Manager, Clinical Scientist, Oncology

Role Summary

As a Manager in Clinical Sciences, Oncology, you will assist in the development, evaluation, planning and execution of clinical studies. Additionally, ensures scientific integrity and interpretation of study data of a clinical development program. You will work in a highly collaborative, matrixed environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development.

Reports to the Senior Director, Clinical Sciences and collaborates closely with Medical Director(s) to provide scientific expertise vital to design and deliver on clinical studies and programs.

• Contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments;
  Member of the Clinical Study Team and the Global Clinical Sub-Team
• Develops/maintains understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and limited knowledge of disease and drug landscape
• Utilizes basic scientific expertise to support execution of clinical research and development studies for early and/or late stage assets
• May assist with preparation of documents related to trials, such as medical monitoring plans, SAPs, informed consents, clinical components of the Clinical Study Reports and regulatory documents; collaborates with others for scientific and foundational guidance
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• May contribute to preparations for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority)
• Supports clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety;
  Supports identification of data trends and potential inconsistencies in data across assigned studies and raises appropriately
• Exhibits basic research and analytical knowledge to understand how study objectives and design impact data analysis; supports identification of critical risks and mitigations to study

• This Role May Be For You If:
  • Demonstrated ability to influence and share new insights with study team
  • Independently resolves most issues and complex matters, requiring sophisticated analytical skill, training and/or education. Raises highly complex problems or out-of-policy issues
  • Strong management, interpersonal and problem-solving skills
• Bachelor’s Degree required;
  Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/Pharm
  
  D/MSc)
• ≥ 5 years of pharmaceutical clinical drug development experience
• Proven knowledge of the drug development process, Good Clinical Practice, study design and clinical research methodology
• Beginner level medical writing skills
• Knowledge of the clinical development process, regulatory requirements and ICH/GCP guidelines
• Proven track record in clinical trial process improvements
• Considerable organizational awareness, including significant experience working cross-functionally

• Ability to influence and share insights with study teams
• Strong analytical, problem-solving and interpersonal skills
• Cross-functional collaboration and effective communication
• Experience with safety monitoring and data review in clinical studies