Clinical Affairs Director (Part-Time Consultant)

A medical device company in the Midwest is seeking a part-time Clinical Affairs Director (Consultant) to support ongoing and upcoming sponsored studies, while also advising executive leadership on broader clinical and medical affairs strategy. This role will work closely with a lean internal team, providing both hands-on guidance for study execution and high-level strategic input to the VP and CEO.ResponsibilitiesClinical Study Support (Primary Focus)Provide oversight and guidance across:Clinical study design and design promotionProtocol development and optimizationStudy start-up, site activation, and enrollment strategyStudy execution and cross-functional alignmentSupport two key sponsored studies:Head & Neck Study (Close-Out Phase):Drive manuscript development and publication strategyLower Extremity Device Study (Start-Up Phase):Support site activation (starting in ~1–2 months)Guide pilot study sequencing and investigator-initiated trialsStrategic & Advisory SupportAct as a senior clinical/medical affairs advisor to leadershipPartner with VP and CEO on:Rebuilding medical affairs strategy and structurePatient access and market development strategyClinical evidence generation planning through 2027–2028Provide input on:SOP development and process improvementsHEOR and future investigator-initiated trials (IITs)Clinical/regulatory alignment across programsQualificationsDirector or Senior Director-level experience in Clinical Affairs (medical device)Strong expertise in:Clinical study design, protocol development, and executionStudy start-up, site activation, and study managementAbility to operate at both:Strategic level (C-suite collaboration)Tactical level (study execution support)Experience mentoring junior team members and influencing cross-functional teamsExperience with:Wearable chronic compression devices (highly preferred), or Respiratory devices (Candidate should not default to a Class III implantable device mindset)Prior experience supporting:Manuscript development and publication strategyInvestigator-initiated trials and evidence generation planning