Senior Manager/ Associate Director, Medical Operations

Zenasbio; Waltham (MA); Remote; USD 150,000 - 200,000; Full time

Job summary

An innovative biopharmaceutical company is on the hunt for a Senior Manager/Associate Director of Medical Operations to lead Medical Affairs initiatives. This remote role involves managing timelines, budgets, and vendor relationships while ensuring compliance with regulatory requirements. You will engage in cross-functional collaboration, support KOL engagement, and implement digital tools to enhance operational efficiency. If you thrive in a fast-paced environment and possess strong project management skills, this position offers a unique opportunity to make a significant impact in the field of autoimmune therapies. Join a team dedicated to transforming patient lives through cutting-edge medical solutions.

Qualifications

• 3+ years in Medical Affairs or Project Management in biotech or pharma.
• Expertise in project management tools and data handling.

Responsibilities

• Oversee Medical Affairs initiatives, managing timelines and budgets.
• Ensure compliance with regulatory requirements and optimize processes.

Skills

Project Management

Data Management

Communication

Regulatory Knowledge

Problem-solving

Education

Bachelor's degree

Advanced degree (PhD, PharmD, MD)

Tools

MS Project

Smartsheet

Job description

Senior Manager/ Associate Director, Medical Operations

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence, and Innovation – TRUE Innovation!

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 and 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