The Medical Director oversees clinical trials, data collection, and protocol implementation. Manages program development, working cross-functionally with various disciplines. Supports data analysis and contributes to the preparation of abstracts, presentations, and manuscripts.
Iovance is committed to cultivating and offering a diverse and inclusive work environment as an equal-opportunity employer.
Manage administration of the Rave URL activities: Report Administration, eLearning, User Roles and Core Configuration.
Lead development of study database, including programming of clinical database according to CRF Specifications.
Support global library by programming forms and edit checks according to data collection standards.
Jobgether is a platform that uses AI to match candidates with jobs, ensuring a quick and fair review process. They provide a supportive team culture and collaboration.
Provide clinical scientific leadership for the clinical development organization.
Lead the design and writing of clinical protocols and associated clinical documents.
Represent Immunovant externally and build successful relationships with multiple stakeholders including trial site Investigators, KOLs, and others.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Lead and execute epidemiological and real-world evidence studies.
Design and oversee study protocols and statistical analysis plans.
Manage project timelines, resources, deliverables, and risks.
Truveta is the world’s first health provider led data platform with a vision of Saving Lives with Data. Their mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. They have employees who live across the country and enjoy the flexibility of a hybrid model and working from anywhere.
Ensure departmental compliance with all applicable global regulations and Sarah Cannon SOPs.
Establish and lead the clinical operations strategy, setting departmental goals.
Promote strong cross‑functional collaboration with internal stakeholders.
McKesson delivers products to healthcare providers. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient, focused on creating an inclusive environment with strong values.
Designing, configuring, testing, and supporting eDC systems that meet the data collection needs of study protocols.
Influencing study design, data capture, and compliance with Good Clinical Practice (GCP) standards and FDA/CVM regulations.
Maintaining thorough documentation, validation reports, and data dictionaries.
Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Loyal's team includes scientists, veterinarians, engineers, operators, and creatives, and they are a well-funded startup in growth mode.
Performs cancer registry duties related to completion of abstracts for benign and malignant processes for the cancer database. Complies with the established standards of Commission on Cancer, Georgia Cancer Registry, and the Piedmont Cancer Committee. This is a remote position.
Join Piedmont to move your career in the right direction and be recognized for your contributions to exceptional patient outcomes.
Monitor and own the progress of clinical studies at investigative sites.
Coordinate all necessary activities required to set up and monitor a study.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.
Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees.
Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
Maintain study regulatory binders and files and perform internal audit and quality assurance checks on regulatory documents.
Fred Hutchinson Cancer Center is a non-profit organization focused on adult cancer treatment and research. They are based in Seattle and have a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines.
Represent Iovance Medical Affairs as a TIL cell therapy expert in both internal and external venues.
Provide high quality clinical input and review of disease strategy plans, slides, manuscripts and educational materials.
Partner with Scientific Communications to develop timely publication strategies and plan, gap analysis, and key messages.
Iovance Biotherapeutics is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, their employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
Assist with the development of the protocol and informed consent form and/or program design.
Manage vendor budgets, payments, and timelines.
Effectively track and report on internal project metrics and study progress.
Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. They are focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and operates a state-of-the art infectious disease research facility. They provide a comprehensive compensation and benefits package.
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees
Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.
Oversee clinical budgets and develop monitoring plans for effective study oversight.
Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
Drive enrollment and lead study start-up activities, adhering to timelines.
Jobgether employs AI to match candidates to job openings, ensuring fair and objective reviews. They connect top candidates with hiring companies, who then manage the final decisions and interview process.
Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
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 across the Americas, Europe, and Asia-Pacific and focus on quality, professional development, and a supportive culture.
Manage sales data and CRM, supporting bids and tenders.
Coordinate QBRs and ensure smooth communication across teams.
Evaluate processes and close gaps between departments.
Daniels Health is a global leader in healthcare safety and sustainability. They are known for their innovative reusable waste systems, industry-leading infection control, and commitment to reducing environmental impact in hospitals and healthcare facilities. Their team is purpose-driven.
Provide technical leadership for regulatory submissions.
Manage vendor relationships and internal SOPs.
Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. They embrace innovation and achieve results through cooperation and the integration of multiple viewpoints, with a focus on radical care.