Lead Medical Affairs workstreams including KTL engagement, congress activities, and scientific communications.
Develop and execute strategic medical plans, translating scientific evidence into actionable recommendations.
Provide scientific expertise across the product lifecycle, supporting clinical education and evidence communication.
Kaléo is a pharmaceutical company focused on developing life-saving auto-injector devices for patients. They are a lean, cross-functional organization with a passionate, purpose-driven culture and a highly collaborative, close-knit team.
Provides operational leadership for global clinical trials, overseeing the clinical operations team and vendor performance.
Ensures effective study delivery through cross-functional collaboration, proactive risk management, and strong execution oversight.
Manages CROs, vendors, and strategic partners, driving financial accountability and maintaining inspection readiness.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. With multiple global Phase 3 clinical studies, the company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Execute 12-18 MD-level engagements per quarter across defined geography, with at least 50% in top strategic community accounts.
Serve as primary MD triage for escalated area medical inquiries, ensuring 90% acknowledgment within 48 hours and 100% closed-loop documentation.
Host or present at least 12 regional educational programs per quarter and lead at least one educational initiative per cycle.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. The team is made up of highly dedicated professionals from world-class institutions, who care deeply about the work and each other.
Manage Investigator sites and conduct on-site and centralized monitoring visits to ensure subject safety and data integrity.
Collaborate with cross-functional teams and external partners to maintain quality study oversight from start-up through close-out.
Support development of study documents, maintain TMF, and ensure inspection readiness while embodying core company values.
MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The company combines cutting-edge technologies like optogenetics and spatial transcriptomics to identify novel drug targets, with a culture of integrity, collaboration, bravery, and dedication.
Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
Oversee monitoring, compliance, and data analysis while mentoring junior staff.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.
Lead and manage a team of 15-17 Study Management Associates to ensure best-in-class study execution.
Drive performance management, development, and training of direct reports in a global, remote team environment.
Support resource planning and process improvements to meet organizational goals and business continuity.
AbbVie discovers and delivers innovative medicines and solutions that solve serious health issues today and address medical challenges of tomorrow, focusing on therapeutic areas like immunology, oncology, and neuroscience. We are a global biopharmaceutical company with a large workforce and a culture that values integrity, innovation, and community service.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Oversee global clinical trial execution, including site selection, activation, enrollment, and closeout, while ensuring compliance with GCP and regulatory requirements.
Partner with CROs to drive robust trial management, data monitoring, and patient enrollment strategies, and review study-related plans and documents.
Mentor and guide clinical operations team members, track performance metrics, and ensure inspection readiness across all study phases.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving unmet medical needs through innovative clinical studies. With multiple global Phase 3 trials and offices across the US, UK, and Ireland, the company is committed to a collaborative, people-driven culture.
Supports clinical trial design, protocol development, and data interpretation to ensure high-quality data generation.
Provides medical expertise in therapeutic areas, reviews safety data, and contributes to regulatory documents.
Collaborates cross-functionally with clinical operations, regulatory affairs, and other teams to align clinical activities with development plans.
Oruka Therapeutics is developing novel biologics for chronic skin diseases. As a publicly traded biotechnology company with a startup culture, it focuses on offering patients greater freedom from conditions like plaque psoriasis.
Lead safety evaluations and benefit-risk assessments for assigned products.
Provide medical leadership for pharmacovigilance activities across development and marketed products.
Support regulatory submissions and health authority interactions, including preparing responses to RFIs.
Alphanumeric is a staffing and recruiting company that places professionals in contract roles with top organizations. This role is a 1-year contract with a major pharmaceutical company, supporting its global Safety Evaluation & Risk Management function.
Lead the design and execution of clinical studies, including investigator-initiated trials and registries.
Develop evidence-generation strategies supporting CLIA validation and reimbursement pathways.
Build relationships with key opinion leaders in head & neck oncology and represent CareDx at conferences.
CareDx, Inc. is a leading precision medicine solutions company focused on transplant patients, offering products, testing services, and digital healthcare solutions. With a focus on genomics-based information, the company aims to improve the lives of organ transplant patients worldwide.
Partner with Clinical Scientists and Clinician Services leaders to design and deliver study-specific training programs.
Develop calibration strategies, monitor clinician performance, and implement quality improvements.
Lead group training, coaching, and documentation while ensuring GCP and regulatory compliance.
Clario, part of Thermo Fisher Scientific, provides endpoint data solutions for clinical trials. Its global team has supported over 30,000 clinical trials and 70% of FDA drug approvals since 2015.
Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.
Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.
Lead and oversee global Phase 0-4 clinical trials with cross-functional teams from inception to closure.
Manage external vendors, recruitment strategies, and study systems to ensure quality, efficiency, and inspection readiness.
Collaborate with study project managers to drive timelines, budgets, and compliance with ICH/GCP and AbbVie policies.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and Allergan Aesthetics. They are a global, science-driven pharmaceutical company committed to integrity, innovation, and serving the community.
Execute 8-12 MD-level engagements per quarter within a defined geography, with at least 50% in top strategic accounts.
Maintain 3 field ride days per month alongside MSL counterparts and engage 100% of flagged accounts within 10 business days.
Deliver scientific education, support regional programs, and document exchange summaries in Salesforce.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply about the work and each other.
Lead product safety surveillance strategies and risk management for investigational products.
Oversee medical review of safety data and ensure compliance with global pharmacovigilance regulations.
Build pharmacovigilance infrastructure and manage vendor partnerships as the company grows.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. It is a growing biotechnology company with a startup culture focused on making a difference.
Provides strategic and scientific leadership for patient-centered outcomes engagements, ensuring research design and evidence packages are fit-for-purpose.
Owns client relationships, drives business development, and leads proposal development to achieve revenue and sales targets.
Oversees clinical outcome assessment projects including literature reviews, gap analyses, regulatory strategy, and dossier development.
Lumanity is a global strategic partner that brings together strategy, evidence, engagement, and technology to improve health outcomes. The company is dedicated to accelerating and optimizing access to life-changing medicines.
Serve as primary point-of-contact liaison with clients, providing outstanding customer service and participating in proposal activities and client presentations.
Oversee all aspects of clinical research trials, directing project managers and ensuring consistency across assigned portfolios.
Manage study budgets, financial health, and project plans, including risk management and quality assurance, while leading cross-functional teams.
Precision Medicine Group is a people-focused CRO that combines novel clinical trial designs, industry-leading operational and medical authorities, and advanced biomarker and data analytics solutions, with a passion for rare diseases and oncology. The company fosters a supportive and collaborative environment, promoting work-life balance and team development, with a growing team dedicated to ground-breaking cancer therapies.
Establish and maintain relationships with investigators, sites, and key opinion leaders to support trial execution.
Gather site feedback and translate it into actionable improvements for study teams.
Contribute to protocol development, site selection, and business development activities.
This role is with a partner company that focuses on clinical research and trial execution. The company operates remotely and values collaboration, inclusion, and professional autonomy.