- Provide scientific input during protocol development, study design, oversight of study conduct, interpretation of study results through the final study report
- Interface with a cross-functional team including Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, Project Management, and CMC to execute and deliver milestones
- Contribute to protocol feasibility assessments, site identification, and vendor evaluation
- Collaborate with Clinical Operations to review vendor, CRO and site scope of work, study budget, and plans or manuals related to study data, IVRS, central labs, etc.
- Support preparation of abstracts, manuscripts, presentations, and materials for external meetings as related to the assigned protocol(s) and/or clinical program
- Assist in writing documents to support study conduct and regulatory submissions, including but not limited to protocols, clinical study reports, investigator brochures, informed consents forms, training documents, and lab and pharmacy manuals
- Develop internal and external training materials and training presentations, including site initiation visits
- Summarize potential safety and efficacy trends in clinical trial data, for preparation of interim and final reports of clinical trial data for study documents (including CSRs, IBs and DSURs)
- Interact with academic partners, collaborators, advisory board members, etc. as appropriate
- Support planning and conduct of study committee meetings (e.g. IDSMC), investigator meetings, and advisory boards, including contribution to presentations and minutes
- Advanced Degree in Life Sciences (i.e. DNP, APRN, PA or related medical field, PharmD, PhD) with 3 years experience; will consider Master's degree with minimum of 6 years related experience, a Bachelor's degree with 8 years of related experience, or equivalent experience
- Experience with hematology trials and familiarity with frequently used evaluations
- Knowledge of registrational clinical trial design, statistics, and data review tools
- Experience reviewing and analyzing clinical trial data to identify potential safety and efficacy trends
- Significant experience in the development of protocols, case report forms, informed consent documents, and study initiation/monitoring activities
- Ability to share scientific data effectively across functions and through presentations
- Ability to collaborate across functions and job levels within the company, as well as with external vendors and academic partners
- Attention to detail with excellent time management and organizational skills, and flexible attitude with respect to work assignments and new learning
- Self-starter and who functions well under minimal supervision
- Comfortable in a fast-paced small company environment with the ability to manage a variety of projects simultaneously and handle rapidly changing information
- Expert MS Office skills with a specific focus on word processing, formatting tables, spreadsheets, presentations, graphics, slides, and templates, in addition to Adobe Acrobat
- Knowledge of ICH Guidelines, including GCP
- Awareness of global regulatory and pharmacovigilance environments
- Minimal Travel required, anticipated 5-10% overall
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Sr. Lead Clinical Scientist, Hematology - Cranbury, United States - Rocket Pharmaceuticals
Description
OverviewWork at ROCKET PHARMA and help cure rare diseases
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases.
Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline.
We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients.This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator.
In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Position SummaryThe Sr.
Lead Clinical Scientist, Hematology works in close collaboration with cross-functional clinical, operations, regulatory and manufacturing team members, academic partners, and external vendors to enable optimal study design, conduct and analysis for Rocket's potentially transformative LVV gene therapy program in hematology.
This position reports through the Clinical Development function and provides scientific input during protocol development, oversight of study conduct, and interpretation of study results.
ResponsibilitiesA diverse workforce fosters innovation and strengthens Rocket's business.
We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
