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he Director of Medical Affairs is responsible for creating and driving Coloplast’s agenda in the North American clinical community, with the objectives of driving understanding of and evidence for Coloplast products; and being a liaison to the scientific community.

They will do this by defining near, medium and long‑term objectives, covering a broad range of medical affairs activities, such as:

• Developing a clinical roadmap to support the value proposition across Coloplast’s Chronic Care portfolio.
• Driving acceptance of Coloplast product claims in the clinical community through the generation of clinical evidence, earning their endorsement and resulting in guideline enhancements.
• Identifying external clinical opinions, perceptions and trends that influence Coloplast performance in North America, and where warranted, develop appropriate mitigating strategies.
• Building and managing expert HCP relationships, facilitating their interest in Coloplast products.
• Engaging key professional groups (e.g., AUA, WOCN, etc.) and establishing strong relationships that enhance our corporate image, as well as increase understanding of Coloplast products.
• Establishing and driving a scientific agenda in North America, by engaging researchers through Coloplast activities and grants, including where appropriate, conducting clinical studies that lead to publications in support of Coloplast business objectives.
• Partner with key internal stakeholders in North America, and globally, to drive stronger alignment of clinically appropriate strategies at Coloplast.

Ideal candidates will have both strong clinical research and commercial understanding. They will have a proven track record of developing and implementing programs that have delivered true business impact. Finally, the ideal candidate has a background in medical/scientific affairs from within the medical device industry or similar (either from the pharma or biotech industries).

• Taking clear leadership of the Medical Affairs function
• Building, and leading, the Medical Affairs team to deliver on department goals.

• Defining clinical direction and building clinically relevant evidence for providers substantiated by advisory boards, market research and clinical research.
• Engaging key professional groups (e.g., AUA, WOCN, etc.) to identify opportunities to influence clinical guidelines that define standard of care relevant to Coloplast Chronic care products and services.
• Identifying external clinical opinions and trends that influence Coloplast commercial performance in North America, and where warranted, developing appropriate mitigating measures and evidence.

• Monitoring trends and discovering and sharing 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.
• Driving publications of data to ensure relevant content at medical congresses and at Coloplast events.
• Partnering with cross functional teams to create and execute a North American clinical publication plan supporting the Coloplast value proposition to external stakeholders in North America, such as clinicians, Home Health Agencies, GPOs, payors, government organizations, patient advocacy groups, etc.

• Creating ambassadors and expert HCP partnerships in alignment with clinical direction including:
• Defining HCP thought leader plan, strategy and segmentation.
• Facilitating expert participation in symposia.
• Managing customer advisory panels allowing for quick HCP access.
• Managing relationships with key opinion leaders engaged in clinical research activities to ensure alignment and compliance with all federal and company policies.
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Other job duties as assigned.

• Master’s or Doctoral degree in a clinical field
• 7+ years’ experience working in a clinical research capacity
• 2 years’ experience managing a team including clinicians
• International and domestic travel required up to 25%
• Strong ability to review and interpret scientific data and research
• Demonstrated ability to work across functions to prioritize and drive strategic objectives
• Excellent oral and written communication skills
• 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

• Advanced degree (e.g., PhD, MD, RN, MPH) in a technical discipline (e.g., medicine, science, nursing)
• Previous experience in a leadership role responsible for clinical research and publications
• Knowledge of US clinical practices related to patient care for ostomy, intermittent catheterization and bowel management in patients with neurogenic bladder and/or bowel.

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation: The compensation range for this position is $172,000 - $256,000. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

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.