Clinical Development Scientist -Neuroscience

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Clinical Development Scientist (CDS) provides input into a clinical study protocol and supports a clinical study team. The CDS in the Therapeutic Area of Neuroscience provides scientific expertise necessary to design and deliver clinical studies and programs and supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution.

 

• Responsible for implementation, planning, and execution of assigned clinical trial activities. 
• Successfully leads, plans, and executes trial level activities for one or more trials 
• May co-leads clinical development team meetings in partnership with clinical development lead and collaborate with cross functional clinical development and study team members
• May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
• Position Responsibilities
• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
• Plan and lead the implementation of all study startup/conduct/close-out activities as applicable
• Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
• Site-facing activities such as training and serving as primary contact for clinical questions
• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
• Provide input to the study team for country and site feasibility assessments
• Clinical data trend identification; provide trends and escalate questions to Medical Monitor
• Develop clinical narrative plan; review clinical narratives
• Provision of information required for trial budget, CRO scope of work, etc.
• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
• Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
• Participating in Investigator meeting planning and execution and/or on-site initiation meetings.
• Engage with clinical investigators on clinical studies to enable quality clinical execution. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.

 

This opportunity can be remote in the United States or working in a hybrid environment out of West Chester, PA.

Your experience and qualifications

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
• 3+ years of experience in clinical science, clinical research, or equivalent, with preference for clinical development experience addressing neurological disorders
• Late stage clinical development experience, phase 2 and phase 3
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Familiar with scientific literature searches and weighing of quality peer reviewed data
• Ability to clearly communicate to internal and external stakeholders orally and in writing
• Key Competency Requirements
• Excellent verbal, writt