Senior Director, Clinical Development and Medical Affairs

Cynosure, LLCWestford, MA
$260,000 - $290,000

About The Position

The Sr. Director, Global Clinical Development & Medical Affairs is responsible for leading Cynosure Lutronic's global clinical organization and driving the company's clinical evidence strategy across the entire product lifecycle. This executive oversees all aspects of clinical development, medical affairs, investigator engagement, publications, clinical education, and evidence generation—from early feasibility studies through post-market research—to ensure the company's innovations are supported by robust clinical evidence and translated into physician adoption and commercial success. As the company's senior clinical leader, this individual partners closely with R&D, Marketing, Regulatory Affairs, Quality, Commercial, and Executive Leadership to shape product strategy, guide evidence generation, build global clinical partnerships, and strengthen Cynosure Lutronic's position as the trusted scientific leader in energy-based devices. The ideal candidate combines deep scientific expertise with exceptional organizational leadership, building and developing a world-class global clinical organization that delivers operational excellence while advancing innovation, physician confidence, and patient outcomes.

Requirements

  • Bachelor’s degree required
  • 15+ years relevant experience
  • 15+ years of progressive experience in Clinical Development, Medical Affairs, Clinical Research, or related leadership roles within the medical device or healthcare industry.
  • 5+ years of experience leading global clinical organizations and multidisciplinary teams.
  • Demonstrated success overseeing international clinical studies across the full product lifecycle.
  • Extensive knowledge of FDA, MDR, ISO 14155, GCP, and global clinical research regulations.
  • Experience engaging and managing HCP investigators, clinical sites, and KOL relationships in the context of clinical research or evidence generation programs.
  • Experience in Dermatology, Plastic Surgery, Medical Aesthetics, or Energy-Based Devices.
  • Proven ability to influence executive leadership and lead complex cross-functional initiatives.
  • Executive leadership and organizational development
  • Medical Affairs and scientific communications
  • KOL engagement and stakeholder management
  • Strategic planning and business acumen
  • Exceptional communication and executive presentation skills
  • Strong analytical, organizational, and problem-solving abilities
  • Ability to influence across complex global matrix organizations
  • Sit; use hands to finger, handle or feel objects, tools, or controls.
  • Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.

Nice To Haves

  • Master’s degree preferred
  • Advanced clinical or scientific degree (MD, DO, PhD, PharmD, NP, PA, MPH, or MS) strongly preferred.

Responsibilities

  • Develop and execute the Company's global Clinical Development and Medical Affairs strategy in support of innovation, regulatory, and commercial objectives.
  • Lead and continuously evolve a high-performing global clinical organization, fostering a culture of scientific excellence, collaboration, innovation, and operational rigor.
  • Establish global clinical governance, operating standards, quality systems, and best practices across all clinical activities.
  • Develop organizational capabilities, succession planning, and talent development within the Clinical Development organization.
  • Own the Company's global clinical evidence roadmap across the entire product lifecycle.
  • Oversee the planning and execution of early feasibility, pilot, pivotal, post-market, and real-world evidence studies.
  • Ensure clinical investments are aligned with portfolio priorities, business strategy, and unmet clinical needs.
  • Guide clinical study design, protocol development, endpoint selection, statistical planning, and evidence-generation strategy.
  • Provide scientific leadership across product development and commercialization.
  • Lead the development of clinical evidence strategies supporting product claims, regulatory submissions, publications, physician education, and commercial differentiation.
  • Ensure medical integrity and scientific accuracy across clinical, educational, and commercial initiatives.
  • Monitor emerging clinical trends, treatment paradigms, and competitive technologies to inform innovation and evidence strategies.
  • Build and maintain a global network of Key Opinion Leaders (KOLs), investigators, academic institutions, and professional societies.
  • Oversee physician engagement activities including advisory boards, investigator meetings, scientific roundtables, speaker development, and research collaborations.
  • Foster long-term strategic partnerships that strengthen the Company's clinical leadership and accelerate physician adoption.
  • Partner with R&D, Marketing, Regulatory Affairs, Quality, Commercial, and Executive Leadership to align clinical evidence generation with business, innovation, and commercialization priorities.
  • Provide strategic clinical leadership across product development, regulatory submissions, product launches, and lifecycle management.
  • Ensure clinical evidence supports product differentiation, physician adoption, and commercial success.
  • Lead, develop, and mentor a high-performing global Clinical Development and Medical Affairs organization.
  • Oversee departmental budgets, resource planning, clinical operations, and portfolio execution to ensure projects are delivered with scientific rigor, operational excellence, and regulatory compliance.
  • Establish performance metrics, governance processes, and continuous improvement initiatives to optimize organizational effectiveness and clinical execution.
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