Operations Manager/Director, Scientific and Regulatory Affairs

Job Location

Flexible (Cambridge Preferred)

Job Type

Full Time

Category

Regulatory

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About the Role

Job Description:

Our Scientific Affairs team is seeking an individual to lead and build out our operational infrastructure for scientific and regulatory affairs. This is a very critical role with Accountability for our strategic approach to:  policy development, organizational excellence, departmental tracking, vendor relationships, skills and capabilities assessment, technology opportunities, and much more.  This individual will be a member of the medical and regulatory department leadership team and will oversee the day to day operation of this department.   Over time this individual will build a team underneath them to support the needs of the department and the overall organization.

This position will report to the Chief of Staff of Scientific and Regulatory Affairs and be critical to executing on our medical and scientific strategies for SKOUT, a novel artificial intelligence (AI)-aided polyp detection device, as well as other AI products in development for Crohn’s disease and ulcerative colitis.

Key Responsibilities:

  • Creating and maintaining all departmental policies, procedures and operating instructions

  • Identifying gaps in current operating model to improve overall efficiency and sophistication as the company matures

  • Tactical planning and forecasting of capabilities in order to support the Strategic priorities for Science and Regulatory Affairs

  • Management of logistics, external vendors and operational partnerships

  • Monitor external landscape to identify new technologies and opportunities to advance the way we operate our scientific organization

  • Assemble departmental reports of key activities and metrics

  • Conduct science and regulatory leadership team meeting

  • Coordination of efforts between this department and other departments of the organization

  • Elevating coordination and organization of the Science and Regulatory Affairs department

Requirements

Ideal Candidate Profile:

  • Background in project and operational management

  • Experience in the identification of need and the creation of operational documents (policies, procedures, work instructions, etc)

  • Excellent communicator and relationship builder, able to comfortably engage with stakeholders at all levels of the organization

  • Ability to actively listen and identify fundamental challenges that require addressing

  • Elevated problem solving skills

  • Ability to organize high functioning teams that are running in multiple directions

  • Ability to communicate ideas and influence without authority

  • Team mentality and ability to work in matrixed environment

  • Willing to roll up sleeves and dive in where needed

  • Desire to grow professionally and personally with potential to eventually manage direct reports

Preferred Qualifications:

  • Bachelor’s degree required; advanced degree preferred

  • 2+ years professional experience in healthcare

  • 2+ years of experience in organizational design and management

  • Project management training (Six Sigma certification preferred)

  • Ability to juggle multiple initiatives and projects

  • Capability to prioritize most important work

  • Ability to coordinate across internal and external stakeholders

  • Strong communication skills (both verbal and written)

  • Ability to guide / influence without authority

  • Confident but humble individual

  • Customer-centric thinking and activity

  • Ability to represent Iterative Scopes to external parties

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About the Company

Company Mission:

Iterative Scopes is an early-growth stage startup on a mission to revolutionize the treatment of gastrointestinal diseases with computer vision. We are backed by leading venture firms, top pharmaceutical companies as well as category defining healthcare leaders including; Obvious Ventures, Eli Lilly, Janssen Pharmaceuticals, Founders of Flatiron Health, Livongo, Path.AI, PAIGE, WHOOP!, Okta, and Recursion Pharmaceuticals.


Iterative Scopes is a venture backed company established by Jonathan Ng, MD a second time founder. The scientific advisory board includes world-class gastroenterologists and leading MIT computer vision and machine learning researchers and faculty.

Additional Info: 

The Iterative Scopes advisory board includes leading MIT computer vision and machine learning researchers/faculty and world-class Boston-area physicians and gastroenterology experts.oston-area physicians and gastroenterology experts.

Recruitment & Staffing: 

Agencies - Iterative Scopes does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Iterative Scopes or its employees is strictly prohibited unless contacted directly by Iterative Scopes' internal operations team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Iterative Scopes, and Iterative Scopes will not owe any referral or other fees with respect thereto.