Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.
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.
Support operational execution of clinical studies from initial synopsis through final deliverables.
Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
Oversee cross-functional study teams and ensure compliance with regulations and data integrity.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.
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.
Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits to ensure adequate facilities and staff.
Identify investigators and verify qualifications, resources, and staff for conducting clinical studies.
Train investigational site staff and support regulatory submissions as applicable.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. With a collaborative international team across North America, South America, Europe, Asia, and Australia, the company values teamwork, flexibility, and work-life balance.
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 governance, harmonization, and continuous improvement of Clinical Operations processes across the organization.
Develop, simplify, and maintain Clinical Operations SOPs, work instructions, and process documentation.
Act as senior Clinical Operations SME for audits, inspections, CAPAs, and strategic initiatives.
Precision for Medicine is a global precision medicine clinical research services organization that integrates clinical operations, laboratory expertise, and data sciences. The company has a collaborative culture and supports remote work across Europe.
Lead clinical trial execution and operational delivery across internal and external stakeholders from start-up through execution.
Provide oversight of CROs, vendors, and clinical trial partners to ensure quality, compliance, timelines, and budget objectives are achieved.
Serve as the Clinical Operations leader for the team of CTMs, CRAs, and CTAs for each assigned project.
Immatics is a global leader in precision targeting of PRAME for cancer immunotherapy, with a robust clinical pipeline spanning TCR T-cell therapies and TCR bispecifics. The company fosters a collaborative and innovative culture focused on making a meaningful impact on patients.
Lead and oversee global clinical trials from inception to closure, managing cross-functional teams and vendors.
Ensure compliance with ICH/GCP and regulatory standards while driving recruitment and risk management strategies.
Manage study materials, systems (EDC, IRT, CTMS), and provide training to stakeholders.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines in immunology, oncology, neuroscience, and aesthetics. With a global presence, they emphasize integrity, innovation, and community service.
Provide regulatory strategy and guidance across the clinical development lifecycle, including submissions to Regulatory Authorities and Ethics Committees.
Coordinate and prepare regulatory documents such as CTA/IND, annual reports, amendments, orphan designations, and marketing applications.
Represent Global Regulatory Affairs at project team meetings, lead submission projects, and mentor Regulatory Affairs Specialists.
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.
Define and lead global regulatory strategy for clinical-stage radiopharmaceutical programs.
Lead key regulatory submissions including INDs, CTAs, and DMFs.
Serve as primary contact for regulatory agencies and build strong relationships with health authorities.
ARTBIO discovers and develops a new class of Alpha Radioligand Therapies (ARTs) to redefine cancer care. It is a global biotech with offices in Boston, Basel, London, and Oslo, fostering a collaborative and supportive culture.
Engage with key thought leaders and healthcare professionals to exchange clinical, scientific, and research knowledge.
Support clinical development and operations teams through site recommendations, initiation visits, and accrual support activities.
Represent Sobi at medical conferences, providing session summaries and maintaining advanced knowledge of pertinent studies and diseases.
Sobi is a specialized biopharmaceutical company dedicated to rare diseases, developing and delivering innovative therapies to improve lives of people with rare diseases. With over 1,900 employees across more than 30 countries, Sobi values diversity, inclusion, and collaboration, fostering a culture of care, ambition, urgency, ownership, and partnership.
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.
Support the development and execution of clinical regulatory strategies for assigned programs across regions.
Prepare and manage IND applications and other regulatory submissions, ensuring accuracy and timely delivery.
Provide regulatory guidance to cross-functional teams and participate in health authority interactions.
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.
Develop and execute engagement strategies for national, regional, and emerging thought leaders in rare neurological diseases.
Lead advisory boards, physician speaker programs, and congress engagement while capturing field insights to shape brand strategy.
Collaborate with Commercial, Marketing, and Medical Affairs to translate customer insights into actionable recommendations and support launch readiness.
This partner company is a pharmaceutical and biotechnology organization focused on rare neurological diseases. Their culture emphasizes cross-functional collaboration and strategic commercial leadership.
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.
Define and execute the clinical platforms roadmap and lead end-to-end product development.
Oversee platform operations, PMO governance, and delivery execution across teams and vendors.
Partner with clinical and commercial teams to position platforms as differentiated and scalable.
Fortrea is a global contract research organization supporting the development of life-saving therapies through clinical trial services. With a large, global team, Fortrea fosters a collaborative culture focused on innovation and patient-centric delivery.
Conduct on-site or remote monitoring visits to ensure site adequacy for clinical trials.
Train investigational site staff and support regulatory submissions as needed.
Mentor junior staff and perform co-monitoring visits to assess performance.
Ergomed Group provides clinical research, pharmacovigilance, and consulting services to biopharmaceutical companies, focusing on oncology and rare diseases. With a global team, they emphasize collaboration, kindness, and professional growth in a values-driven culture.
Provide medical direction and scientific leadership for the pancreatic and colorectal cancer programs.
Lead clinical study subteams, design efficient clinical trials, and monitor safety and efficacy data.
Contribute to global regulatory filings, author clinical documents, and present at scientific meetings.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer. The company's programs target the RAS/MAPK pathway, and it is driven by an audacious mission to erase cancer.
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.