Clinical Scientist executing and supporting clinical trials at Oruka Therapeutics. Collaborating with teams to ensure high - quality data collection and analysis for chronic skin disease treatments.
About the role
- Senior Manager overseeing clinical trials in Late-stage Oncology at Pfizer. Providing scientific oversight and collaborating with clinical operations for successful trial execution.
Responsibilities
- You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.
- Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
- Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.
- Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
- Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
- Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents;
- supports preparations for Health Authority meetings, participates as appropriate.
- Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams , governance bodies, and other internal and external stakeholders.
- In close partnership with medically qualified colleague/s , analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
- Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings , seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
Requirements
- PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO
- OR MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO
- OR BA/BS in a relevant Science discipline and minimum of 7 years Clinical Research experience in a similar role in industry/CRO
- Clinical Research experience in the phase 3/pivotal space in Oncology
- Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
- Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
- Experience working on large data sets
- Proficiency with Microsoft Office and relevant scientific software
Benefits
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- paid vacation
- holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Clinical Scientist assisting the Clinical Research Director in studies related to asthma and inflammatory diseases. Supporting clinical trial execution and document preparation at a biopharma company.
Head of CRO Channel Sales leading partnerships and direct sales for ProofPilot’s clinical trial solutions. Focused on developing high - impact partnerships within the clinical trial ecosystem.
Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
Clinical Research Study Assistant supporting neurology clinical research at WashU. Assisting in data management, document compliance, and coordinating study personnel interactions.
Seeking an Advanced Practice Provider for part - time clinical research role at SRI. Flexible hours supporting studies in Plymouth, MI with potential for growth into longer - term positions.
B(
Clinical Research Coordinator II in Boston managing research studies and patient eligibility tracking. Collaborating with a research team for patient recruitment and data processing in healthcare.
RN Clinical Research Coordinator overseeing successful implementation of oncology clinical research studies at Florida Cancer Specialists. Collaborating with Principal Investigator and team for effective study management.
Clinical Research Study Assistant responsible for participant recruitment and data collection in Radiology at the Gordon Precision Neuroimaging Lab. Ensuring adherence to protocols and quality of information.
Clinical Research Coordinator providing assistance on clinical research studies including recruiting and organizing data. Supporting patient consent and clinical tests within a hybrid work setting.