Job Closed
This listing is no longer active.
Iovance is a patient-centric, collaborative organization that is driven to change the way cancer is treated.
Senior Clinical Scientist
Location
United States
Posted
82 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Scientist
Iovance Biotherapeutics, Inc.
• Supports the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.) • Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites. • Supports cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. • Provides medical monitoring support or oversight of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy data to establish the presence or absence of trends and follow up as appropriate. • Collaborates on, or lead where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses. • Supports clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning. • Maintains awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
Job Requirements
- MD, PhD, or PharmD with oncology experience required.
- Cell Therapy experience preferred.
- 6+ years of experience in a clinical research-related role. 3-5 years' experience in a Clinical science/development role preferred.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships.
- Proficient knowledge and skills to support program specific data review, trend identification, data interpretation, data cleaning.
- Experience with Spotfire and/or other data exploration tools preferred.
- Knowledge of Non-Small Cell Lung Cancer therapies preferred.
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
- Previous experience working with CROs and other vendors/suppliers preferred.
- Previous experience with Phase I-III US and Global/Ex-US clinical trials preferred.
- Data listing review experience required.
- Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature.
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.).
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel).
- Good business acumen; has working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.
- Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment.
- Good interpersonal, verbal communication and influencing skills; can influence without authority.
- Strong written communication skills.
- Good business presentation skills; is comfortable and effective when presenting to others, internally or externally.
- Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy.
- Ability to travel (~10%).
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
- Bonuses
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Biostatistician – Future Roles
Syneos HealthSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Over the past 5 years, we have worked with: 94% of all Novel FDA Approved Drugs. 95% of EMA Authorized Products. Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
• Provides support across all assigned statistical tasks during the lifecycle of the project • Prepares Statistical Analysis Plans (SAPs) • Coordinates the activities of other biostatistics and statistical programming personnel • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation • Conducts and participates in verification and quality control of project deliverables
Clinical Trial Manager I – Sponsor Dedicated
Syneos HealthSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Over the past 5 years, we have worked with: 94% of all Novel FDA Approved Drugs. 95% of EMA Authorized Products. Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits • Uses judgment and experience to evaluate overall performance of site and site staff • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented • Assesses factors that might affect subject/patient’s safety and clinical data integrity
• Deliver competent, high-quality nursing care to study patients in their homes. • Accountable for the competent and confident delivery of high-quality clinical care to patients/participants. Ensure compliance with each study’s protocol by providing thorough review and documentation at each subject study visit. • Administer investigational medications/products as needed; Perform patient assessments to determine presence of side effects; notify Principal Investigator of findings/issues. • Perform medical tests as outlined in protocol, including, but not limited to: vital signs, specimen collection, electrocardiograms; Process specimens and ship specimens per protocol. • Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment. • Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations. • Communicate effectively, promoting open and trusting relationships.
Clinical Research Coordinator
Columbia UniversityColumbia University is a private Ivy League research university located in the heart of New York City, New York. This educational institution was originally est
Manage clinical trials by coordinating patient enrollment and follow-up, maintaining regulatory and data documentation, assisting with study start-up, and collaborating with clinical teams to ensure accurate and timely data collection.
