Associate Director, Clinical Scientist, Internal Medicine (Cardio, Metabolic, & Renal)

About the role

The Associate Director Clinical Sciences leads 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 Associate Director reports to the 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

• May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist
• Member of the Clinical Study Team and Global Clinical SubTeam
• 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
• 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
• Applies proficient scientific expertise to propose, design, and complete 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
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Led 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
• Applies 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
• 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

Requirements

10+ years of pharmaceutical clinical drug development experience. Experience in managing clinical trials in one or more of the following therapeutic areas – cardiovascular, renal, metabolic disease. Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrates solid medical writing skills. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.