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.
Management of commercial API CMOs and RSM suppliers from raw material ordering oversight to manufacturing and release of API, in collaboration with various CMC functions.
Leads or supports documentation review and approval (MBRs, specs, methods), change controls and documentation for batch disposition.
Identifies and leads key process problem resolution activities and process improvement initiatives, and resolves issues.
BridgeBio is dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. It is a global biotechnology company with headquarters in San Francisco and Zug, building empowered, high-performing teams.
Leads statistical programming activities for compounds/indications or a therapeutic area.
Manages a team of statistical programmers and resource planning.
Develops SAS programs for ADaM data sets and Tables, Listings, and Figures.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
Lead programming activities for oncology clinical trials across multiple studies.
Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.
Lead site monitoring activities, while also supporting a broad range of clinical responsibilities, including process development, in-house operations, and study oversight.
Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.
Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.
CoMind is developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring.
Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities.
Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs.
Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease.
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.
Support the development and execution of the global medical communication and publication plans aligned with Medical Affairs and clinical program objectives
Author, edit, and manage a range of publication and other medical communication deliverables, including primary manuscripts and review articles
Ensure content is scientifically accurate, balanced, and aligned with source data and manage internal review, approval workflows, and version control
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease.
Medical expert with specialized therapeutic expertise.
Maintain consultative relationship with clients.
Provide medical expertise / leadership in Proposal Development Teams.
Parexel improves world health. They provide biopharmaceutical services, helping clients transform scientific discoveries into new treatments, with values like Patients First, Quality, Respect, Empowerment & Accountability.
Lead global regulatory activities for cell therapy programs as the Global Regulatory Lead. Shape regulatory strategy, lead health authority interactions, and support documentation. Collaborate with Clinical, CMC, Nonclinical, Quality, and Program Management teams.
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.