Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
Maintain expertise in GCP, EU regulations, and support business development activities.
Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.
Develop and execute US Medical Affairs strategy for evidence generation across tumor types, collaborating with internal and external stakeholders.
Provide strategic input into Global Integrated Strategic Plan and Plan of Action for ADC portfolio.
Prepare and present scientific data at internal meetings and external advisory boards.
Gilead is a biopharmaceutical company dedicated to advancing innovative medicines for life-threatening diseases like HIV, viral hepatitis, and cancer. With a global presence in over 35 countries, Gilead fosters a collaborative and inclusive culture focused on scientific excellence.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.
Develop and execute a comprehensive global training strategy for cell therapy programs across clinical and commercial stages.
Build role-specific onboarding, certification, and continuous learning pathways for Medical, Commercial, and other teams.
Ensure training content complies with FDA, EMA, and global regulatory requirements while measuring competency and launch preparedness.
The company is a clinical-stage biotechnology organization developing innovative advanced therapies. It operates in a fast-paced, collaborative environment with a focus on launch readiness and cross-functional teamwork.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.
Develop and implement global CMC regulatory strategies for biologic and combination products.
Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.
Develop and execute a global training strategy tailored to cell therapy programs across clinical and commercial stages.
Build role-specific onboarding, certification, and continuous learning pathways for Medical and Commercial field teams.
Deliver comprehensive training including disease state education, CAR T product design, clinical data, safety monitoring, and competitive landscape.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. It is a scaling biotech environment with a culture driven by core values of collaboration, clarity, innovation, and ownership.
Serve as a subject matter expert in stem cell transplantation and cell therapy, fostering deep scientific relationships with key opinion leaders and healthcare providers.
Prepare and manage a territory plan, engage with field team members to support treatment center authorization and adverse event reporting.
Gather and communicate actionable scientific insights from congresses and stakeholder interactions to inform medical strategy and evidence generation.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve outcomes for blood cancer patients undergoing stem cell transplants. It maintains a start-up culture of camaraderie, leadership by example, and a passion for science and compassion for patients.
Develop and execute product strategies aligned with business objectives and customer needs.
Own and maintain a three-year product roadmap, defining product vision, value proposition, and growth priorities.
Lead cross-functional New Product Development initiatives and guide products through the lifecycle.
ATCC is a global nonprofit that provides trusted biological materials for science and health. It is a mission-focused organization with a century of history supporting global public health.
Provide scientific, strategic, and regulatory leadership for nonclinical safety activities across Praxis’s portfolio of CNS therapies.
Own toxicology strategy for assigned programs from discovery through IND-enabling development and toward NDA/MAA.
Lead regulatory toxicology activities, including contributions to INDs, CTAs, IBs, DSURs, and responses to health authority questions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for CNS disorders. The company values trust, ownership, curiosity, and results, and is committed to diversity, equity, and inclusion.
Provide scientific and strategic leadership for evidence generation across a portfolio of breast cancer diagnostic products.
Develop and execute evidence strategies supporting both in-development and commercially available assays.
Lead external scientific collaborations and translate emerging evidence into peer-reviewed publications and clinically actionable applications.
Artera is an AI startup that develops medical artificial intelligence tests to personalize therapy for cancer patients. The company is on a mission to personalize medical decisions for patients and physicians on a global scale, fostering a collaborative and fast-paced startup culture.
Manage analytical development, QC, and stability activities at contract manufacturing sites.
Author and review CMC sections for US and ex-US regulatory filings.
Collaborate with Quality Assurance to close investigations and manage change controls.
BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.
Coordinate and track international regulatory submissions for IVD products in the EMEA region.
Manage regulatory release of products using the GTS tool and ensure compliance with IVD/medical device regulations.
Collaborate with global teams to document regulatory assessments and oversee channel partner licenses and renewals.
Agilent provides life science, diagnostic and applied market laboratories with instruments, services, consumables, applications and expertise. With 18,000 employees worldwide, the company fosters a culture of trust, respect, integrity, and inclusivity.
Partner with scientists, customers, engineers, and product managers to define and prioritize product features.
Apply broad scientific expertise to inform product design, validation, and continuous improvement.
Collaborate cross-functionally to develop scientific documentation and support regulatory compliance.
Alchemi develops advanced AI solutions for the scientific community, enabling efficient and compliant workflows across research and development. They foster a supportive, collaborative, and innovative team culture.
Serve as the Clinical Scientist for one or more Phase 2/3 studies, contributing to study design, protocol development, and oversight.
Lead data review and medical monitoring activities, identifying trends, deviations, and safety signals in collaboration with Medical Monitors.
Support regulatory submissions, cross-functional partnerships, and scientific publications to advance clinical development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a growing company with a collaborative, fast-paced environment where individual contributions have significant impact.
Manage and monitor soft tissue ablation clinical trials, including site start-up, patient recruitment, and data quality.
Prepare study documents, oversee monitoring visits, and ensure compliance with FDA and ICH-GCP regulations.
Mentor other CRAs and support both U.S.-based and future international clinical studies.
Pulse Biosciences is a novel bioelectric medicine company developing the CellFX nsPFA technology for non-thermal ablation. The company is publicly traded (Nasdaq: PLSE), fosters a culture of innovation and collaboration, and is committed to hiring top talent.
Collaborate across sophisticated evidence synthesis projects, developing deliverables like protocols and technical reports.
Manage day-to-day client communications and delegate tasks to junior researchers.
Provide mentorship and direction while independently completing complex job responsibilities.
Precision Medicine Group is a global portfolio organization that provides evidence synthesis services for health technology assessments. The company has a start-up culture in a well-funded established organization.
Provide strategic scientific leadership for clinical pharmacology across all development phases from Phase 1 through Phase 3.
Design and oversee clinical pharmacology studies, including PK/PD, exposure-response, and modeling and simulation activities.
Collaborate with cross-functional teams and support regulatory submissions to global health authorities.
Amylyx is a clinical-stage biotechnology company focused on developing therapies for diseases with high unmet needs, including ALS, Wolfram syndrome, and post-bariatric hypoglycemia. The company fosters a culture of caring with core values of audacity, curiosity, authenticity, engagement, and accountability, and has assembled an experienced team ready to tackle tough medical problems.
Serve as the CDx regulatory subject matter expert, developing global regulatory strategies for companion diagnostics and clinical trial assays.
Lead interactions with regulatory authorities and direct the preparation of global submissions, including FDA Q-Submissions, IDEs, PMAs, and EU IVDR applications.
Partner cross-functionally with pharmaceutical and diagnostic clients to align diagnostic development with therapeutic milestones and commercialization objectives.
Precision Medicine Group provides regulatory consulting services to pharmaceutical, biotechnology, and diagnostic clients, specializing in companion diagnostics and precision medicine. The company fosters a collaborative, client-focused culture with a team of regulatory experts.