The Medical Affairs Sr. Program Manager is responsible for driving evidence strategies, and executing Coloplast agenda in the clinical community.
The Chronic Care business at Coloplast has products to help patients with intimate healthcare needs. The patient population spans spinal cord injury, cancer, Multiple Sclerosis, spina bifida, and many more.
The candidate will do this by covering a broad range of medical affairs activities, such as
- Driving acceptance of Coloplast product claims through publications and strategic evidence dissemination
- Developing and executing evidence roadmaps consisting of pre-clinical and clinical data, patient reported outcomes, case studies, consensus studies, literature reviews, etc.
- Interpretating published and new evidence, summarizing it in a form suitable for education of healthcare professionals, payors, and government agencies
- Cultivating relationships with Key Opinion Leaders (KOLs) to shape the clinical agenda resulting in guideline and medical policies enhancement
- Identifying external clinical opinions, perceptions and trends that influence Coloplast performance in the US, where warranted, executing appropriate mitigating strategies
Ideal candidates will have a strong ability to interpret clinical and real-world evidence, business acumen and KOL influence skills. The ideal candidate has broad range of evidence generation experiences from within the medical device industry in the US.
Major Areas of Accountability
- Partner with US and global cross functional teams to identify business priorities and lead evidence strategy development
- Leverage literature, regulations, and guidance to build and execute on evidence strategies
- Drive execution of new evidence, including study design, data interpretation and publications to ensure relevant content is presented at medical congresses and at Coloplast events
- Partner with global cross functional teams, including Medical Affairs to identify research and publication opportunities using new and existing data
- Develop and maintain KOL network able to support Coloplast evidence generation, advocacy, and education needs
- Support preparation for Coloplast meetings with government agencies, such as FDA, CMS, etc. and commercial payors by providing medical expertise, leveraging KOL networks, preparing evidence summaries and presentations
- Inform and shape outcomes of medical advisory boards as applicable
- Provide medical expertise for novel ideas, questions and information requests related to Chronic Care products
- Monitor trends and share new clinical evidence that address unmet needs (i.e. improved clinical, financial or patient satisfaction outcomes) substantiated through medical congresses, expert networks and library searches
- Define priorities and ensure milestones are achieved for all initiatives. Communicate regularly with stakeholders on project progress and risks to achieving milestones
- Strong understanding of Coloplast products and therapies, relevant anatomy, and accepted applications and uses associated with our products
- Financial budget modeling and scenario planning around evidence needs
- Monitoring project progress for timely intervention and problem solving
- Understanding of the compliance requirements, best practices accepted in the market and competitive space
- Master’s or Doctoral Degree in a technical discipline (e.g., medicine, science, nursing)
- 8+ years’ experience working in a medical device or health policy
- 5+ years of clinical or outcomes research experience
- International and domestic travel required up to 25%
- Clinical or Advanced degree (e.g., RN, NP, PA, PhD, MD, MPH) in a technical discipline (e.g., scientific, clinical or engineering)
- Knowledge of US clinical practices related to patient care for intermittent catheterization, ostomy and/or bowel management in patients with neurogenic bladder and/or bowel
- Understanding of payors evidence requirements
- Experience with digital data collection and analysis of patient reported outcomes
Required Knowledge, Skills, And Abilities
- Strong ability to review and interpret scientific data and outcomes research
- Demonstrated ability to work across functions to prioritize and drive strategic objectives
- Excellent oral and written communication skills
- Excellent project management and organizational skills
- An understanding of trial design
- High degree of initiative and self-motivation with a strong sense of accountability
- Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence
- Aptitude to successfully prioritize and manage multiple tasks while adhering to deadlines
- Adaptability to realign initiatives quickly to meet shifts in the market
- Microsoft Word, Excel, PowerPoint proficiency required
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.
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Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.