Associate Director, Clinical Scientist, Oncology

Role Summary

Associate Director, Clinical Scientist, Oncology. Leads development, evaluation, planning and execution of oncology clinical studies and ensures scientific integrity and interpretation of study data within a clinical development program. Works in a matrix cross‑functional environment and may contribute to candidate development projects through early and/or late phase development. Reports to the Director, Clinical Sciences and collaborates closely with Medical Directors to provide scientific expertise necessary to design and deliver on clinical studies and programs.

• May function as lead Clinical Scientist for the program, and/or as delegate of Therapeutic area Lead Clinical Scientist
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments;
  Member of the Clinical Study Team and Global Clinical Sub Team
• Maintains proficient 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 drug landscape as well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature
• Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
• Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support
• Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority);
  Presents data and information to external investigators (SIV) and internal stakeholders
• Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
• Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis;
  Identifies risks and designs mitigation strategies
• Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs;
  Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program

• This role may be for you if you can lead activities within a matrix environment; exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; demonstrated ability to influence within the team and may influence across functions
• Demonstrates initiative, creativity and innovation skills; directly or indirectly contributes to the development of innovations; identifies opportunities for process improvements
• Resolves novel problems requiring creative application of advanced skill, training, and education
• May serve as a peer coach learning how to mentor and provides guidance to junior members of department and cross-functional team members as appropriate
• Required:
  
  Bachelor's Degree in life science/healthcare or equivalent; ≥ 10 years of pharmaceutical clinical drug development experience; strong cross-functional management, interpersonal and problem-solving skills; proficient knowledge of the clinical development process, regulatory requirements and ICH/GCP guidelines
• Preferred:
  Advanced degree (PhD/MD/Pharm
  
  D/MSc) or equivalent

• Bachelor’s Degree in life science/healthcare; advanced degree (PhD/MD/Pharm
  
  D/MSc) preferred

• Leadership in a matrix environment with cross‑functional collaboration
• Scientific expertise in clinical research and development; ability to design and propose strategy grounded in literature
• Experience in medical monitoring plans, SAPs, informed consent procedures, and clinical study reports
• Data review and safety monitoring with a focus on patient safety
• Analytical skills to understand how objectives impact data analysis and identify risks with mitigation strategies
• Regulatory knowledge of FDA/EMEA/ICH/GCP guidelines and applicable SOPs
• Effective communication and presentations to external investigators and internal stakeholders