Medical Director, U.S. Medical Affairs - REMOTE

I. Job Purpose And Core Tasks

The Medical Director, Medical Affairs will have broad responsibility for supporting multidisciplinary and cross-functional teams with relevant clinical information. The Medical Director will lead or be a member of multi-disciplinary teams that develop solutions for, but not limited to, Legal Affairs, Regulatory Affairs, Compliance, R&D, and/or Commercial teams. As requested, the Medical Director will engage with Key Opinion Leaders and share in the development of focus groups or clinical advisory boards. The Medical Director will lead the U.S. Medical Advisor team supporting the safe and effective use of KARL STORZ products communicating complex medical and scientific information to healthcare professionals and communicating field medical intelligence/insights to internal stakeholders. The individual will establish, foster, cultivate, and maintain bi-directional scientific communication with multiple external entities (external scientific and medical leaders, academic medical institutions, disease and patient societies etc.). The Medical Director will also lead our Communications Specialist and work closely with our Clinical Affairs team to obtain up to date evidence relevant to U.S. based projects.

The Medical Director acts as the conduit for accurate and updated clinical, scientific, and medical information between the external scientific community and the company, while ensuring that the medical team is deployed appropriately to support achievement of strategic objectives.

• Leadership position in Medical & Scientific Affairs (MSA) focused on being a being a surgical matter expert as well as and leading a team of surgical subject matter experts in a variety of medical subspecialties to support the internal and external stakeholders’ needs for medical perspectives and sound clinical decisions.
• Collaborate and support cross-functional teams, including, but not limited to, R&D, Regulatory Affairs, Commercial teams, Legal, and Compliance.
• Work strategically with U.S. MSA Leadership Team to ensure internal and external needs and priorities are being met.
• Provide medical guidance to teams working across the lifecycle of KARL STORZ products. 
• Provide clinical use scenarios for development and regulatory teams. 
• Provide integrated understanding of clinical evidence to teams as requested. 
• Prepare reports and oversee the communication of relevant information to teams based on individual need to know. 
• People Management
• Work closely with direct reports for goal setting, career development, and performance monitoring.
• Provide work direction, resolve problems, prepare schedules, and set deadlines to ensure timely completion of work.
• Assign projects and monitor progress.
• Lead medical and patient safety initiatives in the U.S., internally and externally
• Primary contact and lead as SME
• Support recall initiatives to minimize patient care disruption
• Adhere to the complaint handling process and escalate as appropriate to internal stakeholders
• Support post market surveillance initiatives to monitor safety risk
• Engage in peer-to-peer discussions to help identify and mitigate risk
• Establish product testing protocols to ensure product quality and safety
• Strategize with MSA Leadership team and lead external educational scientific program execution
• Identify unmet medical training needs for HCPs
• Develop webinars, preceptorship programs, didactic and simulation courses, etc., including KOL selection and oversight for adherence to speaker training policy
• Develop and manage an educational curriculum, calendar of events, and medical resource library to ensure timely clinical and scientific evidence for disease state awareness and product adoption.
• Lead strategy for educational content development
• Collaboration with MSA Operations Team Lead to execute logistics for program success
• Participate as a key decision maker in the Educational Grants process by reviewing and evaluating educational grant requests for alignment with KARL STORZ strategy
• Oversee searches of medical literature and communication of information from the medical literature – both as a routine and as requested, independently and in collaboration with Clinical Affairs.
• Ability to interpret and assess the quality and safety of clinical/medical research.
• Develop and execute Medical Launch Plans
• Ability to communicate clinical information to, but not limited to, colleagues from marketing, sales, regulatory and legal teams.
• Manage Medical Information Program with expertise, content development, and communication
• Excel in HCP Relationship management
• Ability to initiate and maintain meaningful relationships with clinicians to enhance the KSUS business.
• Understand KARL STORZ products, customer relationships, and the value of patient safety to both the company and healthcare
• Develop and lead Medical Advisory Boards/Focus Groups
• Represent KARL STORZ as a trusted representative, following compliance policies.
• Serve as a delegate for the U.S. Chief Medical Officer when assigned responsibilities.
• Strong work ethic with expectation of excellence from self and others. Must have high personal credibility, high intelligence, and outstanding written and verbal communication skills on scientific topics.
• Excellent organizational skills with ability to manage multiple projects, simultaneously, and engage with diverse stakeholders in a dynamic environment within tight timelines.
• Ability and willingness to work either as an equal team member on some projects or as the leader of a team on assigned projects
• Establish and manage KPIs and measurement tools to report quantitative and qualitative metrics for areas of responsibility
• Create systems and processes relevant to role and Medical Advisor team
• Key strategic partner with Global MSA to harmonize company-wide initiatives.
  
  
  

Required

II. Minimum Knowledge, Education and Skill Requirements

Minimum years of relevant work experience:

• Engaged in surgical practice for a minimum of 8+ years
• Minimum 5 years’ experience in a leadership role with direct reports.
  
  
  

Minimum education, certifications and/or credentials:

• MD or DO degree
  
  
  

Minimum hard skill requirements (including computer and application proficiency):

• Administrative experience – practice management, academic department leader, operations experience, etc.
• Demonstrate strong professional spoken and written skills in communicating with coworkers and investigators in one-on-one, small group, and large group situations
• Must have experience with Microsoft Word, Excel, PowerPoint, and SharePoint programs
  
  
  

Minimum soft skill requirements:

• Ability to lead a team to successful realization of its goals
• Ability and willingness to work either as an equal team member on some projects or as the leader of a team on other projects 
• Ability to manage multiple projects and engage with diverse stakeholders (i.e., engineering, commercial, risk management) in a dynamic environment within tight timelines 
• Ability to build relationships both internally and externally
• Comply with all policies and laws regarding industry support for research
• Understand KARL STORZ products, customer relationships, and the value of research to both the company and to healthcare
• Superior writing, presentation, and communication skills
• Protects employee, company, and investigator confidentiality
• Ability to enhance teamwork within Medical & Scientific Affairs and in relationships throughout KARL STORZ
• Ability to initiate and maintain meaningful relationships with stakeholders in all aspects of product lifecycle to enhance patient-centricity and the business of KARL STORZ
  
  
  

Preferred

Preferred years of relevant work experience:

Preferred education, certifications and/or credentials:

• Experience with medical device product development and commercialization process
• Combined clinical and research experience preferred
• Completion of General Surgery residency training program, achieving Board certification
  
  
  

Preferred hard skill requirements:

• Ability to manage complex budgets
  
  
  

Eligible Employee Benefits

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
• 3 weeks vacation, 11 holidays plus paid sick time
• Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
• 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• And much more!
  
  
  

KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.