Study Start-Up Lead

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

Are you ready to shape the clinical trial landscape in Mexico and accelerate life-saving therapies for patients in Oncology, Neuroscience, and Cardiometabolic diseases?

At Roche Global Clinical Operations (PDG), we unite leading science and technology to transform patients' lives. As a Study Start-Up Lead, you will drive strategic country-level site activation, transforming regulatory complexity into streamlined trial delivery. Join an inclusive, high-performing culture where your strategic leadership directly accelerates time-to-patient for innovative medicines.

The Opportunity

• Lead country start-up strategy to achieve rapid site activation across high-impact therapeutic areas.
• Shape the local clinical environment by engaging with Ethics Boards, Health Authorities, and CRO partners.
• Pioneer process automation and continuous improvement to eliminate operational bottlenecks.
• Work in an agile, matrixed global network where continuous learning and personal development are prioritized.

Responsibilities

• Architect and execute country study start-up strategies and proactive risk mitigation plans.
• Oversee regulatory submission packages, Digipris/COFEPRIS workflows, and Single Ethics Committee processes.
• Strategically manage site documentation, ICF management, and clinical trial contract/budget negotiations.
• Act as the primary strategic point of contact for global study teams, local investigators, and CROs.
• Provide functional leadership, mentoring, and developmental guidance to Study Start-Up Specialists.

Who you are

• You hold a University Degree (BA/BS, MS, PhD) in Life Sciences or a related field.
• You bring 4+ years of solid experience in clinical trial operations, study start-up, or regulatory submissions in Mexico.
• You possess deep expertise in Mexican regulatory frameworks (COFEPRIS, Ethics Committees, Digipris) and ICH-GCP guidelines.
• You demonstrate proven independence, strong problem-solving skills, and the ability to prioritize under pressure.
• You are fully fluent in written and spoken English and Spanish.

Preferred

• Experience managing CRO relationships and therapeutic expertise in Oncology, Neuroscience, or Cardiometabolic trials.

Relocation benefits are not available for this position.

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.