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Senior Director, Clinical Science & Office of Medical Affairs (Hybrid)

Location: 

Minneapolis, US

Job Family:  Research & Development
Country/Region:  United States
 

Job Function Summary:

This position is responsible for leading Clinical Science and Office of Medical Affairs within the Interventional Urology (IU) business. Develops clinical evidence and publications required to maximize the patient impact of the IU product portfolio, including regulated clinical trials as well as post-market studies. Provides medical/clinical expertise to guide the business and ensure compliance with the Coloplast quality system and regulatory requirements. Conducts clinical due diligence on new organic and inorganic growth opportunities, including M&A targets. Leads the global Clinical Science and Medical Affairs department, including team members in the US and Europe.

 

Major Areas of Accountability:

  • Develop Clinical Science and Medical Affairs strategy that enables Interventional Urology to optimize patient outcomes, comply with regulatory and quality system requirements, and meet business growth goals
  • Plan and manage studies that generate the clinical and economic evidence required to support safe and effective us of IU products
  • Ensure that studies are compliant with current regulatory requirements and adhere to Coloplast SOPs and best practices
  • Provide medical expertise to guide business decisions, either through appropriately qualified and trained staff or via consulting agreements with expert health care providers
  • Actively participate in new product development programs, to define appropriate clinical evidence requirements and plans
  • Conduct clinical due diligence on external technologies and companies, at the request of the IU business development function
  • Collaborate with the marketing team to plan clinical evidence and publication strategies that support patient treatment goals and growth objectives for IU products
  • Foster strong partnerships with physicians and other expert clinicians within the global Interventional Urology space
  • Define publication strategy and ensure timely publications resulting from clinical studies
  • Oversee and govern the Investigator Initiated Study program, ensuring compliance with legal and regulatory requirements and alignment with disease state strategy
  • Manage and direct the daily activities of the globa Clinical Science and Medical Affairs team
  • Define scope of responsibilities of the department. Ensure clinical personnel have clear goals, objectives, and milestones consistent with business objectives and standard operating procedures
  • Ensure adherence to budget and milestones
  • Responsible for hiring, training, development, and supervision of clinical staff
  • Manage and direct outside consultants to meet Coloplast clinical objectives
  • Conform with Coloplast Code of Conduct and all local Compliance Standards
  • Conform with Coloplast Q/EHS Policy
  • Other duties as assigned

 

Essential Qualifications:

  • Bachelor’s degree or equivalent required. Relevant educational background includes clinical, medical, pharmacology, biology, or biostatistics
  • 15+ years of experience in clinical operations within the med device, pharma or biotech industry
  • At least 10 years of people management / leadership experience
  • Global experience strongly preferred, via management of a global team and/or responsibility for global clinical trials, clinician relationships, and publications
  • Experience with planning and budgeting for clinical trial related activities
  • Experience with submission to and communication/collaboration with regulatory bodies, with deep knowledge of US regulatory requirements for trial-related activities
  • Ability to travel up to 40%

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 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 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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