What are the responsibilities and job description for the Clinical/Medical Affairs Director, Medical Device position at Kelly Science, Engineering, Technology & Telecom?
Kelly® Science & Clinical is seeking a Director, Clinical Affairs and Medical Affairs for a direct-hire opportunity with our early-stage, innovation-driven Biotech client. If you’re passionate about advancing scientific discovery and ready to elevate your career, trust The Experts at Hiring Experts.
Job Summary
The Director, Clinical Affairs and Medical Affairs will lead the development and execution of clinical evidence generation and scientific engagement throughout the product lifecycle. This critical leadership role drives scientific rigor, operational excellence, and alignment with regulatory and commercial objectives, serving as the clinical and medical lead in the organization.
Key Responsibilities
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Job Summary
The Director, Clinical Affairs and Medical Affairs will lead the development and execution of clinical evidence generation and scientific engagement throughout the product lifecycle. This critical leadership role drives scientific rigor, operational excellence, and alignment with regulatory and commercial objectives, serving as the clinical and medical lead in the organization.
Key Responsibilities
- Clinical Strategy & Study Execution:
- Lead strategies and execution for pre- and post-market clinical programs (including IDE studies, registries, and investigator-initiated studies).
- Design protocols, define endpoints, and align with regulatory/clinical practice expectations.
- Oversee trial execution, CROs, site selection, enrollment strategies, and ensure data quality.
- Manage study timelines, budgets, and program delivery.
- Clinical Evidence Generation:
- Interpret clinical data to support product development and lifecycle management.
- Lead development of abstracts, manuscripts, presentations, and scientific communications.
- Support benefit-risk assessments, indication expansion, and pipeline prioritization.
- Ensure clinical evidence meets regulatory, commercial, and market access goals.
- Medical Affairs & Scientific Engagement:
- Develop global medical affairs strategies for education, adoption, and evidence dissemination.
- Foster relationships with key opinion leaders, investigators, and partners.
- Lead advisory boards and scientific exchange initiatives.
- Cross-Functional & Organizational Leadership:
- Support teams with clinically accurate education and training.
- Align clinical strategy with new product development and global regulatory requirements.
- Collaborate on risk assessments, post-market surveillance, and evidence-based commercial strategies.
- Lead Clinical Affairs team members and manage departmental budgets, processes, and partnerships.
- Foster a culture of scientific rigor, accountability, and collaboration.
- Bachelor’s degree in life sciences, health sciences, clinical research, or related field (required).
- 7 years of experience in clinical/medical affairs in the medical device industry.
- 5 years’ leadership managing teams and complex clinical programs.
- Demonstrated success in leading pre- and post-market clinical studies.
- Experience with FDA and/or EU MDR regulatory environments.
- Advanced degree (MD, PhD, PharmD, or Master’s in clinical science/public health).
- Leadership in interventional, vascular, or image-guided therapies.
- Strong clinical study design and execution capabilities.
- Ability to translate clinical data into strategic decisions.
- Experience engaging physicians and developing KOL networks.
- Disciplined management of multi-site clinical programs and external partners.
- Effective communication and stakeholder management skills.
- FLSA Classification: Exempt
- Job Family: Director, AMD
- Reports To: Sr. VP, Medical Affairs & Medical Director
- Department: Clinical Research
- Physical Demands: Sedentary
- Travel: Up to 40%
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.