Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania, with a culture that emphasizes collaboration and high-quality execution.
Define and lead the Regulatory strategy for early-stage gene therapy programs (pre-IND through Phase 1/2).
Lead preparation for and participation in global health authority interactions, including FDA (CBER), EMA, and other regional agencies.
Proactively identify and communicate potential risks and define mitigation strategies.
Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Their work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
Define and lead the Industrial Engineering strategy across compounding, pharmacy, and fulfillment operations.
Architect scalable, end-to-end workflows that connect production, dispensing, packaging, and delivery.
Establish standardized operating models that can be replicated across sites
Hims & Hers is a health and wellness platform committed to helping people feel great through healthcare. They are a public company traded on the NYSE and prioritize a talent-first flexible/remote work approach.
Supports analytical development and characterization activities for late-stage biologic development leading to licensure application submission.
Takes a leading role in analytical characterization activities in support of comparability studies, heightened characterization studies, method development, control strategy development.
Supports preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed.
Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. They are a team of problem solvers dedicated to pursuing bold scientific approaches and have a collaborative spirit, breeding a culture where everyone feels inspired.
Develop and maintain end-to-end global supply chain strategy and supply network from drug substance through to finished drug product.
Oversee management of commercial contract manufacturers suppliers and identify opportunities for efficiencies and cost reduction.
Develop risk mitigation strategies which enable uninterrupted supply & business continuity.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint.
Serve as the primary Medical Monitor for assigned clinical trials.
Lead ongoing clinical data review to ensure integrity, completeness, and scientific validity.
Provide strategic guidance across functions to optimize trial design, recruitment, and execution.
Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. They are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.
Monitor updates to EP, USP, Mexico Ph, ChP, and JP.
Analyze changes in compendial requirements.
Ensure timely implementation of compendial changes.
Vertex Pharmaceuticals is focused on the discovery, development and commercialization of medicines. They strive to transform the lives of people with serious diseases.
Provide day-to-day technical support for gummy manufacturing operations.
Lead structured investigations of process deviations, yield losses, and quality issues.
Support pilot-to-production scale-up, verification/validation activities, and technical transfers.
They are the VMS Co-Op, a group of fast growing companies in the Vitamins, Minerals and Supplements (VMS) space. The VMS Co-Op includes OLLY, SmartyPants and future acquisitions to come! This position's home company is OLLY.
Provide strategic and administrative leadership for clinical research business and operational activities.
Ensure studies are conducted in accordance with regulatory requirements and sponsor expectations.
Drive operational performance, program growth, and team development across the clinical research enterprise.
Florida Cancer Specialists & Research Institute (FCS) has built a national reputation for excellence since 1984. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations, they utilize innovative clinical research, cutting-edge technologies, and advanced treatments.
Lead cross-functional project teams for 503a and 503b sterile product launches, from ideation through R&D to commercial launch.
Lead expansion and continuous improvement workstreams that support 503a and 503b sterile product development.
Build and maintain integrated project plans including key milestones, timelines, resource requirements, risks, and mitigation plans.
Hims & Hers is a health and wellness platform committed to making people feel great through better health by delivering affordable and personalized care. They are a public company traded on the NYSE under the ticker symbol “HIMS” with a talent-first flexible/remote work approach.
Review and approve Master Production Records from Contract Manufacturing Organizations.
Ensure product is manufactured, tested, stored, and distributed according to cGMPs.
Provide Quality assessments and approvals for Change Controls impacting clinical or commercial products.
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). They are working to treat all forms of HI. More information can be found at rezolutebio.com
Own the complete customer and patient journey from initial patient registration through legally compliant product sale and invoicing.
Design, launch, and lead a Kyverna-branded Navigator organization serving as the primary interface for CAR T treatment centers.
Define the enterprise patient support strategy and operating model.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and redefine what’s possible.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
Develop a short-term strategy for clinical and industry trials.
Oversee clinical trial operations, including regulatory compliance, budgeting, contracting, and performance metrics.
Manage and lead a team of clinical research coordinators and leaders across the health system
CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually and has more than 157,000 employees.
Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations.
Define and implement TMF governance, processes, and standards to ensure consistent document organization.
Serve as the TMF subject matter expert, establishing clear expectations for document structure.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Identify operational efficiencies for Apogee in partnership with key CROs and vendors and implement solutions to support delivery of Clinical Trial Operations team.
Partner with key stakeholders including Clinical Trial Operations, Vendor and Strategic Management to ensure vendor performance aligned with Apogee expectation.
Proactively identify and maintain standards to ensure consistency across all programs and studies for operationalizing global clinical trials working with assigned CRO’s.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets. They have a fast-paced company culture, founded on their C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.