Avidity Biosciences Careers

Description

Company Overview 

At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.  

Position Summary:

Avidity is seeking a strategic, dynamic, and innovative Vice President, Global Medical Affairs, reporting to the Chief Medical Officer (CMO). The Vice President, Global Medical Affairs will be responsible for creating and building the global medical affairs function at Avidity.

In collaboration with executive leadership and the Avidity commercial and market access organizations, the Vice President, Global Medical Affairs will define medical affairs strategy and goals, develop and implement Medical Affairs plans, policies and procedures, and develop and oversee implementation of plans for scientific engagement with health care practitioners, research groups, payers, and patient advocacy groups throughout the company. Provides thought leadership and oversight for medical publication planning, medical education, medical information system development, field medical liaisons, medical communication and patient advocacy. Works closely with the clinical development, market planning, commercial, corporate communications and regulatory professionals as well as strategic alliance partners.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Build and oversee the global medical affairs organization in compliance with applicable regulations and industry codes of practice
• Develop and implement the global Medical Affairs strategic plan across products, including, but not limited to:
• Develop, implement and maintain Medical Affairs policies and procedures and SOPs to ensure compliance with applicable regulations and industry codes of practice
• Develop and oversee early access program strategy for each product, as required
• Develop strategy for review and approval of investigator-initiated studies, as required
• Build and oversee Field Medical, Medical Communication/Education, Medical Information, and Patient Engagement functions suitable for pre, peri and post approval activities
• Build a Medical Information function to respond to external requests for information
• Foster relationships with key research centers globally
• Authorizing and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content
• Develop and lead KOL speaker programs
• Work with research, clinical and commercial colleagues to develop and implement publication strategies across Avidity programs
• Work with internal and external stakeholders to implement scientific advisory boards and steering committees, expert focus groups etc.
• Develop and implement CME strategy
• Will have a strong understanding of all aspects of Avidity products, related disease states and related products in the marketplace
• Provide Medical expertise to the Commercial organization as needed to assist in the development and execution of compliant commercial activities
• Represent company externally, oversee medical affairs aspects of development and pre-launch scientific exchange
• Support preparation of clinical sections of relevant regulatory filings, as necessary
• Work closely with market planning, commercial and clinical development to support development of target product profiles, commercial forecasting, launch pans and life cycle management

• Work closely with clinical development to support growth and maintenance of Key Opinion Leader networks to meet company objectives with respect to exchange of scientific information, education relating to Avidity products and disease areas, and commercial planning
• Role may expand to include post-approval studies such as registry studies, post-market surveillance studies, or Phase 4/lifecycle management studies

Education and Experience:

• MD, DO, PharmD or PhD
• 16+ years of medical affairs experience in a pharmaceutical/biotech setting
• 5+ years of proven Medical Affairs leadership, building and implementing a successful global Medical Affairs strategy and infrastructure in both pre-launch and post-marketing settings
• Strong track-record in in rare disease medical affairs; neurology also an advantage
• Experience managing and managing direct reports, building teams and leveraging relationships with clinical and commercial teams
• Broad working knowledge of industry compliance requirements in USA and EU, clinical trial design and strategies, commercial and publication strategy, and medical information process
• Excellent written, communication, presentation and interpersonal skills
• Ability to work collaboratively at all levels in a matrixed team environment
• Excellent team management skills, ability to lead, train and mentor team members at all levels
• A self-starter with hands-on approach to performing duties and excellent attention to detail
• Strong customer focus

Travel:

You may be required to travel for up to 30% of your time.

Salary Range: $325,000 - $395,000 - Salary commensurate with experience