Provide leadership for overall Medical Affairs and Clinical Affairs teams.
Develop and manage the team of laboratory professionals who work in the Biosciences Medical Laboratory, to ensure timely and productive services as requested or required.
Provide subject matter expertise into design of clinical trials for medical device development and submission to the FDA and other regulatory bodies.
Lead strategic planning and execution of Medical Affairs initiatives aligned with corporate objectives.
Drive operational excellence through process improvement, change management, and performance tracking.
Partner with cross-functional stakeholders to ensure seamless integration of medical strategies.
Kardigan is a heart health company working to make cardiovascular disease preventable and curable. They're driven by patients and their families, deeply committed to improving lives and prioritizing patient needs, authentic, always learning, winning as a team, and enabling the impossible.
Manage large account relationships, drive growth, and identify partnership opportunities.
Own strategic growth plan for accounts and manage stakeholders to drive execution.
Develop and execute sales strategy for territory/market segment.
OneStudyTeam, a Reify Health company, specializes in speeding up clinical trials to improve patient outcomes. Their cloud platform, StudyTeam, is trusted by biopharmaceutical companies and used in over 6,000 research sites across 100 countries.
Managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications.
Ensuring that new products and documentation are compliant with applicable quality and regulatory requirements.
Serving as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, and post-clearance activities.
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity.
Serves as the project physician and provides medical and scientific expertise to project teams.
Ensures the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety.
Participates in the strategic planning and execution of critical development programs for clients in Oncology/Haematology.
Precision for Medicine improves the clinical research and development process for new therapeutics. Their novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step.
Lead development and execution of global regulatory strategy.
Act as a subject matter expert in regulatory affairs for product introduction.
Participate in quality system and design dossier audits.
Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.
Act as the lead clinical liaison for partner providers across multiple regions
Advocate for the clinical value of care models and address provider inquiries
Stay updated on regulatory standards to ensure compliant, high-quality care
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Their system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Responsible for LGC Clinical Diagnostics Clinical Tower sales teams with a primary focus on Clinical End User accounts.
Work internally within the commercial group and externally with strategic partners to develop and implement plans to help drive sustainable future business growth.
Develop and implement US hospital and reference lab market penetration.
LGC Clinical Diagnostics, part of the LGC Group, is a leading and trusted global IVD quality manufacturer with expertise in quality measurement tools (QMT) and reagents. They have around 450 employees across facilities in the USA, Ireland, and England.
Serve as key person between Medical Affairs and cross-functional partners.
Proactively identify inefficiencies and duplication of effort across Medical Affairs.
Maintain and continuously optimize Medical Affairs SOPs and policies.
EyePoint is a patient-centric and award-winning ophthalmology company that focuses on science and innovation to offer a lifetime of clearer vision. They specialize in sustained-release treatments for serious retinal diseases and empower curiosity and innovation in a science-based entrepreneurial culture.
Lead the development and implementation of regulatory and quality assurance strategies.
Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
Act as an internal SME (Subject Matter Expert) on regulatory requirements.
Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Define and own the enterprise laboratory informatics strategy spanning sample accessioning, order management, sample tracking, and workflow orchestration across wet labs, dry labs, and downstream data consumers.
Lead, mentor, and scale a high-performing organization of approximately 200 professionals across laboratory applications engineering, workflow platforms, data systems, validation, and operations support.
Ensure informatics platforms meet regulatory and quality requirements, including CLIA, CAP, HIPAA, FDA-regulated diagnostics (including LDTs), and applicable GxP standards.
We are a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions.
Lead and manage technical functions for all medical schemes, globally.
Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements.
Drive continuous improvement of technical workflows and quality management processes.
SGS is the world's leading testing, inspection, and certification company, recognized as the global benchmark for sustainability, quality, and integrity. With 99,600 employees across 2,600 offices and laboratories, we enable a better, safer, and more interconnected world.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Provide medical expertise and leadership in clinical development strategies aligned with company objectives.
Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
Serve as medical monitor for clinical trials and ensure adherence to ICH GCP, patient safety, and data integrity.
Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. With nearly 100 years of experience and global hubs in the U.S., France, and the U.K, they are committed to a culture of collaboration, excellence, and impact and empower every individual to be their true selves and grow alongside the company’s success.
Lead the clinical strategy and evidence generation for melanoma, non-melanoma skin cancers, and pan-tumor immunotherapy indications.
Partner closely with clinical development, medical affairs, and commercial teams to translate emerging evidence into meaningful clinical practice applications.
Collaborate with key opinion leaders (KOLs), cooperative groups, and academic investigators to validate and expand clinical use cases for ctDNA-based diagnostics in immuno-oncology.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
Set the strategic direction for federal and state quality measurement initiatives.
Provide executive oversight across the full measurement lifecycle.
Serve as a senior strategic advisor to federal and state clients.
American Institutes for Research (AIR) is a nonpartisan, not-for-profit institution that conducts behavioral and social science research and delivers technical assistance. They solve urgent challenges in the U.S. and worldwide by generating evidence and applying data-driven solutions, with headquarters in Arlington, VA.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Manage complex medical issues, coordinating care, facilitating best diagnostic and therapeutic treatment options available world-wide, and navigating the healthcare system.
Offer high level clinical management and education to clients and families in a caring, compassionate manner.
Work closely with clinical and research team, identifying latest therapies and delivering comprehensive information on medical conditions, medications, treatments, and clinical trials.
Private Health Management (PHM) supports people with serious and complex medical conditions, helping them obtain the best possible medical care. They guide individuals and families to top specialists, advanced diagnostics, and personalized care offering independent, science-backed insights to help clients make informed decisions and access the best care.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.