Associate Director, Clinical Scientist

What You’ll Do:

The Associate Director, Clinical Scientist is a unique opportunity to play a key role in the research and development organization. This role allows for hands-on scientific responsibility of clinical trial execution and delivery. For this role, we are seeking a resourceful and matrixed individual who excels in operating at both the study team and leadership levels to lead in day-to-day execution, data review, and data analysis of the program in support of a Phase 3 pivotal study slated for NDA submission.

This opportunity requires a creative thinker who takes independent initiative to identify and address challenges, while working cross-functionally to drive the development and refinement of clinical and scientific processes and procedures in support of program deliverables.

This individual will assume increasing strategic and leadership responsibilities with broad external scientific communication from study start-up through reporting in support of a growing development portfolio.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

In cooperation with the Clinical Science Asset Lead and key R&D stakeholders this individual will contribute to clinical strategy with the following expectations:

• Support the Medical Directors for one or more Phase I–III clinical studies
• Lead studies across the full trial lifecycle, from start-up through database lock and reporting
• Provide scientific input to the efficacy and safety endpoint objectives of clinical trials
• Identify and provide solutions to data trends, inconsistencies, and potential issues; partnering with Data Management, Biostatistics, and Safety
• Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
• Provide clinical oversight of study execution in collaboration with cross-functional teams and ensure alignment with overall clinical strategy in partnership with the Clinical Science Lead for the program
• Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
• Develop and deliver clear, well-structured presentations to study teams
• Understand and communicate the disease and treatment landscape to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy
• Contribute to the development and standardization of templates, processes, infrastructure, and procedures to support clinical development
• Be flexible with travel and attend site related clinical development activities; form and maintain relationships with KOL’s

Required Qualifications:

• 5+ years of extensive hands-on experience supporting clinical trials in a clinical development role
• Experience working on study teams representing their technical expertise while working collaboratively with colleagues to achieve milestones and goals
• Demonstrates experience reviewing and interpreting clinical trial data listings
• Strong understanding of clinical trial conduct and cross-functional trial workflows
• Ability to work independently while navigating leadership demands by directing the broader study team in partnership with clinical operations
• Exceptional organizational, prioritization, leadership and execution skills
• Demonstrates strong ability to communicate cross-functionally
• Ability to manage multiple studies and deadlines in a fast-paced environment
• A dynamic individual who acts as the subject matter expert (SME) for the cross-functional study team and contributes to the development strategy as a member of a broader team
• Has a thorough understanding of the drug development process from IND/CTA through BLA/NDA submission
• Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization)
• Ability to understand, interpret, and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms

Education:

• RN, MS, PhD or PharmD, or equivalent with clinical research experience. Advanced degree and/or professional certification/credentials highly preferred