Head of Medical Affairs

Head of Medical Affairs

Viridian Therapeutics, Inc.
Waltham, MA

At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Chief Medical Officer, the Head of Medical Affairs will be responsible for providing strategic leadership for all Medical Affairs related activities through the development and execution of the Medical Affairs strategy and tactics that are aligned with corporate goals, priorities and objectives. The ideal candidate will have a strong background in autoimmune disorders, coupled with a proven track record in Medical Affairs leadership.

Key responsibilities include, but are not limited to external stakeholder engagement, operational excellence/compliance, scientific integrity/communication and strategic leadership.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

• Lead cross-functional initiatives with R&D, regulatory, commercial, and market access teams
• Guide therapeutic area strategies and ensure scientific alignment across regions
• Ensure scientific integrity and accuracy in all medical communications, publications, and promotional material
• Build strong relationships and partnerships with the scientific and medical community including collaboration, support and management of corporate office and field-based team members to support successful implementation of Medical Affairs plan
• Development and/or oversight of the scientific platform across therapeutic areas including evidence generation plan
• Develop and execute plans for dissemination of medical and scientific information including data from clinical research, medical education programs (e.g., advisory boards, symposia) and medical conferences
• Develop and oversee the management of a system to track, manage and respond to unsolicited requests for medical inquiries across therapeutic areas
• Develop and implement a data sharing policy and process
• Build, lead, train and oversee appropriately sized field-based and operational medical affairs teams
• Partner with Viridian’s commercial team to ensure appropriate complaint field-based activities
• Ensure all medical activities comply with global regulatory requirements and ethical standards
• Champion a culture of compliance and scientific excellence including leading internal audits and risk assessments related to medical affairs operations
• Collaborate with clinical development teams to define real-world evidence and post-marketing study needs to support product adoption and expansion
• Contribute to early-stage clinical development by shaping clinical programs, ensuring scientific relevance, and aligning with patient and market needs
• Provide strategic input to ensure medical insights are integrated into payer strategies, health economics, and outcomes research (HEOR) plans
• Develop and oversee process for review and approval of Investigator Initiated Studies
• Oversee the review and approval of grants, including ACCME accredited CME programs, and sponsor ships in compliance with internal policies and/or procedures and external guidelines
• Develop and execute strategic Phase 3b/4 trials
• Identify strategies and tactics to support clinical development and clinical operations on the execution of clinical trials (e.g., site identification, patient recruitment)
• Drive a high-performance culture by fostering personal accountability and a commitment for results
• Manage the departmental budget

• MD (preferred), PhD, or Pharm
  
  D degree with 20+ years of experience, including 10+ years of management level experience in the biotechnology and/or pharmaceutical industry
• Proven track record of
  1) leading and building a high-performing Medical Affairs organization in a small/medium biotech and
  2) strategic and tactical planning for product launch (US and global)
• Proven track record of working cross functionally on strategic planning
• Direct involvement…