Director, Clinical Operations

Scipher Medicine develops innovative diagnostic tests to determine drug response and targeted therapies using its proprietary personalized medicine platform based on molecular technology. Our platform allows us to interpret genomic data to gain unique insights into disease biology so patients with even the most complex diseases can achieve optimal health outcomes.

With only about 1 out of 3 patients adequately responding to anti-tumor necrosis (anti-TNF) therapies, the world’s largest selling drug class, we developed our flagship test, PrismRA™, to predict response to these drugs, thereby ensuring patients receive the most effective therapies from day one. Scipher is transforming the traditional diagnostics business model by working closely with payers to change the way medications will be prescribed, saving both insurers and patients billions wasted in ineffective prescription costs. This is a unique opportunity to join a promising venture at an early stage to tackle some of the biggest problems in healthcare.

We are proud of our passionate, high-performance, mission-driven culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2015, we are based in Waltham, MA and currently expanding across all functions within the organization. We are backed by Khosla Ventures, Northpond Ventures, Alumni Ventures and Tachyon Ventures and are well capitalized to execute our vision of launching a personalized medicine platform that transforms patients’ lives. Check us out at and follow us on LinkedIn.

The Role
The Director of Clinical Operations will be a member of Scipher’s Clinical Development organization and lead the conduct of clinical trials for Scipher’s diagnostic/therapeutic platform.

Where: Waltham, MA

What will I do?
– Provide leadership, project management, and project oversight to plan and conduct one or more high quality clinical trials concurrently in accordance with ICH GCP regulations in support of payer-driven, CLIA LDT commercialization strategies and regulatory authority submissions
– Be responsible and accountable for the conduct of our clinical trials in a timely and cost-effective manner
– Support development of clinical trial protocols and any required regulatory submissions
– Facilitate all start-up activities including but not limited to confidentiality agreements, investigational site contracts, budgets and IRB submissions
– Work within the Clinical Development Organization and collaborate with other internal Teams to identify clinical study sites to meet study goals of patient recruitment and company strategic business goals
– Qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators and field team. Support the development of presentations, handouts, and coordination of Investigator Meetings
– Develop and drive patient recruitment programs that deliver enrollment targets 
– Oversee all operational aspects of a multi-site clinical study (including identification and management of vendors, identification, selection and training of clinical trial sites, initiation of study, managing availability of clinical supplies at the sites, monitoring sites, close out of studies) to conduct study on time, on budget, in compliance, and ensuring highest quality of results
– Develop clinical trial timelines, deliverables and budgets. Proactively monitor and report trial progress and performance, timelines, and financial metrics on an ongoing basis within the Clinical Development organization, including current status of study milestones and forecast budgetary requirements based on scope of work 
– Compliance: Ensure clinical operations team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, ICH GCP guidance, and study protocol. Responsible for ensuring the trial is “audit ready” at all times. Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective sites. Notify and prepare team for regulatory agency audit and address any audit observations appropriately and in a timely manner. Perform oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported 
– Ensure integrity of sample handling and coordination with Scipher genomic lab partner

Minimum Education and Qualifications:
– Bachelor’s degree in Life Sciences, graduate degree preferred, or equivalent work experience
– 8+ years’ work experience, in In Vitro Diagnostics or Companion Diagnostics, with emphasis on clinical operations
– Expert knowledge of Good Clinical Practices and relevant ICH guidance documents 
– Strong computer skills, including Statistical programs (e.g. SAS), spreadsheet programming (e.g. Visual Basic), decision-analytical modeling, database mining and Microsoft Office applications
– Ability to work within a matrix team environment 
– Strong communication skills, both written and verbal
– Comfortable working in a fast-paced collaborative environment
– A can-do positive attitude
– Ability to laugh at yourself
– 25% travel required

To all recruitment agencies: Scipher Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, or Scipher Medicine employees. Scipher Medicine is not responsible for any fees related to unsolicited resumes.

Scipher Medicine is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.  Scipher will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.