Lead and manage the assigned clinical operations team, setting and executing departmental strategy.
Oversee clinical trial agreements, budgets, and the timely execution of clinical research programs from conception through final study report.
Maintain oversight of study conduct at sites, ensure adherence to protocols and GCP, and serve as company representative at external meetings.
Iovance Biotherapeutics is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. As an end-to-end cell therapy company with fully owned, centralized U.S.-based manufacturing, it operates with a fast-paced, collaborative culture focused on bringing first-in-class treatments to cancer patients.
Lead and scale the Clinical Operations function for MiraVi's ophthalmology programs.
Drive global clinical operations strategy, CRO/vendor oversight, and study execution from startup to close-out.
Partner with regulatory, CMC, quality, and finance to deliver compliant, on-time, on-budget trials.
MiraVi is an ophthalmology affiliate of Osanni focused on advancing treatments for dry age-related macular degeneration (AMD). The company is building a highly skilled, collaborative team dedicated to developing new medicines for patients.
Manage all clinical operational aspects of global trials including start-up, conduct, and close-out.
Oversee CRO and site adherence to GCP and SOPs, proactively identifying and resolving study risks.
Lead study team meetings, build investigator relationships, and support protocol development.
Vera Therapeutics is a commercial-stage biotech focused on transforming autoimmune disease treatment, starting with the kidney. Founded in 2016 in Brisbane, CA, the company values empathy, ownership, clarity, and urgency in a collaborative, fast-paced team.
Manage site and country level clinical trial operations, including vendor/CRO oversight and ensuring high-quality deliverables within timelines and budget.
Serve as the Clinical Operational Trial Lead with accountability for cross-functional delivery from protocol synopsis to Clinical Study Report and trial disclosure.
Ensure inspection readiness, data integrity, and compliance with SOPs, GCP/ICH guidelines, and FDA and state regulations.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and publicly traded on Nasdaq under DFTX, the company is relentlessly advancing a new generation of therapeutics with a mission-driven, collaborative culture.
Leads the planning, execution, and delivery of complex global clinical studies, managing timelines, budgets, and quality.
Oversees CROs and external vendors, ensuring alignment with study timelines, budgets, and contractual obligations.
Drives cross-functional collaboration and communicates study progress, risks, and decisions to stakeholders.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune diseases. The company cultivates an inclusive culture that values curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Lead, coach, and develop Site Directors and Site Managers with clear goals, KPIs, and expectations.
Monitor site operations and performance metrics to improve quality, enrollment, and protocol compliance.
Partner with site leadership on budgeting, forecasting, FTE planning, and margin management.
M3 Wake Research is a network of clinical research sites for pharma, biotech, and device companies. It has nearly 30 U.S. sites and 7,000+ completed trials, making it one of the largest independent multi-site clinical research companies.
Independently manage assigned clinical trial activities in compliance with GCP and regulations.
Oversee essential study documentation, TMF completeness, and study trackers.
Manage vendors, CTMS activities, and cross-functional coordination to ensure compliant study execution.
Cognito Therapeutics is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, including an investigational therapy for Alzheimer's disease. The company is an interdisciplinary team united by a shared purpose of protecting and progressing the human ability to think, learn and remember.
Lead clinical operations, managing a team of CTMs and CRAs on budgets, timelines, and compliance.
Ensure study delivery on time and within budget while maintaining GCP compliance and risk management.
Develop the team, set operational strategy, and collaborate across functions to support industry partners.
We are a leading provider of remote patient monitoring and a clinical research partner, founded in France in 2021. Our solutions are used by 35,000 patients across more than 200 healthcare facilities and around 20 clinical studies, and we value collaboration and celebrating success.
Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Lead and oversee complex clinical trial operations from initiation through closeout.
Serve as primary operational contact for industry-sponsored trials, ensuring quality and compliance.
Mentor clinical operations managers and drive process improvements across projects.
This is a clinical research organization managing industry-sponsored trials and providing endpoint and specialty services. It emphasizes collaboration, flexibility, and operational excellence in a remote-first environment.
Support clinical development strategies and study execution across Phase 1-3 programs.
Oversee clinical safety and data review, partnering with CROs and internal teams to ensure quality.
Contribute to protocols, regulatory documents, and study reports for respiratory disease therapies.
Celea Therapeutics is a biopharmaceutical company dedicated to advancing transformative treatments for serious respiratory diseases, with its lead program in Phase 3 clinical development. As an early-stage, mission-driven team, Celea values accountability, transparency, collaboration, innovation, and passion.
Direct and manage a team of Project Directors and Project Managers in global project delivery.
Provide leadership and oversight for clinical programs and act as primary escalation point for sponsors.
Optimize profitability, manage resources, and ensure compliance with quality standards and regulations.
Precision Medicine Group provides clinical research and project management services for global clinical trials. The company promotes a culture centered on quality, people, clients, and performance.
Lead planning, execution, and integrated governance for Future of Medicine initiatives across Clinical Conduct, Quality, Technology, and Operations.
Translate clinical, operational, quality, and program needs into scalable workflows, requirements, SOPs, and training.
Drive readiness, change planning, and sustained adoption of new program requirements and technology capabilities.
Care Access brings world-class clinical research and health services to communities facing barriers to care through hundreds of research locations, mobile clinics, and global clinicians. The company values an inclusive culture where diverse backgrounds are welcomed and people are at the heart of medical progress.
Lead operational delivery of Phase I clinical studies from start-up through close-out as the day-to-day counterpart to the CRO.
Own site relationships, drive activation readiness, and manage recruitment performance for complex dose-escalation studies.
Ensure quality and timeliness of clinical data, supplies, and vendor deliverables while maintaining ICH GCP compliance.
Numab Therapeutics is a Swiss biotech developing multi-specific antibody immunotherapies. It has a broad pipeline and completed a major J&J transaction, with Series C funding of CHF 180 million.
Own integrated program strategy for TIL cell therapy assets across early-to-late-stage clinical development.
Chair cross-functional program teams, manage timelines, and translate strategy into execution.
Partner with senior leadership to advance programs from early studies to global regulatory submissions.
Iovance Biotherapeutics is a global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors. The company operates as an end-to-end cell therapy company with fully owned, centralized U.S.-based manufacturing and is committed to a diverse and inclusive work environment.
Lead full service clinical projects in Oncology, ensuring timelines, budget, and quality.
Serve as primary client liaison and coordinate cross-functional teams across all study stages.
Manage all aspects of clinical trials, including proposal strategy, documentation, and reporting.
Precision for Medicine is a CRO enabling precision medicine through novel clinical trial designs, biomarker and data analytics, and a focus on rare diseases and oncology. We are a supportive, collaborative team that values work life balance and development.
Lead ongoing clinical data review to ensure quality, interpretation, and patient safety across development programs.
Develop and review study protocols, investigator brochures, and regulatory documents in partnership with cross-functional teams.
Represent Clinical Development on study teams and present clinical data and scientific information to internal and external audiences.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune disease. They cultivate an inclusive culture valuing curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Provide strategic leadership and operational oversight for clinical trial design, analysis, and reporting.
Build and mentor a high-performing clinical biostatistics team while driving regulatory submissions.
Partner with cross-functional teams and vendors to ensure high-quality statistical and data management support.
Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than industry standard. With over $845M in total funding and a $2B valuation, the company is recognized as a top startup employer and has three oral medicines in the clinic.
Lead the in-house Clinical Research Associate and Clinical Budget Analyst teams overseeing study start-up activities including regulatory documentation, site budgets, and vendor management.
Establish and apply start-up best practices, representing Clinical Operations on cross-functional teams and providing strategic leadership for Penumbra-sponsored clinical studies.
Recruit, hire, and directly supervise team members, allocating resources and managing project timelines to meet departmental goals.
Penumbra is a global healthcare company focused on innovative therapies. It designs, develops, and markets novel products and fosters a collaborative teamwork environment.
Serve as the primary clinical point of contact with clients, overseeing the operational portion of clinical studies per scope of work.
Develop study-related clinical documents, train CRAs and vendors, and lead internal clinical team meetings to ensure trial compliance.
Drive site feasibility, recruitment and retention strategies, and manage eTMF, budgets, and vendor oversight to ensure quality and timelines.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients, with a strong focus on Oncology and Rare Disease. The company combines new technologies, operational scale, and a collaborative environment to support the life sciences industry.