6 Month Contract (May extend or convert to permanent)
Hybrid (2 days on site per week)
Position Summary:
The Senior Manager/Associate Director of Medical Operations will oversee the execution of Medical Affairs initiatives, ensuring alignment with strategic objectives. Reporting to the Vice President, Global Program Leader, this remote role manages timelines, budgets, and vendor relationships, supports cross-functional collaboration, and ensures compliance with regulatory requirements. Key responsibilities include financial tracking, data management, process optimization, and implementation of digital tools. The role also supports KOL engagement, congress planning, and performance tracking, providing insights to senior leadership. This position requires strong project management, operational expertise, and cross-functional coordination within a dynamic biotech environment.
Key Responsibilities:
- Support the development and implementation of the Medical Affairs Plan
- Align operational activities with overall business and medical objectives
- Oversee timelines, deliverables, and budgets for medical projects (e.g., clinical trials, publications, KOL engagement)
- Manage cross-functional initiatives with teams like R&D, Commercial, and Regulatory Affairs.
- Facilitate collaboration between Medical Affairs teams and external stakeholders such as KOLs, vendors, and contractors
- Manage vendor relationships, contracts to ensure timely, high-quality deliverables for medical activities
- Track and manage the Medical Affairs budget, ensuring efficient resource allocation.
- Oversee financial reporting, resource forecasting and accrual management to ensure accurate and timely tracking of expenses
- Prepare and submit accruals for Medical Affairs projects
- Establish processes for consistent data collection and reporting
- Ensure the collection, organization, and dissemination of medical data, such as clinical evidence and real-world data
- Work closely with data analytics teams to generate insights for stakeholders
- Ensure that Medical Affairs activities comply with regulations (e.g., FDA, EMA) and internal policies
- Oversee documentation, audit readiness, and training for medical teams
- Implement and optimize digital tools and platforms for medical activities, including CRM systems, publication trackers, and virtual engagement tools
- Act as a liaison between Medical Affairs and other departments (e.g., Legal, IT, Commercial)
- Support Key Opinion Leader (KOL) and Healthcare Professional (HCP) engagement strategies
- Facilitate advisory boards, investigator meetings, and congress events
- Develop and track Key Performance Indicators (KPIs) for Medical Affairs initiatives
- Prepare regular reports on progress and outcomes for senior leadership
- Coordinate logistics for Medical Affairs activities at scientific congresses, including venue selection and contracting, scheduling, travel arrangements, and material preparation
- Manage operational aspects of congress participation, such as symposia logistics, and booth management
- Evaluate vendor performance and negotiate contracts to align with organizational goals
Qualifications:
- Bachelor’s degree required; advanced degree (PhD, PharmD, MD, or equivalent) in life sciences preferred
- Minimum 3 years of experience in Medical Affairs, Project Management, or Operations within a biotech, pharmaceutical, or CRO setting
- Project Management: Expertise in tools like MS Project, Smartsheet, or equivalent
- Data Management: Proficiency in handling medical and clinical data
- Communication: Strong ability to present complex ideas to cross-functional teams
- Regulatory Knowledge: Familiarity with industry regulations (e.g., GCP, GPP3, Sunshine Act)
- Organizational agility and ability to prioritize
- Problem-solving and adaptability in a fast-paced environment
- Strong interpersonal and team collaboration skills
