Director, Medical Operations
Intellia Therapeutics, Inc.
4 hours ago
Remote friendly (Cambridge, MA)
United States
Operations
How You Will Achieve More
The Director of Medical Operations will lead the operational strategy and execution of Medical Affairs initiatives, ensuring alignment with organizational goals. This role optimizes processes, manages cross-functional projects, and supports the Medical Affairs team in delivering high-impact medical strategies, with strong leadership and operational expertise and knowledge of biotech compliance and regulatory landscapes.
Responsibilities
Strategic & Operational Leadership
- Develop and implement operational strategies to streamline Medical Affairs activities, including medical communications, publications, medical information, and congress planning.
- Oversee the creation and maintenance of SOPs to ensure compliance with FDA, EMA, ICH-GCP, and company policies.
- Drive process improvements to enhance efficiency and scalability.
Cross-Functional Collaboration
- Partner with Clinical Development, Regulatory Affairs, Commercial, and R&D to align medical operations with corporate objectives.
- Manage vendor relationships and oversee contracts/budgets.
- Support KOL engagement, advisory boards, and medical education initiatives.
Compliance & Risk Management
- Ensure adherence to ethical guidelines, data integrity standards, and global regulatory requirements.
- Collaborate with Legal and Compliance to mitigate risks in medical content and activities.
Budget & Resource Management
- Oversee annual budgeting, resource allocation, and financial reporting for Medical Affairs programs.
- Negotiate vendor contracts and track expenditures to ensure cost-effectiveness.
- Track MA spend to support Finance in achieving financial targets.
About You (Qualifications)
- Demonstrated track record executing medical and/or scientific plans supporting product development and differentiation and healthcare stakeholder requirements.
- Demonstrated ability in strategic planning and resource management.
- Strong knowledge and application of ICH GCP, GxP, global regulations, and good document management practices.
- Experience leading and motivating cross-functional teams and vendors/consultants.
- Excellent interpersonal skills; ability to respond to multiple queries and handle conflict constructively.
- Success in a fast-paced, matrixed organization partnering with internal and external stakeholders.
- Advanced degree (MD, PhD, PharmD, or equivalent) in life sciences preferred.
- At least 5–7 years experience in Medical Affairs and/or Clinical Development in biotechnology/pharmaceutical industry.
- Experience in Compliance and/or Governance functions in biotechnology/pharmaceutical industry.
- Experience with novel modalities (gene editing, CRISPR, genetic medicines) preferred.
- Ability to sit or stand for multiple hours at a computer; manual dexterity for keyboarding.
- Travel up to 25% for HQ meetings, conferences, and internal training sessions.
Application Instructions
- Applications are accepted on a rolling basis until the position is filled (then the posting will be taken down).
The Director of Medical Operations will lead the operational strategy and execution of Medical Affairs initiatives, ensuring alignment with organizational goals. This role optimizes processes, manages cross-functional projects, and supports the Medical Affairs team in delivering high-impact medical strategies, with strong leadership and operational expertise and knowledge of biotech compliance and regulatory landscapes.
Responsibilities
Strategic & Operational Leadership
- Develop and implement operational strategies to streamline Medical Affairs activities, including medical communications, publications, medical information, and congress planning.
- Oversee the creation and maintenance of SOPs to ensure compliance with FDA, EMA, ICH-GCP, and company policies.
- Drive process improvements to enhance efficiency and scalability.
Cross-Functional Collaboration
- Partner with Clinical Development, Regulatory Affairs, Commercial, and R&D to align medical operations with corporate objectives.
- Manage vendor relationships and oversee contracts/budgets.
- Support KOL engagement, advisory boards, and medical education initiatives.
Compliance & Risk Management
- Ensure adherence to ethical guidelines, data integrity standards, and global regulatory requirements.
- Collaborate with Legal and Compliance to mitigate risks in medical content and activities.
Budget & Resource Management
- Oversee annual budgeting, resource allocation, and financial reporting for Medical Affairs programs.
- Negotiate vendor contracts and track expenditures to ensure cost-effectiveness.
- Track MA spend to support Finance in achieving financial targets.
About You (Qualifications)
- Demonstrated track record executing medical and/or scientific plans supporting product development and differentiation and healthcare stakeholder requirements.
- Demonstrated ability in strategic planning and resource management.
- Strong knowledge and application of ICH GCP, GxP, global regulations, and good document management practices.
- Experience leading and motivating cross-functional teams and vendors/consultants.
- Excellent interpersonal skills; ability to respond to multiple queries and handle conflict constructively.
- Success in a fast-paced, matrixed organization partnering with internal and external stakeholders.
- Advanced degree (MD, PhD, PharmD, or equivalent) in life sciences preferred.
- At least 5–7 years experience in Medical Affairs and/or Clinical Development in biotechnology/pharmaceutical industry.
- Experience in Compliance and/or Governance functions in biotechnology/pharmaceutical industry.
- Experience with novel modalities (gene editing, CRISPR, genetic medicines) preferred.
- Ability to sit or stand for multiple hours at a computer; manual dexterity for keyboarding.
- Travel up to 25% for HQ meetings, conferences, and internal training sessions.
Application Instructions
- Applications are accepted on a rolling basis until the position is filled (then the posting will be taken down).