Senior Director, Clinical Science & OMA

This position is responsible for managing the global Clinical Science and Medical Affairs department. This role will provide leadership for clinical strategy, clinical trial execution and all medical affairs related activities required for regulatory submission and marketing trials on approved marked products.

Major Areas of Accountability

• Manage and direct all activities of the Global IU Clinical and Medical Affairs Department.
• Define clinical strategy and scope of responsibilities of Global IU Clinical and Medical Affairs Department.
• Oversee development and adherence to budget and milestones.
• Responsible for hiring, training, development and supervising of clinical and medical affairs staff.
• Ensure personnel have clear goals, objectives, and milestones consistent with corporate objectives and standard operating procedures.
• Define evidence strategy, including external publications, and oversee development and execution of publications resulting from clinical studies or other associated evidence generation activities.
• Oversee office of medical affairs activities including, but not limited to, information inquiries, i.e., off-label inquiries and/or requests for more information on products, procedures and/or disease state.
• Oversee development and execution of vigilance activities such as medical safety assessment, clinical risk/benefit analysis, medical assessment of complaints, and medical advisement of Master Harms list and associated documents for relevant product categories.
• Interact with cross-functional stakeholders, (e.g., market access, marketing) to plan strategies for product life cycle and for clinical research to support these strategies.
• Support professional education activities, including oversight of conference symposia strategy and execution, as well as development of relevant content for predefined activities.
• Engage and maintain relationships with commercial leaders to ensure alignment of department activities with priorities across all interventional urology business areas.
• Provide clinical and medical affairs input into the development of the annual business plan activities.
• Manage and direct outside consultants to meet Coloplast objectives, including clinical experts, statistical experts, etc.
• Develop and maintain KOL relationships relevant to the patient populations served to ensure support for new and ongoing medical affairs and clinical research activities.
• Ensure that studies are run to current legislation, standards, and guidelines for the area and Coloplast's corporate SOPs and study specific working rules.
• Lead the IU Investigator Initiated Study Program (IISP) and oversee its associated budget.
• Assure all required post market studies and registries are established and maintained to assure continued compliance with all IU products.
• Oversee the strategic planning and execution of required clinical input into documents including, but not limited to, instructions for use (IFUs), post-market clinical plans (PMCF), clinical evaluation reports (CERs), and SSCPs, as well as FDA annual reports.
• Participate in meetings with Authorities (MHRA; DNV; FDA; TGA) for regulatory approval of the products regarding the clinical documentation, as required.
• Assure all clinical reporting as required for compliance is completed in a timely and effective manner
• Oversee the clinical evaluation of business development initiatives, including relevant due diligence of potential distribution and/or acquisitions.
• Develop business cases for clinical studies, medical affairs projects, and/or additional resources, as required.
• Actively participates as a member of the Global Innovation Leadership team.
• Work and think strategically as it relates to business needs/decisions across the Global Innovation organization beyond the direct responsibilities of the Clinical and Medical Affairs function
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
• Other job duties as assigned.

Basic Qualifications

• Bachelor's degree or equivalent required with preference of an advanced degree (e.g. PharmD, PhD, MD). Prefer a Clinical, pharmaceutical, medical, biological background.
• 10+ years' experience within clinical development (meddev, pharma, biotech), including operational activities and knowledge of ISO, FDA, GCP, etc.
• At least 5 years of people management / leadership experience including exposure to global function experience.
• Experience with budgeting on trial related activities as well as medical affairs experience.
• Experience with submission to and communication/ collaboration with Competent Authorities, with knowledge of US regulatory requirements for trial related activities.
• Experience with reporting requirements required for commercially available products, including EU MDR.
• Ability to travel up to 40%.

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, 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 $163,102 - $244,652. 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.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 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.

Visit us on Coloplast.com.

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Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

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.

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