Lead global Pharmacovigilance Operations, Quality & Compliance strategy to ensure scalable, inspection-ready systems.
Oversee case processing, vendor governance, PSMF, quality systems, audits, and regulatory inspections.
Build and mentor a global team, collaborating cross-functionally to support portfolio growth and commercialization.
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.
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.
Manage execution of study-level activities, including creating trial documents and overseeing vendor delivery and budgets.
Coordinate country and regional trial management, aligning feasibility strategies and mitigating local risks.
Support program-level compound training and mentor new team members in Trial Management.
Johnson & Johnson is a global healthcare innovator focused on preventing, treating, and curing complex diseases through Innovative Medicine and MedTech. With a large workforce, they emphasize an inclusive work environment guided by their Credo, respecting diversity and dignity.
Provide senior statistical leadership across clinical development projects in ophthalmology.
Lead statistical analysis plans, study design, and regulatory submissions.
Mentor biostatistics professionals and collaborate with cross-functional teams.
The partner company specializes in clinical research and statistical leadership for ophthalmology programs. It offers a fully remote European work environment with a collaborative culture and opportunities for career development.
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 clinical development strategy and oversee programs from IND through Phase III, ensuring scientific and regulatory excellence.
Manage global vendor, investigator, and KOL relationships to drive successful trial execution and pipeline progression.
Build and mentor a high-performing team while ensuring budget, timeline, and quality targets are met.
ProKidney is a clinical-stage biopharmaceutical company focused on developing innovative therapies for kidney disease. The company fosters a culture of scientific rigor, collaboration, and continuous improvement, with a commitment to quality and compliance.
Oversee strategic and operational execution of clinical trials, leading cross-functional teams and managing vendor selection.
Direct clinical trial budgets, risk mitigation, and provide technical input into key clinical documents.
Mentor staff and foster strong team relationships in a dynamic organization.
Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. The company was launched based on assets licensed from Paragon Therapeutics and has a growing pipeline.
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.