Associate Director, Clinical Sciences, Internal Medicine

Regeneron Pharmaceuticals • Village of Tarrytown, NY

80d • $173,500 - $283,100

About The Position

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.

Requirements

• Bachelor’s Degree required.
• Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/PharmD/MSc).
• ≥ 10 years of pharmaceutical clinical drug development experience.
• 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.
• Solid medical writing skills.
• Experience in managing trials in one or more of the following therapeutic areas - cardiovascular, renal, metabolic and/or inflammatory disease.

Nice To Haves

• Strong cross-functional management and interpersonal skills.
• Strong attention to detail.
• Demonstrated ability to influence within team and across functions.
• Exhibits confidence and professional diplomacy.
• Demonstrates initiative, creativity and innovation skills.
• Identifies opportunities for process improvements.

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.
• Utilizes proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets.
• 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.
• 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.
• 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.

Benefits

• Health and wellness programs.
• Fitness centers.
• Equity awards.
• Annual bonuses.
• Paid time off for eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees