Senior Director, Medical Affairs

Role Summary

Senior Director, Medical Affairs leads the global medical affairs strategy and execution for the portfolio, overseeing MSLs and Field Research Specialists, and driving KOL engagement. They develop and implement advisory boards, scientific and medical education programs, and ensure medical communications and publications align with therapeutic area goals. They provide medical affairs expertise to product development and cross-functional teams, establish academic collaborations, and manage team operations and compliance. Based in Irvine, CA with up to 35% travel.

Responsibilities

• Develop and drive the global medical affairs strategic and tactical plans.
• Lead the MSL organization and Field Research Specialists; drive KOL/PI/site-level engagement programs.
• Oversee the development and execution of advisory boards, scientific and medical education programs; provide scientific/medical education to internal stakeholders.
• Formulate evidence plans and organize activities based on project life cycles and stakeholder feedback.
• Support the strategic development and execution of publication plans and scientific communications for clinical programs.
• Oversee Medical Information Request processes, copy approval, and support field-based educational and promotional materials for scientific accuracy.
• Provide medical affairs expertise to product development and medical affairs teams, including cross-functional training.
• Partner with commercial and clinical development to support product strategy based on external and internal input.
• Establish academic cooperation and maintain communication channels with medical experts in relevant disease areas.
• Manage operational aspects of the teams (budget, performance, compliance) and implement workforce and succession plans.
• Proactively align Credo and Leadership Imperatives with team and enterprise strategies and goals.

Qualifications

• Required: Doctorate degree (e.g., PhD, MD, DVM, or equivalent) in biosciences, medicine, bioengineering, or related field.
• Required: Minimum of 10 years’ experience managing a senior scientific staff (PhD, DVM, MD).
• Preferred: Minimum of 10 years’ experience in a medical device industry.
• Preferred: SME in electrophysiology and/or cardiology.
• Required: Extensive knowledge of regulatory submissions for FDA and international agencies (e.g., TUV and EU MDR) with a proven track record of successful approvals.
• Required: Deep knowledge of AdvaMed Code and proven track record of leading compliance across the Medical Affairs Organization.
• Required: Ability to partner collaboratively with various functions in a challenging and changing environment.
• Required: Demonstrated leadership skills to act as a change agent, identifying needs and implementing solutions.

Skills

• Required: EU Regulations, FDA Regulations, Medical Device Regulations, Regulatory Approvals, Regulatory Submissions
• Preferred: Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Process Optimization, Product Strategies, Stakeholder Analysis, Strategic Thinking

Additional Requirements

• Must possess high emotional intelligence; excellent oral and written communication skills; excellent interpersonal skills for interactions with internal colleagues and external customers.
• Ability to lead, inspire and influence a team in a matrixed structure through change and in alignment with the strategic direction of the Scientific Affairs leadership team.
• Self-reflective and open to feedback and self-improvement.
• Demonstrated business acumen to understand implications of preclinical decisions.
• A proven ability to execute and get results through leading others in complex technical organizations while leading by example.
• Demonstrated ability to build successful relationships and develop partnerships with key business partners and investigators.
• A risk-taker who anticipates and mitigates risks or unintended circumstances.
• Travel up to 35% domestically and internationally.