New · posted Nov 6
Roche · Medical Devices
Global Clinical Program Lead
- Pleasanton, CA
- On-site
- Full-time
- Senior & Principal
The role
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.
- You will ensure proactive alignment with LCT (Life Cycle Teams) / PT (Project Teams), medical/clinical, evidence generation, and execution strategies within CDMA.
- You will drive planning, development, and delivery of evidence generation programs with full accountability for the program progress, budgets, timelines, strategic scenario assessments, and proactive program risk management in partnership with cross-functional stakeholders, including LCT Project Leads, Regulatory Affairs, R&D (Research & Development), Pharma Partners, and other CDMA chapters.
- Drive the development of the Integrated Evidence Generation Plan for the products in scope in partnership with internal and external stakeholders.
- Ensure adequate allocation of resources by collaborating with the Functional Partner (FP) and Sub-Chapter Leads (SCL), through timely communication of demands and skill set requirements in alignment with priorities of the respective CDMA Networks and Project Teams.
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.
What you need
- You have a Bachelor’s degree or an advanced degree in Life Sciences and/or relevant expertise in the healthcare industry, a related field, or equivalent relevant experience. Experience in diabetes care is a must, background in multiple disease areas is a plus.
- Generally 10+ years of experience in diagnostics, medical device biotechnology and/or pharmaceutical clinical trials with responsibilities for managing all major aspects of strategic planning, design, organization, implementation, and delivery of clinical programs.
- Understands, applies good knowledge of, and ensures adherence to ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, Bfarm, NMPA regulations, etc across the respective programs to ensure objectives are met in support of CDMA and/or Diagnostics goals.
- You are able and willing to travel up to 25% (can vary/month/program)
Knowledge, Skills and Abilities
- Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first.
- Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity.
- Working across Clinical Development and Medical Affairs communities to identify mutual value and opportunities for collaboration.
- Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial.
- Leverage excellent verbal and written communication skills (English).
- Model Roche’s values of integrity, courage, and passion and We@Roche Diagnostics (culture, mindset and behaviors) in everything you do.
Relocation benefits are not available for this job posting.
This position also qualifies for the benefits detailed at the link provided below. Benefits
Pay and benefits
$146,600 a year
Employer providedThe expected salary range for this position based on the primary location of Pleasanton, CA is $146,600 - 272,200 USD Annual. 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.
Discretionary annual bonus
Benefits package (details via link)
Where you'll work
Pleasanton, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Pleasanton, CA
From the posting
About Roche
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.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Equal opportunity, accessibility and legal noticesRoche's statements, word for word
Roche 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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $146,600 | — | $146,600 |
This role: Roche's own published range.
Career trajectory
Where this role sits in Clinical Project Management
The general path across 39 open Clinical Project Management roles on Regulatory Jobs, with the titles they carry most. Not Roche's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Clinical trial conduct2
- GMP and compliance1
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Project Management work in medical devices, led by the four this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices RegulationNamed in the posting
- NMPAChina NMPA(official source, opens in a new tab)China's National Medical Products AdministrationNamed in the posting
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
Company hiring pulse
Roche on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 4
- Locations
By discipline
- Regulatory3 50%
- Clinical2 33%
- Quality1 17%
By level
- VP & Executive2 33%
- Manager2 33%
- Senior & Principal2 33%
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Global Clinical Program Lead at Roche
Open until filled. $147K a year, employer provided.