Director, Medical Affairs

Role Summary

Director, Medical Affairs will be instrumental in supporting Precigen's medical affairs function for the company’s first commercial launch. Reporting to the VP, Head of Medical Affairs, the role will define the Medical Affairs strategy, engage with key opinion leaders, and plan scientific engagement with health care practitioners, research groups, payers, and patient advocacy groups. The position provides thought leadership and executes medical publication planning, medical education, medical information, field medical liaison activities, and medical communications in collaboration with clinical development and regulatory teams. It requires maintaining scientific credibility while providing commercially appropriate support and responding to medical inquiries from customers and stakeholders.

Responsibilities

• Leads the tactical implementation of the Medical Affairs strategic plan across Precigen’s portfolio.
• Supports Medical Affairs product lifecycle management and launch readiness plans.
• Delivers timely, accurate, and balanced clinical and scientific communications to healthcare professionals, proactively and in response to information requests, in compliance with promotional and regulatory requirements.
• Leads Medical Affairs in communication of scientific data to audiences in pre- and post-launch periods.
• Creates competitive advantages by understanding patient needs and competitors’ strategies.
• Represents Precigen at medical meetings through Medical Affairs’ Scientific Booth coverage and related activities.
• Attends congresses as appropriate and develops internal congress reports.
• Represents Medical in the MLR process and ensures medical accuracy of materials; submits medical materials as needed.
• Creates and updates scientific materials (e.g., slide decks for field medical, medical narratives) ensuring fair balance and scientific accuracy.
• Executes Medical Affairs strategic imperatives and tactical plans to enhance healthcare practitioner education and improve patient outcomes.
• Develops, refines and implements all required Medical Affairs policies and procedures and SOPs.
• Provides Medical expertise to the Commercial organization as needed to assist in the development and execution of compliant commercial activities.
• Works closely with commercial and clinical development in writing target product profiles, forecasting life cycle management opportunities.
• Contributes to scientific affairs by authorizing and/or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
• Partners with marketing, market access and commercial operations in developing launch plans.
• Domestic travel: 20-25%

Qualifications

• Required: 5+ years of Medical Affairs experience in a pharmaceutical/biotech setting.
• Required: A hands-on approach to performing duties with a strong self-directed work ethic and attention to detail.
• Preferred: Product launch experience in oncology, having successfully launched key products/brands.
• Required: Broad working knowledge of industry compliance, clinical trial design publication strategy, and medical information process.
• Required: Excellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environment.
• Required: Effective presentation skills to key stakeholders and key decision makers.
• Required: Ability to work collaboratively across the organization to achieve corporate objectives.
• Required: Ability to set and follow through goals with a sense of urgency while keeping broader strategic objectives in focus.
• Required: Thorough understanding of the U.S. medical affairs dynamics.

Education

• Scientific Degree, MD preferred

Skills

• Extensive understanding of and experience in both the clinical aspects and business of oncology, ideally cell & gene therapy specifically
• Confident, positive attitude, enthusiastic and charismatic
• Value based collaborator – respectful, accountable and collaborative
• Self-motivated and independently minded
• Positive interpersonal skills with the ability to interact with individuals from a variety of levels and functions
• Understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology
• Self-organizer, meticulous hands-on habits, keen attention to detail
• Impactful written and verbal scientific communication
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Problem solving and risk-mitigation skills
• Appreciation of diversity and multiculturalism
• Strategic and creative thinker
• Ability to build working relations throughout the organization and with business partners to achieve business goals
• Strong time management and organizational skills
• Ability to manage multiple projects in a fast-paced environment
• Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.