Source Job

• Leads imaging strategy and deliverables for 15-25 global clinical trials across early- and late-stage development.
• Applies scientific and operational expertise to resolve complex imaging challenges and ensure compliance with regulatory standards.
• Partners with internal stakeholders and external vendors to drive innovation and improve efficiency in clinical imaging processes.

Merck & Co., Inc. is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The company employs thousands worldwide and maintains a culture of ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

• Provide strategic and operational leadership for Immunome's clinical trial monitoring function, including implementing contract field monitoring team and standardizing monitoring strategy across the oncology portfolio.
• Lead and develop a high-performing field monitoring function, partnering closely with Clinical Site and Trial Operations, Data Management, and Quality to ensure data quality and patient safety.
• Manage monitoring budgets, resources, and vendor oversight, ensuring compliance with ICH-GCP, FDA, EMA regulations and driving inspection readiness.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. They have a leadership team experienced in design, development, and commercialization of cutting-edge therapies including antibody-drug conjugates.

• Support operational execution of clinical studies from initial synopsis through final deliverables.
• Manage implementation, on-time execution, and conduct of clinical studies, including budget and vendor management.
• Oversee cross-functional study teams and ensure compliance with regulations and data integrity.

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy.

• Provide scientific and strategic leadership for evidence generation across a portfolio of breast cancer diagnostic products.
• Develop and execute evidence strategies supporting both in-development and commercially available assays.
• Lead external scientific collaborations and translate emerging evidence into peer-reviewed publications and clinically actionable applications.

Artera is an AI startup that develops medical artificial intelligence tests to personalize therapy for cancer patients. The company is on a mission to personalize medical decisions for patients and physicians on a global scale, fostering a collaborative and fast-paced startup culture.

• Develop and lead patient-reported outcomes strategies for clinical programs, integrating PRO measures and endpoints into study designs.
• Provide methodological expertise on PROs, including instrument selection, interpretation, and support for regulatory interactions.
• Collaborate cross-functionally with clinical, biostatistics, regulatory, and medical affairs teams to advance patient-centered evidence.

Jobgether uses an AI-powered matching process to connect top-fitting candidates with hiring companies. They emphasize efficiency and objectivity in recruitment, processing applications and sharing shortlists with employers.

• 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.

• Oversee strategic planning and execution of global clinical studies.
• Manage internal and external resources, including CROs, to ensure quality and compliance.
• Lead cross-functional teams and contribute to trial design and budgeting.

Dianthus Therapeutics is a clinical-stage biotechnology company developing novel therapies for severe autoimmune diseases. The company values a culture centered on core principles and aims to elevate patient care.

• Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
• Manages external vendors, recruitment strategies, and cross-functional team coordination.
• Maintains inspection readiness and contributes to risk management and process improvement.

AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.

• Serve as a field-based scientific expert engaging with healthcare professionals and key opinion leaders to communicate clinical data and support cell therapy development.
• Develop and execute territory-specific Medical Affairs plans aligned with therapeutic area objectives and stakeholder needs.
• Support clinical trial activities including site identification, investigator engagement, and scientific dialogue to enhance trial feasibility.

Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. The company is guided by core values of collaboration and innovation, fostering a patient-centered culture.

• Lead global regulatory strategy for assigned programs, overseeing processes and managing risks to achieve successful registration and lifecycle management.
• Collaborate cross-functionally with teams including toxicology, pharmacology, and clinical development to support clinical programs and regulatory submissions.
• Serve as point of contact with health authorities, interpret regulatory guidelines, and drive innovative approaches to regulatory sciences.

Recursion is a clinical-stage TechBio company that uses AI and technology to decode biology and accelerate drug discovery and development. The company employs hundreds across multiple global offices and values integrity, collaboration, and bold action.

• Provide strategic pharmaceutical development guidance as CMC lead to cross-functional project teams.
• Develop robust formulations and manufacturing processes to support rapid registration of QED products.
• Manage CRO relationships, drug forecasts, and regulatory submissions for clinical supply.

BridgeBio is a biotech company pioneering a 'moneyball for biotech' approach to reduce risk and accelerate development of life-changing medicines for rare diseases. They foster a culture of curiosity and experimentation, working alongside respected industry minds to reengineer the future of biopharma.

• Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
• Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
• Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.

Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.

• Prepare and manage clinical trial submissions to Competent Authorities and Ethics Committees for initial and subsequent approvals.
• Collect, review, and maintain essential documents for site activation, ensuring compliance with ICH-GCP and local regulations.
• Act as Subject Matter Expert, mentoring less-experienced staff on site start-up activities and regulatory requirements.

Precision Medicine Group is a life sciences organization that provides clinical trial and regulatory services to biopharmaceutical companies. They are expanding their presence in Latin America and foster a collaborative, fast-paced culture focused on precision medicine.

• Lead operational and lifecycle management of Regulatory CMC submissions for cell therapy programs.
• Develop and execute global regulatory CMC strategies aligning with program objectives.
• Serve as Regulatory CMC lead on cross-functional teams, providing strategic guidance.

BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. It operates as a small, mission-driven company in a fast-paced environment.

• 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.