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, pharmaceutica