Director - Clinical Affairs at Caldera Medical

100% ONSITE - Westlake Village, Ca

Visa Sponsorship not offered for this role

Message from the Hiring Manager:

I’m excited to share that we are opening a new position for a Clinical Director to join our team. This role will be pivotal in shaping and leading our clinical strategy, ensuring excellence in study execution, and driving compliance with global regulatory requirements.

We are looking for a strong leader with deep experience in clinical research and medical device/biopharma environments, who can balance strategic vision with hands-on execution. The ideal candidate will bring both scientific expertise and operational leadership to help us advance our portfolio and deliver meaningful outcomes for patients.

This is an exciting opportunity to make a significant impact during a critical stage of our growth. If you or someone in your network is interested, please reach out to our Talent Acquisition team or apply through the careers page.

Duties and Responsibilities:

• Develop and lead the clinical strategy and clinical deliverables (CEP, CER, SSCP, etc.) to support regulatory approvals, reimbursement, and market adoption.
• Advise executive leadership on clinical development risks, opportunities, and competitive landscape.
• Oversee design, planning, and execution of clinical studies (feasibility, pivotal, post-market).
• Ensure trials are designed to meet regulatory, reimbursement, and scientific requirements.
• Select and manage CROs, investigators, and clinical sites.
• Monitor enrollment, trial progress, and ensure studies are conducted within scope, budget, and timelines.
• Ensure compliance with Good Clinical Practice (GCP), ISO 14155, and local/international clinical trial regulations.
• Develop strategies for peer-reviewed publications, conference presentations, and clinical evidence dissemination.
• Build relationships with Key Opinion Leaders (KOLs) and advisory boards.
• Oversee vendor selection and management (CROs, data management, monitoring organizations).
• Ensure patient safety through clinical risk management.
• Oversee post-market clinical follow-up (PMCF) and registries, especially under EU MDR requirements.
• Ensure compliance with Good Clinical Practice (GCP), ISO 14155, and local/international clinical trial regulations.

Required Knowledge, Skills and Abilities:

• BS life sciences, nursing, biomedical engineering or related.
• 10 years clinical research experience in med device, pharma or biotech.
• 3 years in leadership role.
• Experience managing multiple studies.
• Strong understanding of regulatory requirements.
• Data-driven leader

Travel – up to 25% international travel required

Competitive Compensation, Comprehensive Benefits, and more!

• Annual Salary - $170k-$190k along with bonus eligibility!
• Medical and Dental Benefits – 75% paid for employee and family members
• Vision Coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 10 paid holidays- including your birthday!
• Being surrounded by amazing people!

(This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.)

Our Culture- Where Career and Passion come together!

• A Culture of family and team… not a corporate goliath where you’re just another number.
• All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Who is Caldera Medical?

Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.