and non- interventional trials Accountable for meeting country study commitments, in line with agreed country goals (budget, quality, patient recruitment and timelines) or where it’s not possible, timely discussions are held with the study project team (global or local) and mitigating actions put in place. Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture. Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with Roche policies and country legislation. Develops and maintains excellent relationships and interactions between the Clinical Operations team, License to Operate Chapter, and other global, regional and local functions. Embraces a customer centric mindset. Who You Are: Master’s/Doctorate degree, preferably in life sciences or other scientific area, with extensive experience of all phases of clinical development, preferably in more than one major R&D-based global pharma company or large CRO. Comprehensive knowledge of ICH GCP, local regulations and all aspects of clinical operational management. Strong understanding of NZ clinical ecosystem and a “business development” mindset with established contacts within CROs, ministry of health, key figures in healthcare ecosystem shaping, etc. Solid track record of selection and management of CROs and other vendors as applicable. Able to articulate long-term strategies and objectives and provide clarity and focus on key priorities. Able to clearly articulate complex concepts and encourage direct and open discussions about important issues. Actively participates in affiliate Big Room Planning, the Roche People Practices, including annual goals supporting impact and contribution, development goals for your future, regular check-ins, and self-assessment of performance. Contributes to the development/maintenance of a positive company culture. Encourages a feedback culture, open communication and cross-functional collaboration Actively engages and collaborates with the wider Roche networks and with key customers as required. Adheres to company (both local and global) policies and procedures at all times, including Health & Safety requirements. This role is only open to candidates that have full eligibility to live and work in New Zealand. We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team. What we offer Roche offers rewarding growth opportunities, a competitive remuneration package and a collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders. Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients. Take pride in knowing you can make a difference to millions of patients worldwide in developing diagnostics and treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, respiratory disease and diabetes. We are committed to providing an inclusive, safe, secure and healthy workplace, and to minimise any such impacts to our employees, customers and the community. We welcome applications from all people and encourage you to advise of any individual circumstances that may require consideration. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Country Clinical Operations Lead provides leadership, strategic direction, and oversight for all study, people, and stakeholder management activities within the department, ensuring adherence to quality standards like ICH/GCP and local regulations. Key duties include developing and implementing clinical operations strategy, managing the local team, ensuring accurate budget forecasting, and being accountable for the execution and timely delivery of all local data-generating activities.