
201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
đĽ 23 hours ago
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201 - 500 employees
đ Pharmaceuticals
đĽ Healthcare
đź Consulting
Pharmaceuticals ⢠Healthcare ⢠Consulting
Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.
⢠Develop and execute the long-term strategic vision for the Medical Affairs division with the CMSO ⢠Own the operating budget and P&L for Medical Monitoring and Pharmacovigilance ⢠Build capability roadmaps for Medical Monitoring and Pharmacovigilance ⢠Represent Medical Affairs on the Operational Leadership Team and advise the CMSO on medical, scientific, and safety risks ⢠Drive collaboration across Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Scientific Affairs, and Business Development ⢠Provide executive oversight of medical monitoring across Indero's clinical trial portfolio ⢠Lead physician resourcing, including hiring, training, deployment, and performance management ⢠Maintain medical monitoring SOPs, work instructions, and quality standards ⢠Escalate complex or high-risk medical monitoring issues and sponsor-facing medical disputes ⢠Provide strategic and operational oversight of pharmacovigilance, including case processing, signal detection, aggregate reporting, and regulatory submissions ⢠Ensure compliance with global and country-specific pharmacovigilance obligations ⢠Lead readiness for PV regulatory inspections and internal audits ⢠Partner with sponsors on PVAs and SDEAs ⢠Partner with Business Development on RFPs, client presentations, bid defenses, pricing, and new business ⢠Serve as senior medical point of contact for key sponsor accounts ⢠Represent Indero in scientific and industry forums ⢠Ensure Medical Affairs compliance with regulations, the QMS, and sponsor requirements ⢠Own Medical Affairs SOPs, quality plans, CAPA plans, and audit/inspection responses at executive level ⢠Lead, mentor, and develop the multidisciplinary Medical Affairs team ⢠Establish workforce planning, career pathing, succession planning, leadership development, performance frameworks, and KPIs
⢠Medical doctor (MD, DO, or equivalent international medical degree) required ⢠12-15 years of progressive experience in the pharmaceutical, biopharmaceutical, or clinical research industry ⢠5-7 years in a leadership role within a CRO, pharmaceutical company, or hybrid organization ⢠Demonstrated experience leading and scaling Medical Monitoring and Pharmacovigilance functions ⢠Proven track record of client engagement in a commercial, revenue-generating environment ⢠Deep expertise in global clinical trial regulatory frameworks ⢠Meaningful exposure to multiple therapeutic areas ⢠Experience with health authority interactions, regulatory inspections, and audit defense ⢠Experience managing P&L or budget responsibility ⢠Board certification in dermatology or rheumatology is an asset but not required ⢠Advanced business training (e.g., MBA) is an asset but not required ⢠Working knowledge of PV safety databases and safety reporting automation tools ⢠Exposure to AI-assisted technologies in medical monitoring, PV, or medical writing workflows ⢠Published authorship of peer-reviewed scientific manuscripts or presentations at major clinical/scientific conferences ⢠Multilingual capability or international regulatory experience ⢠Ability to legally work in North America ⢠Willingness to travel frequently
⢠Competitive compensation with performance incentives ⢠Full benefits ⢠Attractive advancement opportunities ⢠Stimulating work environment ⢠Remote role with frequent travel
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