National Senior Director, Field Medical Affairs

Responsibilities

• Establish, grow, and lead the national field-based MSL team, including defining operational frameworks, best practices, and standard operating procedures
• Ensure high standards of scientific and operational excellence through effective recruitment, training, mentorship, and performance management
• Translate overarching medical strategy into clear, actionable goals and measurable field medical initiatives
• Lead the identification and strategic engagement of key thought leaders and external experts in alignment with the medical strategy
• Oversee field-based support of clinical trials, including site education, patient recruitment, and investigator engagement
• Represent the organization at scientific conferences and participate in advisory boards and other scientific forums
• Build MSL team infrastructure for compliant scientific insight and data collection, MSL training and SOPs; direct the team on CRM operations
• Oversee MSL scientific engagements & activities that support compliant interactions with KOLs/HCPs and key stakeholders and guide the collection and dissemination of actionable insights that inform internal strategies relevant to the medical and clinical development landscape
• Work within the team to bring alignment & collaboration across products, disease states and indications
• Support MA by engaging with cross functional teams on business planning, special projects & strategic imperatives as assigned, including working with cross functional partners to optimally lead and support congress planning & execution
• Direct MSL activities to ensure the highest ethical standards & compliance with all applicable laws, regulations, industry codes, policies, SOPs, OIG, FDA, PharMA guidelines & the Orca Bio Code of Conduct
• Maintain scientific and clinical expertise through continuous education and attendance at key meetings and symposia
• Collaborate with in-house teams on publications, training, internal initiatives, and development of medical resources
• Other duties as assigned

Minimum Experience, Education, Certifications, Licenses

• Advanced scientific degree required, doctorate level clinical/medical degree (MD, PharmD, PhD)
• 8+ years’ experience within Medical Affairs, experience working as an MSL and at least 3 years of experience managing field-based MSL teams
• This leadership position requires excellent communication and interpersonal skills, motivation, initiative, mentoring, strategic thinking, problem solving, planning, & organizational skills
• Strong understanding of US pharma rules and regulations, particularly as they apply to MSL activities; ability to develop, coach & oversee a highly compliant MSL function
• Experience in team management, developing, reporting, & tracking MSL performance
• Experience with managing departmental projects & resources
• Experience with managing & developing relationships with key opinion leaders (KOLs)/health care professional (HCPs)

Preferred

• Cell and/or gene therapy experience
• Experience working in a small biotech company or start-up environment
• Demonstrated success in field medical launch planning and execution

Reporting Structure & Authority

Direct reports include: Field based Medical Science Liaison Team. Direct Supervisory responsibilities including decision-making authority recruitment, training, mentorship, and performance management.

Training & Continuous Improvement

Mandatory training: compliant scientific exchange, protected health information, preapproval information exchange, adverse event and quality complaint reporting, regulations regarding prescription drug advertising and promotion.

Travel Requirements

Domestic and international travel will be required from time to time as needed (approximately 40-50%).