Director, Clinical and Regulatory Affairs

Sherlock Biosciences is dedicated to providing global access to the simplest and most accurate diagnostic tests that empower individuals to control their own healthcare. We are creating a new generation of CRISPR and Synthetic Biology-based molecular diagnostic technology platforms that can rapidly deliver accurate and inexpensive results in any setting. We envision a world where Sherlock’s products will enable users to make more effective decisions in any environment, including hospitals, industrial settings, low-resource settings, and at-home. Successful candidates will join an exciting, collaborative, and fast-paced company that seeks to disrupt diagnostics and change the trajectory of human health.

Summary/Objective

The Director of Clinical and Regulatory Affairs is responsible for establishing and executing a bold clinical and regulatory strategy enabling FDA clearance for home and professional use of molecular diagnostic assays based on Sherlock’s CRISPR and Synthetic Biology technologies.  Scope includes establishing relationships with FDA and CROs; developing a bold regulatory strategy and companion clinical plan; leading a team to write and manage regulatory pre-subs and submissions, clinical and usability study protocols; ensuring confidentiality and integrity of clinical results; providing analysis  and documentation suitable for submission to global regulatory agencies; regular interactions with FDA and global regulatory personnel to keep submissions moving toward OTC/DTC authorization.  Success in this role is dependent on a strong background in regulatory clearance of IVD products, CLIA waiver, design validation, summative usability studies, and clinical studies for point-of-care or point-of-need in vitro diagnostic devices.  Also applicable are the ability to work with a cross-functional development team and to manage multiple parallel clinical studies in a startup environment.

 Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Establish regulatory strategy that supports authorization for OTC/DTC IVD products in the shortest reasonable timeframe
• Establish clinical strategy that supports regulatory strategy leading to 510(k) clearance, CLIA waiver, and authorization for home use of syndromic assay panels
• Preparation, submission and follow-up on FDA pre-subs
• Accountable for the definition, oversight and management of clinical and usability studies for point-of-need IVD products
• Identify, assess and manage third-party organizations as necessary to conduct clinical and usability studies
• Provide input to development teams on analytical studies and endpoints necessary as input to clinical studies and regulatory submissions 
• Provide input to development teams on translation of clinical sensitivity and specificity to analytical performance requirements
• Plan and lead data reviews to establish readiness to start clinical studies and file regulatory submissions
• Apply deep knowledge of principles and best practices in molecular diagnostic assay workflow to support product development and risk management activities
• Plan and conduct in-depth design reviews of clinical and usability data
• Regularly communicate clinical status with reports, presentations and other materials to support business activities
• Collaborate with Sherlock leadership to identify opportunities and risks and navigate technical obstacles
• Prepare, submit and manage 510(k), CLIA waiver and IVDR submissions leading to approval to sell OTC/DTC

Competencies

• Communicating with Impact
• Decision Making & Problem Solving
• Taking Initiative and Follow-up
• Planning and Organizing
• Project Management
• Building Effective Partnerships
• Team Building
• Business Acumen
• Adaptability
• Coaching and Development
• Change leadership
• Technical Skills/Professional Knowledge
• Possess Organizational Savvy
• Drive Positive Disruption
• Enable & Activate Equity
• Visionary

Supervisory Responsibilities

• This position may have supervisory responsibility

Work Environment

• Standard office and laboratory environment, including BSL 2

Physical Demands

• The physical demands require the ability to lift up to 20 lbs
• The physical demands may require standing on your feet for multiple hours in a laboratory

Travel Required

• Travel will be required for this position

Required Education and Experience

• 12+ years of experience in regulatory affairs and/or clinical validation of IVD assays with a demonstrated track record of bringing new, clinically actionable products to market
• BS in chemical or biological science, MS preferred
• Experience working within IVD regulatory requirements including CLIA waiver
• Proven track record of successful clinical demonstration of IVD molecular assays in CLIA waived environments, home use preferred
• Proven track record of successful 510(k) and CLIA waiver submissions
• Strong technical understanding of user workflow for molecular diagnostics, including associated safety risks
• Strong understanding of clinical requirements for molecular assays intended for use in the home
• Proven ability to communicate and collaborate cross-functionally – from technical to commercial and across technical disciplines
• Excellent organizational skills and ability to creatively solve ambiguous challenges
• Familiarity with CRISPR and synthetic biology and the data necessary to demonstrate their performance to global regulatory bodies is preferred
• Familiarity with challenges associated with clearance and commercialization of consumer healthcare products is preferred

Work Authorization/Security-Clearance Requirements

Must be eligible to work in the United States.

Affirmative Action/EEO Statement

Diversity, Equity, and Inclusion are not merely trendy buzz words to us; they are part of our core values.  We are committed to creating a community of well-rounded professionals from all ethnicities, nationalities, educational backgrounds, and genders.  This “melting pot” of differences is what fosters ideas and innovations. Our beliefs span beyond our walls and into the world, as reflected in outreach to various underserved domestic and global communities.

 Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job.  Duties, responsibilities, and activities may change at any time with or without notice.

Other

Sherlock requires employees to be fully vaccinated pursuant to Company policy (policy allows for potential exemptions for medical or religious reasons, consult with Human Resources for more information).

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