Clinical Development Lead

Roche • Indianapolis, IN

2d • $100,500 - $186,700 • Remote

About The Position

At Roche, we foster a culture where 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.

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.

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree