12 дней назад
Director Clinical Development & Medical Affairs (MedTech)
180 000 - 243 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director Clinical Development & Medical Affairs (MedTech): Leading global clinical development and medical affairs for healthcare products, shaping evidence strategies, clinical studies, claims, and portfolio decisions with an accent on scientific rigor, regulatory compliance, and real-world evidence. Focus on building clinical capabilities, overseeing pre-market and post-market studies, developing external clinical networks, and translating evidence into defensible product claims.
Location: Hybrid in Libertyville, Illinois, US; minimum four days per week in the office
Salary: $180,000–$243,000 yearly, plus eligibility for the corporate bonus plan
Company
is an independent, employee-owned healthcare products company developing, manufacturing, and marketing products for ostomy care, continence care, and critical care worldwide.
What you will do
- Lead the global Clinical Development and Medical Affairs organization and establish its strategic direction.
- Build evidence roadmaps for products, platforms, and therapy areas, including clinical questions, outcomes, endpoints, and study sequencing.
- Own pre-market and post-market device studies, including protocols, statistical approaches, investigators, sites, budgets, timelines, CROs, and data quality.
- Develop real-world evidence capabilities using registries, observational studies, patient-reported outcomes, secondary data, and post-market clinical follow-up.
- Partner with R&D, Marketing, Regulatory, Legal, Human Factors, Market Access, and New Ventures to develop clinically meaningful and defensible claims.
- Build clinical networks, guide KOL and advisory board strategy, set publication and congress plans, and represent in scientific forums.
Requirements
- Bachelor’s degree and 12–15 years of related experience.
- Experience building or substantially strengthening evidence strategies, not only executing studies.
- Experience designing and overseeing pre-market and post-market device studies through completion.
- Working command of GCP, ISO 14155, FDA, and EU MDR clinical requirements.
- Experience with real-world evidence, clinical claims, peer-reviewed publications, or changes in clinical practice.
- At least 3 years of people leadership experience and the ability to engage with clinicians, researchers, and senior business leaders.
Nice to have
- MD, PhD, PharmD, DNP, advanced nursing or clinical degree, MS, or MPH combined with deep clinical development experience.
- Experience with products used in chronic care or other patient-managed conditions.
Culture & Benefits
- Hybrid work environment with regular office collaboration in Libertyville.
- Medical, prescription, dental, vision, disability, life, wellbeing, and spending or savings account benefits.
- Paid parental and caregiver leave, statutory leave programs, paid holidays, vacation, and sick days.
- 401(k) retirement savings plan with auto-enrollment, Roth contributions, vesting, and eligible safe-harbor matching contributions.
- Education assistance, adoption assistance, voluntary benefits, and corporate bonus eligibility.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
13 дней назад
Director, Medical Publications and Scientific Communications (Biotech)
208 000 - 269 000$
12 дней назад
Director, Clincial Operations (Clinical Operations)
12 дней назад
Executive Director, Clinical Pharmacology/Pharmacometrics
287 980 - 346 060$
12 дней назад
Global Safety Medical Director, Rare Disease
25 660 650 - 34 717 350$