Director of Clinical Affairs
Apply NowCompany: Monica Burt & Associates
Location: Plano, TX 75025
Description:
Job Description
We're looking for a visionary leader to shape the future of clinical strategy as our Director of Clinical Affairs. If you're ready to step into a high-impact, executive-facing role that directly influences the trajectory of a fast-growing medical device powerhouse, this one's for you.
Here's what you'll be doing:
Requirements
12+ years in clinical research, with 5+ years leading at the executive level-bonus points for ortho device experience!
A Bachelor's in Life Sciences, Engineering, or a related field (Master's, PhD, or MBA = even better).
A proven track record of running global clinical programs, especially post-market studies.
Sharp strategic instincts, regulatory expertise, and stellar communication skills.
Certifications like CCRA, CCRC, or RAC (preferred but not required).
Benefits
A seat at the decision-making table with the CEO and executive team
A chance to shape the clinical future of a growing med device innovator
A company culture built on purpose, innovation, and impact
Competitive compensation, equity options, and top-tier benefits
Flexible work options with a home office day each week
We're looking for a visionary leader to shape the future of clinical strategy as our Director of Clinical Affairs. If you're ready to step into a high-impact, executive-facing role that directly influences the trajectory of a fast-growing medical device powerhouse, this one's for you.
Here's what you'll be doing:
- Define and lead a global clinical strategy that aligns with our game-changing products and corporate vision.
- Collaborate closely with our CEO and executive team to make bold, informed decisions that move the needle.
- Build and inspire a high-performing Clinical Affairs team focused on excellence, innovation, and outcomes.
- Own regulatory readiness-from EU MDR to FDA submissions-and be our trusted liaison with regulatory bodies.
- Drive clinical innovation by integrating emerging tech like AI, digital health, and robotics into study design and evidence generation.
Requirements
12+ years in clinical research, with 5+ years leading at the executive level-bonus points for ortho device experience!
A Bachelor's in Life Sciences, Engineering, or a related field (Master's, PhD, or MBA = even better).
A proven track record of running global clinical programs, especially post-market studies.
Sharp strategic instincts, regulatory expertise, and stellar communication skills.
Certifications like CCRA, CCRC, or RAC (preferred but not required).
Benefits
A seat at the decision-making table with the CEO and executive team
A chance to shape the clinical future of a growing med device innovator
A company culture built on purpose, innovation, and impact
Competitive compensation, equity options, and top-tier benefits
Flexible work options with a home office day each week