Jobs

Senior Clinical Scientist/Associate Director, Clinical Science

Position Overview

Reporting into the EVP of Clinical, the Senior Clinical Scientist/Associate Director, Clinical Science, will support the clinical development team by providing scientific expertise to clinical programs and collaborate with clinical operations, biometrics, data management, manufacturing, commercial and other stakeholders

Opportunity Summary

Permanent/salaried/FTE with Nuclear medicine biopharma startup; late phase oncology study underway, IPO forthcoming, unlimited career progression opportunity, work with highest level of leadership, great leadership team, dynamic, fast-paced and lean environment

Client Description

Emerging/Startup Radiopharmaceutical Oncology Biotech; less than 50 employees; northeast region

Therapeutic Information

Clinical Science/Clinical Development functional area, Radiopharmaceutical, Oncology, Prostate Cancer, Phase III Study, nuclear medicine

Education/Experience Requirements

 Advanced degree (MPH/Masters, PhD, PharmD, OR MD). 8 years relevant clinical research experience including Clinical Development

Start Date

 ASAP

Location

   Home-based anywhere with ability to work in-house in Somerset, NJ by ~2023 (relocation assistance available) 

Key Objectives

• Contribute to Health Authority Regulatory Documents (e.g. Briefing Packages, IND/CTA and NDA/NDS submission materials) and attend FDA or other Health Authority meetings related to clinical development
• Contribute to study design initiatives in collaboration with Key Opinion Leaders, Chief Medical Officer, Chief Executive Officer and Clinical Development
• Author, review, and manage core clinical study documents including study synopsis, protocols, ICFs, IBs, case report forms, DMC charters, patient guides, DSUR/IND annual reports, IRB/EC
• Support CRAs and CRO staff on study protocol related questions and serve as point of contact for managing/answering questions relating to the protocol
• Generate and/or review clinical narratives
• Monitor and mine clinical trial data for trends
• Conducts research and literature reviews
• Maintain a high level of professional expertise with clinical literature and may serve as an internal subject matter expert of a given topic                                                                                                                                                               

Key Accountabilities

• Participate in the development, review and management of clinical protocols, study manuals, ICFs, IBs, DMCs, study tools and other essential documents
• Serve as a key clinical contributor for CRF development and vendor data collection questions (e.g. lab, imaging)
• Engage with investigators, site staff, CROs, and site monitors to serve as protocol SME and to support enrollment for ongoing clinical studies.
• Monitor, review and analyze data to identify trends, inconsistencies and follow up as appropriate
• Develop slides and train study team members on various topics including but not limited to product details, therapeutic indication, literature
• Participate in the planning and execution of Investigator meetings and site initiation visits
• Support the selection of participants, development of content and execution of Advisory Board Meetings
• Ensure clinical trial data is collected according to the protocol specifications and clinical intent
• Contribute to abstract and manuscript writing
• Manage clinicaltrials.gov content and requirements
• Establish SOPs on the creation and review of documents and authorship of manuscripts   
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Education

• Pharm D, MPH/MS, PhD or MD
• 8+ years of relevant working experience in pharmaceutical/biotech
• Oncology, Radiopharmaceutical required preferred
• Clinical/Medical writing experience preferred
• Experience in principles of clinical trial methodology, statistics, data analysis and interpretation
• Understanding of GCP/ICH, FDA regulations and guidelines
• Clinical SOP knowledge

Competencies

• Inherent drive to cultivate collaboration, teamwork and professionalism
• Organized with high attention to detail, accuracy and completeness
• Excellent analytical skills
• Patient Focus: adopting patient perspective in all interactions
• Motivated to learn or advance own expertise and value
• Ability to work independently and an engaged team member in a dynamic, fast-paced and lean environment