Clinical Scientist« Go Back
Employment Status: Full-Time, On-Site
About Sapience Therapeutics
At Sapience, we think boldly about the possibilities for treating cancer. We aim to discover and develop peptide therapeutics to address oncogenic and immune dysregulation that drive cancer. To accomplish this goal, we are developing next generation peptide therapeutic candidates called SPEARS (Stabilized Peptides Engineered Against Regulation) to drug oncogenic transcription factors and regulatory pathways of disease that make cells cancerous or dampen the immune systems response against tumors. Our lead compound, ST101, is currently in the Phase 2 portion of a Phase 1/2 clinical trial and has demonstrated clinical proof-of-concept in advanced solid tumors. Our second program, ST316, received IND clearance in March 2023 and is currently enrolling patients in the Phase 1 portion of a Phase 1-2 study.
Clinical Scientist Job Overview
Primary responsibilities include medical and safety data analysis and overview to support clinical development activities. The Clinical Scientist will lead specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
- Serving as the lead clinical scientist on the clinical trial team.
- Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Medical Monitor.
- Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
- Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Ability to manage multiple competing priorities with good planning, time management and prioritization skills.
- Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
- Interact with key stakeholders across department, division, and company.
- Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
- Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
Job Duties and Responsibilities
- Safety and efficacy Data analysis to identify safety signals as well as identify different patient populations that can drive in patients’ benefit.
- Review periodic study reports for outliers, ranges, and potentially problematic data; identify and communicate root causes and suggest possible solutions, document data observations, and follow pre-established processes and procedures
- Overview of different disease and treatments landscapes among oncology field to identify and select areas for clinical development.
- Maintains availability to the sites and project team including the Sponsor to ensure that medical questions or medical aspects of project-related questions (e.g. safety, general protocol questions, subject eligibility, inclusion/exclusion criteria, screening, randomization, unblinding, dosing, termination and discontinuation, IP-specific questions, etc.) are answered or communicated for resolution.
- Develops/updates the Medical Monitoring Plan (MMP), circulating it for approval within the company and with Sponsor
- Reviews project specific plans, including the Safety Management Plan (SMP).
- Support protocol development, revisions, submission, and approval, including collaboration with study steering committee and principal investigators and communication with FDA
- Reviews medical literature in the scope of preparation of project-related documents and provides input for preparation of the respective documents.
- Trains CRAs and other team members on different topics, including medical and/or safety aspects of the project or therapeutic area/indication.
- May provide medical review of study data, as per the MMP/Medical data review plan, for clarifying and resolving data inconsistencies, query management, trend assessment, etc.
- May review requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities with preparation of responses, when requested.
- Works closely with other functional groups and departments including but not limited to Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics and QA to ensure that medical operational functions are executed effectively as per contract.
- Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations
- Advanced degree in science or engineering; PhD or MD preferred, Physician Assistant, Nurse Practitioner (NP), Advanced Registered Nurse Practitioner (ARNP) or Advanced Practice Registered Nurse (APRN), in Oncology
- Minimum of 3 years of direct oncology experience
- Research experience post-training including, but not limited to CRO, Pharma or Biotech
- Prior experience across the spectrum of Medical Monitoring activities, including Medical review of safety information
- Prior experience in development and delivery of therapeutic area/protocol-specific trainings and presentations
- Strong understanding of biostatistics
- Strong work ethic, self-motivated, team player with excellent English written and oral communication skills and strong interpersonal skills
What We Offer
- A diverse and inclusive culture where ideas are shared and your authentic self is welcome
- Exceptional, collaborative, dedicated team
- The chance to participate in work which may have a transformational impact on millions of people
- Continuous learning and dynamic challenges to help you grow and be the best version of yourself
- Comprehensive health/dental/vision insurance, 401k match, stock options, PTO
How to Apply
To apply online, please fill out the form below. If you prefer to send a letter, resume or curriculum vitae to firstname.lastname@example.org please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.
Sapience Therapeutics is an equal opportunity employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds.