Lead and oversee end-to-end clinical trial operations from study start-up through close-out.
Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.
Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.
Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision-making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single-asset companies to improve productivity.
Assist in design, author and/or review clinical study synopses, protocols, study reports and other study-related documents.
Act as a medical monitor for assigned study and discuss study design with investigators and key opinion leaders.
Track emerging efficacy and safety profile of drugs in clinical trials; inform Clinical Development team of changes in the efficacy/safety profiles.
Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer patients. The company aims to improve cancer treatment by targeting cellular drivers of tumor growth and is publicly traded.
Bring medical and scientific expertise to the design, execution, and interpretation of clinical studies ensuring patient safety and scientific integrity
Author and oversee key clinical documents including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions
Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding our presence and global footprint, searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team.
Lead the planning, execution, and management of clinical trials.
Ensure compliance with FDA, ICH-GCP, and other regulatory standards.
Supervise and mentor Clinical Research Associates (CRAs) and study coordinators.
Jobgether leverages AI to match candidates with fitting roles, ensuring quick and fair application reviews. They connect top candidates directly with hiring companies, who then manage the final decision-making process.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Design and execution of ongoing and new clinical studies, contributing to the clinical development plan.
Lead and/or serve as the clinical science representative on clinical studies to deliver high quality data for registration.
Partner with stakeholders to deliver clinical programs for registration and launch.
Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019, they are continuously expanding their presence and global footprint and searching for high-impact individuals.
Provide statistical strategy and oversight for multiple clinical studies.
Design studies, author and review protocols and Statistical Analysis Plans.
Support regulatory submissions, including health authority interactions.
Deciphera is committed to equal employment opportunity and values diversity. The company believes in providing a competitive compensation and benefits package to all employees and has an outstanding culture and opportunities for personal and professional growth.
Serve as a subject-matter expert on global clinical and regulatory writing projects
Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
Drive development of key clinical documents that align with overall program and submission strategy
Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.
Lead statistical programming efforts for clinical studies.
Oversee and coordinate activities with Contract Research Organizations (CROs).
Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner.
Kailera is developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, they are working together to advance novel therapies for obesity and related conditions.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Serves as the project physician and provides medical and scientific expertise to project teams.
Ensures the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety.
Participates in the strategic planning and execution of critical development programs for clients in Oncology/Haematology.
Precision for Medicine improves the clinical research and development process for new therapeutics. Their novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step.
Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management.
Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
Identify risks and propose solutions to facilitate clinical studies.
Nuvalent is working to create selective medicines designed to address the needs of patients with cancer. They are an exciting early-stage company with experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Lead programming activities for oncology clinical trials across multiple studies.
Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries and consider their employees their most valuable asset.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.
Author administrative and CMC regulatory documents in collaboration with SMEs.
Manage full CMC submissions, ensuring compliance with requirements.
Jobgether is a company that uses an AI-powered matching process assisting partner companies with their recruitment needs. They aim to ensure applications are reviewed quickly, objectively, and fairly.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Global Regulatory Lead for a cutting edge RPT programs
Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
Lead the preparation and submission of regulatory filings
RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.
Ownership of scientific and operational statistical work for clinical trials.
Develop study Statistical Analysis Plans and study documents.
Provide statistical expertise in support of interactions with regulatory agencies.
Tarsus is dedicated to attracting and retaining top talent. The company offers comprehensive benefits, bonus, and stock equity to promote work-life balance.