Clinical Trials Manager

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 www.sciphermedicine.com and follow us on LinkedIn.

The Role: The Clinical Trial Manager will be responsible for engagement with a variety of external and internal partners across the life cycle of multiple studies spanning strategic and functional contributions to drive study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation.

Where: Waltham, MA.

What will I do?
-Manage study activities including strategic engagement with key collaborators; development of protocol and Informed Consent Forms; completion of study feasibility assessments; study start-up activities including contract finalization, IRB submission and approval; finalization of study manuals and processes; and, coordination and support of data integration and analysis
-Partner with established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance clinical care in complex diseases
-Partner across various internal teams, as well as external collaborators, to execute trial plan
-Experience in management of CROs, vendors and consultants
-Maintain documentation of key study decisions and plans
-Ensure timely communication of decisions and deliverables
-Identify and mitigate against study risks, escalating as necessary
-Prepare and deliver study updates to Scipher Operations Leadership team
-Mentor and manage supporting staff within the Clinical Operations organization

Minimum Education and Qualifications:
-Bachelor’s degree in health sciences or related field, Master’s degree preferred
-5 plus years directly managing clinical trials within the diagnostics, biotech or pharma industry
-Demonstrated success working within cross-functional teams
-Strong attention to detail
-Ability to work in a fast-paced, dynamic environment with a great sense of autonomy and conviction
-Experience in management of CROs, vendors and consultants
-Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
-Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and program-level budgets, site selection and clinical supplies management
-Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
-Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project, but with an ability to be adaptive and learn new programs as applicable in this role.
-Ability to work within a matrix team environment
-Strong communication skills, both written and verbal
-Ability to laugh at yourself

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.  

IF INTERESTED IN EXPLORING THIS OPPORTUNITY PLEASE EMAIL YOUR RESUME TO CAREERS@SCIPHERMEDICINE.COM