Executive Director, Medical Affairs

Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking an Executive Director, Medical Affairs who will be instrumental in creating and building the global medical affairs function at Precigen for our first commercial launch.

In collaboration with executive leadership, the Executive Director, Medical Affairs will define the Medical Affairs strategy, advance collaborations with key opinion leaders and lays out plans for scientific engagement with health care practitioners, research groups, payers, and patient advocacy groups throughout the company. Provide thought leadership and tactical execution for medical publication planning, medical education, medical information system development, field medical liaisons, and medical communication while working closely with the clinical development and regulatory teams.

The Executive Director, Medical Affairs must have the ability to maintain scientific credibility while being commercially supportive, to communicate scientific results and effectively respond to medical inquiries from customers and key stakeholders.

DUTIES AND RESPONSIBILITIES:

• Lead the development and implement the Medical Affairs strategic plan across Precigen’s portfolio.
• Medical affairs product lifecycle management and launch readiness plans
• Execute the delivery of timely, accurate and succinct communication of fair-balanced clinical and scientific presentations to healthcare professionals, both proactively and in response to requests for information, consistent with promotional compliance and regulatory requirements
• Lead Medical Affairs in the communication of scientific data to various audiences in the pre- and post-launch periods; including presentations at medical congresses as needed
• Create current and future competitive advantages by understanding and addressing patient needs and demonstrating a deep understanding of competitors’ strategies
• Build on established professional relationships with the Key Opinion Leaders community and develop new relationships as appropriate to exchange scientific knowledge and identify current and future business opportunities
• Broaden Precigen’s network and presence by strengthening scientific, academic, and KOL relationships
• Execute on Medical Affairs strategic imperatives and tactical plans to enhance healthcare practitioner education and improve patient outcomes.
• Develop, refine and implement all required Medical Affairs policies and procedures and SOPs.
• Provide Medical expertise to the Commercial organization as needed to assist in the development and execution of compliant commercial activities.
• Work closely with commercial and clinical development in writing target product profiles, forecasting life cycle management opportunities.
• Represent company externally, oversee medical affairs aspects of development and pre-launch scientific exchange needs.
• Contribute to scientific affairs by authorizing and/or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
• Partner with marketing, market access and commercial operations in developing launch plans
• Domestic Travel of 25-30%

EDUCATION AND EXPERIENCE:

• Degree of Medicine; Board certification or equivalent in Oncology
• 10+ years of Medical Affairs experience in a pharmaceutical/biotech setting.
• 5+ years of proven Medical Affairs leadership, building and implementing a successful Medical Affairs strategy and infrastructure
• Experience managing direct reports, building teams and leveraging relationships with clinical and commercial teams.
• A hands-on approach to performing duties with a strong self-directed work ethic and attention to detail.
• Extensive and recent product launch experience in oncology, having successfully launched key products/brands preferred
• Broad working knowledge of FDA requirements, industry compliance, clinical trial design and strategies, commercial and publication strategy, and medical information process.
• Excellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environment.
• Effective presentation skills to key stakeholders and key decision makers.
• Ability to work collaboratively across the organization to achieve corporate objectives.
• Excellent team management skills, ability to lead, train and mentor team members at all levels.
• Ability to set and follow through goals with a sense of urgency while keeping broader strategic objectives in focus.
• Thorough understanding of the U.S. medical affairs dynamics

DESIRED KEY COMPETENCIES:

• Extensive understanding of and experience in both the clinical aspects and business of oncology, ideally cell & gene therapy specifically
• Executive presence; 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 function.
• A thorough understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology, as well as the emerging paradigm for cell & gene therapy
• 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.

EOE MFDV

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. We invite you to discover more at www.precigen.com.

#LI-ONSITE #LI-AZ1