Study Start-Up Lead
Notify me about similar jobsRoche has closed or removed this posting -- see current similar openings below.
About this opportunity
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.
Job details
How this role compares
Computed from every other active Clinical Research role in our database, not just this employer's listings.
We currently track 127 comparable Clinical Research roles across 20 biopharma companies.
Salary context
19 of 127 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 127 comparable roles
+ 24 more countries
Seniority mix
82 of 127 peers have a known seniority level
Therapeutic area mix
11 of 127 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Currently open similar roles
This posting is closed, but here are live openings closest to it -- ranked by similarity, not by how well you'd qualify for them.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.