Source Job

• 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.

• Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed
• Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning

Definium Therapeutics 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, searching for patient-centric, intelligent individuals.

• Direct publication planning aligned to company goals.
• Lead cross-functional teams to implement publication plans.
• Provide scientific expertise for all publications.

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, looking for high-impact individuals.

• Develop and maintain scientifically grounded relationships with healthcare professionals, researchers, and thought leaders.
• Lead in-depth, compliant scientific conversations focused on disease understanding, research methodology, and emerging evidence.
• Collect, analyze, and communicate medical insights from the field to internal stakeholders to inform clinical development, medical strategy, and educational planning.

Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. They focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.

• Lead and develop a high-performing MSL team within a region, setting clear expectations for scientific excellence, compliance, and professional growth
• Translate medical strategy into effective field execution, ensuring consistent, high-quality scientific engagement across territories
• Ensure the timely collection, synthesis, and communication of actionable medical insights from the field to inform clinical development, medical strategy, and education planning

Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. They are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of their investigational COMP360 synthetic psilocybin treatment.

• Develop, review, and update study-related training materials and documents.
• Serve as Subject Matter Expert for clinical sites and provide guidance on protocol interpretation and eligibility requirements.
• Partner with field Clinical Research Associates (CRAs) and CTAs to resolve issues identified during site visits.

ImmunityBio is a commercial-stage biotechnology company focused on developing cell and immunotherapy products designed to strengthen the immune system to eliminate cancerous or infected cells. They are publicly traded with headquarters in Southern California, working collaboratively to transform the lives of patients.

• Develop and maintain a structured research roadmap aligned with organizational clinical priorities.
• Analyze large clinical and administrative datasets using appropriate statistical methods.
• Lead authorship and coordination of abstracts, posters, and manuscripts for CV conferences and journals.

Heartbeat Health is the leading virtual-first cardiovascular care company. They provide patients convenient, high-quality heart care, leveraging real-time data and AI-powered insights to empower providers and patients with personalized treatment plans. The company is remote-first with flexibility and autonomy at the core.

• Develop and maintain relationships with healthcare professionals within the assigned territory
• Lead scientific conversations focused on disease understanding and research methodology
• Collect and communicate medical insights from the field to internal stakeholders

Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. They are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses.

• Work with Equip’s Data Science Team and Clinical Leadership to lead the end-to-end design of internal research projects.
• Work with Equip’s Data Science Team and Clinical Leadership to meet Equip’s research mission and objectives by performing advanced statistical modeling and analysis.
• Manage the lifecycle of IRB submissions and ensure all internal projects adhere to the highest ethical and regulatory standards.

Equip is the leading virtual, evidence-based eating disorder treatment program with a mission to ensure that everyone with an eating disorder can access treatment that works. Founded in 2019, Equip has been a fully virtual company since its inception and is proud of its highly-engaged, passionate, and diverse Equisters that have created Equip’s culture.

• Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
• Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
• Maintains knowledge of the therapeutic area, disease state, and potential drug effects.

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition. As they build their core team, they're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger and passionate about making a difference to an engaged, inclusive, and positive company culture.

• 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.

• Perform discovery visits to access sites for research partnerships.
• Provide protocol and product/procedural training to clinical sites.
• Assist sites with pre-screening patients to ensure appropriateness for clinical study, as applicable.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 114,000 colleagues serve people in more than 160 countries, providing a portfolio of life-changing technologies across the spectrum of healthcare.

• Support the development and refinement of study documents under the guidance of senior clinical scientists.
• Conduct routine clinical data reviews to ensure data quality, completeness, and medical plausibility.
• Partner with clinical scientists, statisticians, and medical directors to extract and interpret scientific data for abstracts, posters, presentations, and manuscripts.

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.

• 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.

• Stand up and run the daily clinical operations for PIN/CHI delivery.
• Define the care team structure, supervision ratios, and operating cadence.
• Ensure billing-ready documentation is completed correctly every time. Partner with Compliance + RCM support to prevent leakage/denials caused by ops errors.

Carewell is focused on providing the most trusted and reputable retail source for caregiving products. They have been recognized as one of the fastest-growing companies in the US.