Sr. Director, Regulatory Affairs Ad/Promo - Avidity Biosciences

Job Title:

Sr. Director, Regulatory Affairs Ad/Promo

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Regulatory Affairs

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. 

Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.

The Opportunity

We are seeking a highly experienced and motivated Sr. Director of Regulatory Affairs Advertising and Promotion (Ad/Promo) to join our fast-paced and growing organization. This position requires excellent leadership, communication, people management skills and keen judgement. The Sr. Director of Reg Affairs Ad/Promo will provide compliant and commercial regulatory strategy with a patient-focused mindset. The ideal candidate will contribute to global product labeling strategy and development.

This position will work closely with commercial/launch teams, medical affairs, research and development, corporate communications, legal and executive management to ensure promotional communications are compliant with regulatory requirements and align with strategic objectives. Leading health authority interactions as they pertain to Advertising and Promotion and Commercial Labeling.

What You Will Contribute

• Serves as the subject matter expert for Regulatory AdPromo at Avidity, providing leadership and development of innovative and compliant strategies to support communication and promotional objectives.
• Lead the development and implementation of guidelines and processes for the creation, review, approval and regulatory submission of promotional content.
• Co-chair the global labeling teams which assume responsibility for creation, review, approval and lifecycle management of the Company Core Data Sheet and prescribing information.
• The role will include reviewing proposed promotional communications including labeling, advertising campaigns, digital and DTC marketing, corporate presentations and press releases, scientific communications and promotional exhibits to ensure compliance with regulations and company policies.
• Key priorities will include collaboration with cross-functional teams to plan, prioritize and execute OPDP submissions.
• Lead risk assessment and management activities related to advertising, promotion, labeling and operations, developing strategies to mitigate risks and correct issues.
• Evaluate the effectiveness and regulatory compliance of promotional activities, making adjustments as necessary to address compliance issues or regulatory concerns.
• Supervise one or more RA staff, providing mentorship and support career growth opportunities leading to excellence and continuous improvement.
• Demonstrate an ability to master scientific and clinical content to enable critical evaluation of commercial campaign strategies and promotional pieces in relation to available data.
• Communicate effectively within RA department, on cross-functional teams, and effectively direct contractors or consultants to provide high quality and on-time work product.
• Maintain high level of aptitude with emerging global regulatory policies and requirements to enable Avidity to evolve compliant policies and business priorities accordingly.
• Facile with document management systems (e.g., Veeva PromoMats) and willing to provide guidance to new users as required to meet objectives.
• Keep RA management informed on status and timelines of important submissions.
• Maintain awareness of current regulatory guidance, best practices, and technology advances to ensure Avidity systems and/or processes, projects and initiatives are efficient and compliant.

What We Seek

• Bachelor’s Degree required; Advanced Degree preferred
• 15+ years of industry experience, including dynamic Regulatory Ad/Promo leadership position(s)
• Supervisory experience (multiple employees preferred) with a demonstrated commitment to employee career growth and development.
• Demonstrated experience in Regulatory Ad/Promo with global commercial launches, commercial-stage products, including lifecycle and post-approval workstreams.
• Experience developing OPDP submission strategy a US accelerated approval scenario.
• Excellent verbal and written communication skills, including direct communication with Health Authority representatives.
• Demonstrated ability to independently lead, plan and execute a high volume of regulatory submissions.
• Thorough knowledge of US and international regulations as they apply to advertising and promotional communications, external communications and labeling.
• Collaborative spirit and ability to effectively partner with cross-functional leaders to develop efficient and compliant processes to enable development of appropriate content in the interest of promoting and protecting patient health.
• Self-organized, self-directed, and highly motivated.
• Strong critical thinking and analytical skills.
• Demonstrated ability to advocate for and influence best decision-making.
• Commitment to transparency, integrity and high standards in self and others.
• Enthusiastic to contribute to a continuous learning and process improvement environment.
• Skilled at negotiating with and managing external vendors to achieve excellent work product aligned with department and Brand objectives.

• The base salary range for this role is $248,000 – $322, 000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
• A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences

10578 Science Center Dr. Suite 125

San Diego, CA

92121

O: 858-401-7900

F: 858-401-7901