Commercial Clinical Strategy Manager
Elephas
Elephas is seeking a Commercial Clinical Strategy Manager to lead and oversee the generation of our clinical data workflows ensuring alignment with organizational goals. This role will monitor program performance working closely with the clinical team and commercial teams to ensure clinical trials and registries are designed to yield data to support company milestones, timelines, budgets, and resource allocations. They will lead the strategic development and execution of clinical data workflows across our diagnostic platform including how clinical data is captured, structured, and delivered—ensuring it drives product innovation, and regulatory readiness.
Key Responsibilities
Program Oversight:
- Develop and manage strategy for clinical programs (trials and registries) for clinical data collection, organization, lifecycle of each, and reporting
- Ensure alignment of data collection with organizational goals to ensure consistency, ease of use, ROI, and clinical relevance to support our diagnostic platform
- Develop clinical data roadmap to outline clearly for clinical teams required deliverables, metrics, and goals
- Offer clinical insights into research processes and actively monitor the evolving immune checkpoint inhibitor (ICI) landscape to assess its influence on treatment protocols, ensuring timely updates to clinical programs and data capture strategies.
Data Quality & Market Readiness
- Strategic driver of data collection – working closely with CMO to identify future need to satisfy the partners/customers based on the most likely future prescribing behaviors
- Establish and oversee processes for data validation, normalization, and quality control
- Ensure clinical data outputs are accurate, interpretable, and formatted for use in clinical settings, including pathology labs, oncology clinics, and hospital systems
- Collaborate with clinical and software teams to build tools that support clean data capture and automated reporting
Clinical Reporting & Usability
- Develop reporting frameworks that convert complex biological data into clear, clinically actionable insights.
- Collaborate with oncologists, pathologists, and other clinical stakeholders to ensure reports are relevant and user-friendly.
- Continuously improve report formats based on feedback from clinical trials and pilot program deployments.
Cross-Functional Leadership
- Lead cross-functional collaboration across clinical operations, R&D, regulatory, and engineering to ensure data workflows effectively support product development and clinical impact.
- Championing the clinical data strategy internally, driving cross-departmental alignment and integration to maximize clinical utility
Compliance & Documentation
- Ensure data systems and reporting tools comply with relevant standards (e.g., HIPAA, CLIA, CAP).
- Support documentation for regulatory submissions, clinical protocols, and quality audits.
Required Skills and Qualifications
- Advanced degree in life sciences, biomedical engineering, or related field
- 5+ years of experience in project management (PMP certification a plus), clinical programs or trial management, or data strategy within diagnostics, biotech, or pharma
- Proven leadership in managing clinical data systems and cross-functional product teams
- Deep understanding of clinical data types (e.g., histopathology, genomics, imaging) and their role in translational research
- Ability to analyze clinical data and generate actionable insights
- Experience in EDC systems and clinical trial software
- Exceptional communication, strategic thinking, and stakeholder management skills
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.