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 Vice President of Clinical Development will build, lead and oversee the Clinical Development organization including Clinical Operations, Clinical Scientists, Data Management, Regulatory and Project Management while being an active member of the Scipher Leadership team. Focus on patient engagement and execute upon the strategy and operating plan of Scipher, while also leading the conception and protocol development and will oversee the execution of clinical development plans.
What will I do?
– Build and oversee the Clinical Development organization to address Scipher’s growing pipeline of diagnostic and therapeutic products.
– Organize the Clinical Development organization to efficiently and effectively execute clinical studies on time, on budget and in-line with agreed upon corporate objectives.
– Build a strong network of investigators and advisors to support clinical development of Scipher’s product pipeline.
– Build and maintain the necessary systems and infrastructure to hold and interpret patient-related data from a growing list of Scipher-sponsored clinical studies.
– Align with the internal technology and commercial teams as well as external advisors and KOLs to define PrismDx diagnostic product profiles and initiate the key clinical studies to support each product’s validation, adoption and reimbursement.
– Design and focus the development organization’s efforts on the conduct of clinical trials to gather outcomes data on PrismDx products for demonstration of clinical validity and the benefits for patients, prescribers and payers.
– Align with the internal therapeutics research and the technology teams, as well as external advisors and KOLs to establish Development Plans, and initiate the necessary clinical studies to establish proof-of-concept for Scipher’s therapeutic product candidates.
– Interact with the necessary Regulatory Authorities in the relevant regions and ensure compliance of Scipher’s clinical development activities with all necessary quality and regulatory requirement.
– Provide leadership, project management, and program oversight to plan and conduct 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
– Develop clinical trial protocol starting from near-final synopsis, develop and manage all regulatory and operational documents
– Facilitate all start-up activities including but not limited to confidentiality agreements, investigational site contracts, budgets and IRB submissions
– Partner cross-functionally with Principal Investigator and Scipher Business Team 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. Develop 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 investigators, 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 project timelines, deliverables and budgets. Proactively monitor and report trial progress and performance, timelines, and financial metrics on an ongoing basis to management team, including current status of study milestones and forecast budgetary requirements based on scope of work
Minimum Education and Qualifications:
– Medical Doctor, Board-eligible in an autoimmune disease discipline.
– Experience in developing and executing clinical trials in the biopharmaceutical industry, including protocol development and design.
– Prior experience in planning and executing clinical trials for biomarker-driven trials.
– Strong previous clinical and academic record in autoimmune diseases at a leading academic medical center.
– Strong academic record of conducting clinical research.
– Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data.
– Understanding of HIPAA and importance of privacy of patient data.
– Excellent organizational skills and attention to detail.
– 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.
IF INTERESTED IN EXPLORING THIS OPPORTUNITY PLEASE EMAIL YOUR RESUME TO CAREERS@SCIPHERMEDICINE.COM