Clinical Affairs Manager

Lincoln, NE -or- Remote with Travel 50%+
Posted 1 month ago

Contribute to advancing robotic-assisted surgery while working for a company that respects, values, and appreciates all team members!

Why you’ll love working at Virtual Incision:

  • Strong mission to expand access to robotic-assisted surgery, one of the most exciting fields in healthcare today.
  • Company-wide dedication to clinical excellence, innovation, and teamwork.
  • Friendly, open, and fun culture.
  • Opportunity to take ownership on exciting projects from day one.
  • Career development through a fast pace and an all-hands-on-deck culture.
  • Mentorship from some of the top industry experts.
  • Flexible working hours, including paid vacation and holidays.
  • Healthcare programs including medical, dental, and vision.
  • 401(k) retirement plan.
  • Company-paid life insurance.
  • Stock options.

Job summary:

As the Clinical Affairs Manager, you will be responsible for the management of Virtual Incision’s evidence generation programs and Clinical Affairs scientific activities to support the launch, commercialization, and technical knowledge transfer of the MIRA platform for current and future indications in a dynamic start-up environment.

Responsibilities:

  • Execute MIRA evidence generation programs (investigator-initiated studies, publication plans, podium presentations, non-clinical studies, etc) in cooperation with cross-functional partners for current and future indications.
  • Assist with translation and interpretation of clinical data to support evidence generation activities such as manuscripts, abstracts, marketing collateral, and/or other internal scientific communications.
  • Manage advisory boards, round tables, and establish content in collaboration with internal stakeholders.
  • Develop scientific relationships with Key Opinion Leaders (KOLs).
  • Serve as a point of contact and exchange medical & scientific unbiased information with the healthcare community.
  • Serve as a content expert and liaison to the commercial teams related to clinical data for training and collateral materials.
  • Critically interpret relevant literature and serve as a resource for clinical knowledge.
  • Support investigator-initiated clinical projects as assigned while ensuring adherence to institutional, local, federal, state, and company ethical standards.
  • Provide guidance on the design of clinical affairs projects to ensure appropriate data is collected to support launch and commercialization initiatives.
  • Provide clinical support to Regulatory Affairs in working with the regulatory bodies/agencies.
  • Performs other related duties as required.

The ideal candidate will be able to:

  • Demonstrate strong execution skills.‌ The Clinical Affairs Manager will act to implement evidence generation programs for the MIRA platform, integrating with marketing and sales, and in collaboration with and supervision by the VP of Clinical and Regulatory Affairs. They must be able to proactively make recommendations, align key stakeholders, and drive to results.
  • Thrive in ambiguity. The Clinical Affairs Manager will provide inputs and expertise to Virtual Incision’s evolving evidence generation programs for a new robotic-assisted surgery technology and must be empowered to adjust as they collect feedback and other insights. Because this is a new role at Virtual Incision, the Clinical Affairs Manager must also be adaptive and energized by the thought of being a part of a new functional area and aligning their skills with the company’s needs.
  • Influence without authority. The Clinical Affairs Manager will provide scientific expertise for internal and external projects and will influence and interface with cross-functional teams, thought leaders, academic researchers, subject-matter experts, clinicians, surgeons, and regulatory agencies that play a role in the launch and commercialization of the MIRA platform. Collaboration and excellent communication skills are a must.

Qualifications:

  • Minimum of BS in Life Sciences or Engineering (MS or Ph.D. preferred).
  • Minimum of 5 years experience in clinical research, study designs, and statistical analysis methodologies.
  • Passion for advancing scientific knowledge.
  • Knowledge of medical conferences and podium presentation strategies.
  • Excellent oral and written communication skills.
  • Superior interpersonal skills, including the ability to interact with surgeons.
  • Ability to organize and prioritize workflow to meet established timeframes.
  • Ability to work within a cross-functional team.
  • Strong attention to detail.
  • Ability to represent the company at a variety of business functions or situations in a professional and competent manner.
  • Working knowledge of Windows operating systems and Microsoft Office applications including Word, Excel, and PowerPoint.
  • Willingness to travel 50%+.

Job Features

Job CategoryClinical and Regulatory Affairs

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