Director, Global Regulatory Affairs Labeling

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare diseases, as an Associate Director of US Marketing Gene Therapy. Reporting to the Marketing Director, you will lead promotional programs for pre-launch and launch efforts in the US market, maximizing patient access to new treatments. You will develop marketing programs and resources, track their impact, and collaborate with cross-functional teams. The role requires significant experience in biopharmaceutical marketing, particularly within rare diseases, and strong leadership and communication skills. This remote position offers a competitive salary, bonus, equity incentives, and a comprehensive benefits package. Travel up to 30% within the US and occasional visits to the Brisbane, CA office are required.

Requirements

• BA/BS degree or equivalent life-sciences qualification required
• Minimum 7+ years of marketing and sales experience, with at least 5 years in marketing, in the biopharmaceutical industry
• At least 2 years of experience in rare/ultra-rare disease, experience with Metabolic Genetics and Gene Therapy highly desirable
• Successful candidates will have a proven ability to work in a multidisciplinary team with a high degree of collaborations, a strong patient focus and an understanding of U.S. patient access challenges
• Strong command of analytical and market research techniques with a proven ability to interpret market insights to help guide strategic direction and prioritize tactics
• Demonstrated ability to think strategically and act creatively to develop and lead innovative brand strategies and tactics
• Proven experience working with and managing external partners, including Advertising and Communications agencies
• Strong leadership and ability to drive influence across stakeholders to set direction, align work efforts and ensure flawless execution
• Proven ability to communicate complex scientific and clinical concepts to HCP and patient audience
• Excellent public presentation skills, written communication and listening skills

Responsibilities

• Lead promotional programs and develop resources for HCPs and patients in the preparation and execution of successful product launches
• Work closely with the Marketing Lead and National Sales Director to support a successful launch platform
• Develop and support US marketing initiatives, monitors the progress of these marketing initiatives and adjust appropriately to optimize patient access and key customer uptake
• Closely collaborate with Digital Lead to ensure the execution of non-personal promotion activities support and align to brand strategy
• Work closely with Marketing Director to develop short- and long-term strategic plans for pre-launch and launch products
• Manage HCP and patient congress/conferences – disease state and branded content in collaboration with the event management team, including messaging, booth design and coordinating onsite materials and field training
• Develop and lead promotional speaker bureau including agency oversight, speaker management, and content creation to support brand strategy
• Cultivate strong relationship with cross functional teams, including Medical Affairs, Commercial field organization, Training, Patient Services, Legal, Compliance, Regulatory Affairs, & Patient Advocacy to identify best practices and uncover need/trends for real time modification to enhance impact of campaign
• Primary contact with MRC (Medical, Regulatory, Legal) team and multiple agencies/vendors to ensure projects are completed on time and within budget scope
• Manage all assigned promotional activities within corporate and industry guidelines for ethics and compliance

Preferred Qualifications

• MBA preferred
• Prior product launch experience preferred

Benefits

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Annual bonus
• Equity incentives