Associate Director, Evidence Generation

Role Overview

• Execute plans with great technical depth and breadth (training & compliance, project management, medical education, grants & sponsorships)
• Define work instructions/process flows within own area/study
• Implement delivery plans and provide periodic reporting in line with overall CoE strategy (e.g. project metrics, training outcomes, grant outcomes, budgets, vendor metrics)
• Guide cross-functional and direct team members to drive compliance and address issues related to deliverables
• Actively contribute in teams and meetings
• Collaborate with other medical affairs groups and external stakeholders as required
• Train and mentor others around new technologies and scientific aspects of applied scientific research
• Oversee successful implementation of Investigator-Driven programs
• Successfully develop, implement, and manage Investigator-Driven Programs
• Execute formal review process for proposals, protocols, and amendments
• Facilitate review committee meetings and document decisions
• Drive operational timelines and key deliverables for the program or project
• Manage proposal lifecycle from submission to study closure
• Provide guidance and oversight for the successful management of all aspects of investigator-driven programs within designated program budgets and timelines
• Partner with cross-functional teams and alliance partners to manage, adjust, and revise project timelines/budgets as necessary
• Generate regular metrics and reports of program activities and present them to leadership and strategy team as needed
• Support field-based teams and MASL teams in executing project/program goals
• Work cross-functionally with internal teams which may include development, research, legal, finance, supply chain, and regulatory
• Independently manage ISTs including site coordination, document management, and drug shipment and payments
• Contribute to contract review and negotiations
• Communicate project status and issues and ensure project team goals are met
• Represent the department at cross-departmental events, as needed
• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training
• Anticipate moderately complex obstacles and client difficulties and implements solutions to achieve project goals
• Ability to resolve problems using national and international regulations, guidelines, and investigator interactions
• Participate in process improvement exercises to drive operational excellence.

Requirements

• Bachelor's or Master's or Advanced degree in a scientific discipline
• 8+ years of relevant experience in pharma/biotech industry, preferably in Oncology
• Program and/or Project management experience with leading teams, study protocols or programs preferred
• Experience managing global ISTs and/or Medical Affairs initiatives preferred
• Therapeutic knowledge in oncology (e.g. lymphoma, breast cancer, solid tumors), pharma and biologics is a plus
• Experience with budgeting and contracting
• Experience producing and analyzing metrics/reports
• High attention to detail, strong analytical and organizational skills
• Excellent ability to prioritize workload
• Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or independent non-clinical and clinical studies and articulate summary information in verbal and written form.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses