Scipher Medicine is launching a personalized medicine platform for patients with autoimmune diseases that interpret an individual’s own molecular data to ensure care is tailored to improve the prospect of reaching remission. Most patients diagnosed with autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis face a long and difficult journey of trial error treatment of switching between different drugs with severe side effects without any clinical benefit as most approved drugs only benefit few patients. Beyond being exposed on unnecessary side effects the disease can progress to an irreversible stage while escalating pain is managed by an increased use of opioids. Scipher’s platform allows clinicians to select most optimal treatment pathway for each individual patient. The molecular data from our growing patient population using Scipher’s platform is further analyzed to develop novel therapies for patients who do not respond to current standard of care.
Scipher is driven by data, passionate about improving healthcare, determined to push science, and convinced the fastest way forward is through collaboration. This is a unique opportunity to join a promising and exciting new venture tackling one of the largest problems in health care today.
Scipher is backed by Khosla Ventures, Northpond Ventures, Alumni Ventures and Tachyon Ventures and has raised $30 million to date.
Scipher Medicine is seeking a talented and highly motivated Senior Clinical Trials Manager to lead trial management in support of Scipher Medicine’s multiple development arms.
The Senior 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. This position requires both the knowledge and experience to work within 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.
Primary Responsibilities and Essential Duties
·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.
· Work across various internal teams, as well as external collaborators, to execute trial plan.
· 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 Ops leadership.
· Mentor and manage supporting staff within the Clinical Operations organization.
· A minimum of 5 years directly managing clinical trials within the Diagnostics, Biotech or Pharma industry.
· Demonstrated success working within cross-functional teams.
· Excellent verbal and written communication skills.
· Strong attention to detail.
· Willingness and 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.
· Proficient written and verbal communication skills.
· 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.
· Position may require some travel.
· Bachelor’s degree in health sciences or related field, Advanced Degree preferred.
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.
IF INTERESTED IN EXPLORING THIS OPPORTUNITY PLEASE EMAIL YOUR RESUME TO CAREERS@SCIPHERMEDICINE.COM