Serve as primary medical and scientific expert for clinical trial protocols and Expanded Access Programs.
Monitor trials to ensure participant safety, data accuracy, and protocol compliance.
Lead protocol development, investigator training, and cross-functional collaboration.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trials, expanded access programs, and market access solutions. With 15+ years of experience across 150+ countries, they offer operational scale and a personalised culture.
Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
Oversee collection, evaluation, and reporting of safety data from clinical trials, shaping the safety governance framework.
Manage PV vendor contracts, quality/compliance for ICSR case processing, and mentor PV operations associates.
MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.
Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.
Provide strategic medical leadership for clinical safety across investigational therapies for pulmonary fibrosis.
Conduct hands-on medical review of serious adverse events and lead signal detection and benefit-risk assessments.
Oversee cross-functional safety review meetings and regulatory interactions.
The company is a clinical-stage biotechnology firm developing innovative therapies for pulmonary fibrosis and other serious respiratory diseases. It is a growing, lean organization with a focus on pharmacovigilance infrastructure and global clinical development.
Lead ongoing clinical data review to ensure quality, interpretation, and patient safety across development programs.
Develop and review study protocols, investigator brochures, and regulatory documents in partnership with cross-functional teams.
Represent Clinical Development on study teams and present clinical data and scientific information to internal and external audiences.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune disease. They cultivate an inclusive culture valuing curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Define and oversee Toxicology and Non-Clinical Pharmacology strategies for assigned projects.
Serve as the subject matter expert in Toxicology, managing preclinical safety studies and regulatory interactions.
Ensure translational aspects and safety alerts are integrated into benefit/risk assessments.
A biopharmaceutical company dedicated to developing innovative therapies for rare diseases. With over 1,900 employees in more than 30 countries, Sobi fosters a culture of inclusion and empowerment.
Provide medical oversight for clinical trials, safeguarding participant safety and ensuring protocol compliance.
Review adverse events and safety data, contributing to regulatory reporting and clinical documentation.
Collaborate with investigators and clinical teams to support study design, execution, and risk management.
This position is listed on behalf of a partner company that manages all applications and next steps. The role supports global clinical research in a remote working environment with cross-functional collaboration.
Lead medical writing for one or more clinical programs and drive content strategy for clinical and regulatory documents.
Author and manage high-quality clinical study protocols, investigator's brochures, clinical study reports, and global regulatory submissions.
Collaborate cross-functionally, mentor direct reports, and incorporate process improvements to support R&D needs.
Deciphera is a biopharmaceutical company dedicated to developing innovative medicines for people living with cancer. They value diversity and offer a competitive compensation and benefits package, fostering a culture of collaboration and professional growth.
Drive global PV Operations strategy, including planning, implementation, and management, in alignment with the Head of DSPV.
Oversee vendor oversight, case management, compliance, inspection readiness, and budget/resourcing.
Represent DSPV Operations to senior leadership, manage talent, and ensure global regulatory compliance.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, we foster a culture of empathy, owner's mindset, and urgency because patients are counting on us.
Manage end-to-end PV package preparation, quality control, and compliance tracking.
Oversee PV mailbox operations, query triage, and stakeholder communication.
Ensure inspection readiness through documentation governance and audit support.
Indegene is a technology-led healthcare solutions provider that enables healthcare organizations to be future-ready. We offer accelerated growth opportunities and a culture of entrepreneurship, innovation, collaboration, and empathy.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.
Serve as sponsor medical monitor on clinical trials, overseeing eligibility, causality assessment, and medical judgment calls.
Write medical monitoring plans, own protocol safety rules, and contribute to investigator's brochures and study reports.
Build and lead the in-house medical monitoring team as trials move in house, defining roles and hiring.
Enveda is a clinical-stage, AI-enabled biotech company discovering medicines from nature four times faster than industry standards. With over $845M in total funding and a $2B valuation, they have three oral medicines in the clinic and are recognized as one of America's Best Startup Employers and a Top 100 Most Loved Workplace.
Provide statistical leadership for oncology clinical development programs, including Phase I–III trials and regulatory submissions.
Lead development of SAPs, sample size calculations, randomization strategies, and ensure quality of statistical deliverables.
Collaborate with cross-functional teams, serve as statistical SME, and mentor junior biostatisticians.
ClinChoice is a global full-service CRO delivering clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies. With over 4,000 professionals in 20+ countries, we are committed to high-quality delivery, continuous training, and a diverse, inclusive culture.
Provide expert regulatory guidance to pharmaceutical and biotech C-suite executives, shaping critical development and portfolio decisions.
Generate new business and meet sales targets while leading complex regulatory engagements and mentoring team members.
Represent Lumanity at industry forums and contribute to practice innovation and thought leadership.
Lumanity is a global strategic partner dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. The company brings together strategy, evidence, engagement, and technology to engineer breakthrough value for biopharma clients.
Provide strategic and operational leadership across multiple clinical programs, translating development strategy into strong execution.
Oversee clinical trial planning, budgets, CRO/vendor relationships, and cross-functional collaboration to ensure quality and accountability.
Lead and develop a small Clinical Operations team while remaining hands-on in a fast-paced biotech environment.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune diseases. The company fosters an inclusive culture valuing curiosity, creativity, and shared accountability, empowering employees to drive breakthroughs.
Provide strategic medical leadership across oncology clinical programs as a trusted advisor to sponsors and teams.
Serve as Medical Monitor, overseeing patient safety, data interpretation, and safety collaborations.
Represent the organization at client meetings and conferences, mentoring medical directors and improving processes.
Precision Medicine Group is a global precision medicine-focused provider of clinical development and commercial services. The company fosters a collaborative culture centered on scientific excellence, integrity, and patient care, with a diverse international team.
Conduct toxicological risk assessments and impurity qualification for pharmaceutical and consumer health products.
Author and review toxicology modules for regulatory submissions, including CTD/eCTD dossiers.
Monitor evolving global regulations and provide scientific justification for safety assessments.
WNS is an Agentic AI-powered leader in intelligent operations and transformation, serving over 700 clients across 10 industries. With more than 66,000 employees across 13 countries, the company combines deep domain expertise with AI-powered platforms to deliver sustainable outcomes.