Manager, Internal Medicine, Clinical Scientist (Immune/Inflammatory)

About the role

The Manager Clinical Scientist assists in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Manager works in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Manager reports to the Associate Director/Director Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.

Responsibilities

• Member of the Clinical Study Team and the Global Clinical SubTeam; regularly attends and actively participates in study team meetings
• May contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; participates in collaborative activities with other departments
• Develops/maintains basic 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
• Applies basic scientific expertise to support execution of clinical research and development studies for early and/or late stage assets
• Makes contributions to preparation of documents related to trials, such as medical monitoring plans, SAPs, informed consents, clinical components of the Clinical Study Reports and regulatory documents; collaborate 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
• Contributes 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 concerns
• 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

Requirements

• Demonstrated basic knowledge of the drug development process, Good Clinical Practice, study design and clinical research methodology
• Beginner level medical writing skills
• Some ability to influence within study team
• Independently resolves most issues and complex matters, requiring advanced analytical skill, training and/or education
• Raises highly complex problems or out-of-policy issues
• Strong management, interpersonal and problem-solving skills
• Proven track record in clinical trial process improvements
• Considerable organizational awareness, including significant experience working cross-functionally

Qualifications

• BS/MS/PhD/PharmD in a related area
• ≥ 6 years of pharmaceutical clinical drug development experience
• Experience in immune/inflammatory related clinical trials preferred
• Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines