Associate Director, Clinical Sciences, Internal Medicine

Role Summary

The Associate Director, Clinical Sciences contributes to the development, evaluation, planning and execution of Internal Medicine clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Works in a matrix environment as part of a cross-functional team (with internal and external vendor representation) and may contribute to candidate development projects through early and/or late phase development. Reports to the Sr Dir/Director, Clinical Science, Internal Medicine 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 Clinical Scientist for program, and/or as delegate of Therapeutic area 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
• 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
• Utilizes 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
• Contributes to planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators
• 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

Qualifications

• Required: bachelor‚Äôs Degree; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/PharmD/MSc)
• ‚â• 10 years of pharmaceutical clinical drug development experience, including basic knowledge of Metabolic disease and/or inflammatory disease areas
• Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology and strong medical writing skills
• Strong team-player with experience in all aspects of conducting global clinical trials and execution of clinical programs
• Experience managing trials in cardiovascular, renal, metabolic and/or inflammatory disease areas

Skills

• Cross-functional management and interpersonal skills
• Attention to detail

Education

• Bachelor‚Äôs degree required; Advanced degree (PhD/PharmD/MSc) preferred

Additional Requirements

• Experience in one or more therapeutic areas - cardiovascular, renal, metabolic and/or inflammatory disease - required