Director Medical Study Operations

Role Summary

The Director, Medical Study Operations will oversee External Sponsored Research programs including Investigator-Initiated Studies and Research Collaboration. Responsibilities include people management, establishing structure and procedures to support growth, and ensuring timely deliverables and financial management support.

Responsibilities

• Support of Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, and key deliverables, budgets, forecasting, disclosures, and compliance
• Support of Late-Stage Molecules, and launch readiness activities
• Support of Early Phases molecules, post-IND filing, ensure non-clinical and non-drug studies are reviewed in line with brand and corporate strategy, and ensuring no conflicts with ongoing development plans
• Alliance (collaboration partner) Management: Ensuring optimal alignment with both Alliance and internal collaborators for processes and strategy supporting a therapeutic area or multiple products; drive activities forward while communicating potential risks and solutions transparently
• Ensure ESR programs are led compliantly, with cross-functional reviews and inputs completed, and senior input as needed prior to implementing
• Program management: budgets, timelines, publications, risk management, compliance; oversee all aspects of program planning in support of multiple products or a therapeutic area, including life cycle management planning, budget allocation and movement, timelines and program deliverables, risk strategy/mitigation planning, and annual review of Areas of Interest in alignment with corporate strategy
• Budget tracking, planning, reporting: oversee budgeting including annual planning, projections for upcoming activities, drug-related costs, reforecasts, actuals and accrual information; budget reporting for program planning, corporate audit, sunshine act, and commercial finance
• Drug/material planning, shipping, tracking, expiry, temp excursions, quarantines: oversee planning including timing of drug and labeling campaigns, expiry events and potential impact, and ensure compliance for shipments, temp excursions, and quarantines
• Compliance: ESR processes, fair market value, safety, regulatory, training; adhere to and ensure team adherence to SOPs and guidance; create/update SOPs, practices, forms and tracking documents; ensure audit readiness
• Recruit and develop direct reports with growth-oriented goals and development plans

Qualifications

• Required: Bachelor‚Äôs degree or advanced degree or equivalent; 16+ years of progressive industry/relevant experience; mandatory Biotech/Pharmaceutical experience; 11+ years active work experience in clinical research and/or regulatory and/or field-based function in pharmaceutical/biotech company and related coursework or experience in clinical research and/or medical affairs
• Preferred: Track record of success in fast-paced, dynamic environments; self-motivated; able to work with limited supervision; ability to collaborate with clinical, pre-clinical, commercial, and external customers

Skills

• Strategic thinking and foresight for growth, improvement, and risk identification
• Effective communication and ability to influence senior management internally and externally
• Critical thinking and problem-solving for novel obstacles
• Regulatory adaptability and ability to anticipate updated regulations
• Leadership, motivation, and ensuring department-wide compliance

Education

• As specified in Qualifications

Additional Requirements

• None beyond those listed in Qualifications