Clinical Development Lead

Roche; Tucson (AZ); Hybrid; USD 101,000 - 187,000; Full time

Job summary

Roche is seeking a Clinical Development Lead (Medical & Scientific Writing) to partner with the CEI team and drive clinical evidence generation for cutting-edge IVD programs. You will own end-to-end documentation strategy and lifecycle management for regulatory submissions.

You will design protocols, author CSRs and IVDR documents, review literature, mentor junior staff, and collaborate with Medical Affairs to produce manuscripts and posters. Flexible hybrid work in AZ/USA.

Qualifications

• Doctoral or advanced degree in life sciences or related field
• Minimum 2 years of scientific research and medical writing experience
• Proven publications in peer-reviewed journals

Responsibilities

• Design protocols for novel IVD product development and regulatory filings
• Author and review clinical study documents including CSRs and IVDR reports
• Review literature and synthesize data into regulatory-ready reports
• Manage end-to-end document lifecycle ensuring regulatory compliance
• Collaborate with Medical Affairs and Scientific Communications on manuscripts and posters
• Mentor junior Medical Writing team members

Skills

Scientific writing

Project management

Cross-functional collaboration

Document lifecycle tools

Education

Doctoral or advanced degree in life sciences

Tools

Document lifecycle management

Job 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'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.

The Opportunity

As a Clinical Development Lead (Medical & Scientific Writing), you will serve as a strategic partner within our Clinical Evidence for In-Vitro Diagnostics (CEI) team to drive clinical evidence generation and study design for cutting-edge In-Vitro Diagnostics (IVD). In this role, you will lead end-to-end documentation strategy and lifecycle management to support regulatory submissions and advance patient care across key disease areas including Infectious Diseases, Oncology, and Cardiovascular/Metabolic Diseases.

• Design scientifically sound clinical protocols in close partnership with Subject Matter Experts (SMEs) to support novel IVD product development and regulatory filings
• Author, review, and finalize critical clinical study documents, including protocols, Clinical Study Reports (CSRs), Investigator Brochures, and IVDR Performance Evaluation documentation
• Conduct comprehensive scientific literature reviews and synthesize complex multi-modal laboratory and clinical data into clear, regulatory-ready reports
• Drive end-to-end document lifecycle management, ensuring compliance with internal procedures, quality control standards, and international regulatory requirements
• Partner cross-functionally with Medical Affairs and Scientific Communications to support manuscript, poster, and advisory board content generation
• Mentor junior members of the Medical Writing team, championing process improvements, document automation, and collaborative best practices

Who You Are (Required)

• You hold a Doctoral or advanced degree (e.g., PhD, MD, PharmD) in life sciences, pharmacology, biomedical engineering, biostatistics/epidemiology, or a related clinical research field
• You bring 2+ years of proven scientific research and medical/scientific writing experience in an industry or academic setting, with direct experience authoring clinical protocols and reports
• You possess a strong track record of publications in peer-reviewed scientific journals
• You demonstrate strong organizational, project management, and cross-functional communication skills, with a proven ability to lead multiple complex projects simultaneously
• You are highly proficient in common word processing, document lifecycle management, and collaborative software tools

Preferred

• 3+ years of specialized experience in regulatory/medical writing specifically for In-Vitro Diagnostics (IVD), companion diagnostics, or medical devices
• Demonstrated experience with IVD-Regulation (IVDR) performance evaluation documentation and regulatory agency submission responses
• Familiarity with clinical laboratory techniques including PCR, next-generation sequencing (NGS), immunohistochemistry (IHC), or immunological assays
• Basic understanding of biostatistical methods and clinical trial data evaluation
• Direct experience in project management or mentoring junior team members

Location

• This position may be based out of Tucson (Arizona, USA) or Indianapolis (Indiana, USA) with remote work locations possible
• No relocation benefits are available for this posting

Travel Requirements

• Occasional domestic travel to select conferences or internal meetings

The expected salary range for this position based on the primary location of AZ is $100,500 - $186,700. 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. This position also qualifies for the benefits detailed at the link provided below.

Benefits

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. 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.

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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.