Performing comprehensive chemical hazard assessments using GHS+ methodology.
Preparing detailed reports and documentation for all hazard assessments.
Providing toxicological expertise to support various projects within Enhesa.
Enhesa is the leading provider of regulatory and sustainability intelligence worldwide, helping global businesses navigate compliance and sustainability landscapes. The company serves Fortune 500 clients and offers a fast-paced, driven environment with a focus on work-life balance and accountability.
Lead scientific validation and regulatory qualification strategies to accelerate adoption of Advanced Cell Models solutions.
Drive U.S. regulatory acceptance activities including FDA ISTAND Pilot Program and DDT qualification pathways.
Build scientific collaborations with key opinion leaders and academic institutions to strengthen external scientific credibility.
Sartorius accelerates the development and production of innovative therapies for better health. As a global life science company listed on the German DAX and TecDAX, they offer a wide range of benefits and a welcoming culture.
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.
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.
Serve as TMF subject matter expert, partnering with study teams to ensure documentation is complete and inspection ready.
Lead the setup, maintenance, and quality review of electronic Trial Master Files, monitoring health and driving issue resolution.
Collaborate with clinical operations and vendors to improve TMF processes and support regulatory inspections.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. With a focus on trust, ownership, curiosity, and results, they foster a collaborative, inclusive culture.
Lead strategic development and continuous evolution of the Medical Information function to support COMP360 and pipeline assets.
Oversee development of compliant medical information response documents and collaborate cross-functionally to ensure alignment.
Establish scalable capabilities, metrics, and innovation in technology and service delivery to enhance operational excellence.
Compass Pathways plc is a biotechnology company dedicated to developing new treatment options in mental health care, with a focus on COMP360 psilocybin for treatment-resistant depression and PTSD. The company is headquartered in London, UK, with a US office in New Jersey, and leads one of the largest clinical programs in psychedelic treatments.
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.
Lead global pharmacovigilance strategy and safety governance.
Ensure compliance with FDA, EMA, ICH, and GCP standards.
Build and lead a high-performing pharmacovigilance organization.
Deciphera is a biopharmaceutical company focused on developing kinase inhibitors for cancer. The company fosters a culture of scientific excellence, accountability, and patient-focused decision making.
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.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
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.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.
Lead the full scope of Biostatistics activities for assigned clinical programs, including study design, analysis, and regulatory submissions.
Collaborate cross-functionally with Clinical, Medical, and Regulatory teams to ensure quality and timely delivery of statistical outputs.
Oversee CROs and internal teams, supervise statistical programming, and drive continuous improvement in biostatistics processes.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote organization.
Provide technical support for Abbott Toxicology assays, reagents, and instrumentation through remote and on-site customer interactions.
Lead assay and instrument implementations, validation activities, and customer training programs.
Troubleshoot technical issues, perform root cause investigations, and drive timely resolution of customer complaints.
Abbott is a global healthcare leader developing life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines. With 115,000 colleagues serving people in more than 160 countries, it is recognized as a great place to work and one of the world's most admired companies.
Independently plans and prepares regulatory documents and medical communications to support all phases of product development.
Organizes, analyzes, interprets, and presents scientific and statistical information in accordance with industry guidelines (ICH, ICMJE, GPP).
Collaborates with cross-functional internal and external teams under direction of Medical Writing management.
Veristat is a global contract research organization that accelerates life-changing therapies to patients worldwide. With over 30 years of expertise, the company has supported more than 105 approved therapies and fosters a flexible, inclusive culture with 70% remote workforce and 66% women-led teams.
Lead the scientific strategy for predictive toxicology and quantitative biology in drug discovery.
Develop advanced ML models using graph neural networks, transformers, and federated learning.
Collaborate with customers and partners to integrate AI solutions into real-world workflows.
The company is a partner of Jobgether, specializing in AI-powered solutions for life sciences and drug discovery. They are a remote-first organization with a highly skilled international team and a collaborative culture.