Executive Director and Product Counsel
- Employer
- Avidity Biosciences
- Location
- San Diego, California
- Start date
- Nov 10, 2024
View more categoriesView less categories
- Discipline
- Marketing, Product Development/Management, Regulatory, Legal/Compliance
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach
Job Details
- Serve as lead counsel for Avidity’s late-stage pipeline programs approaching regulatory filings and potential commercialization.
- Provide legal advice and counseling on a broad set of healthcare, commercial and general corporate topics in support of preparations for potential future commercial product launches, including but not limited to pre-approval activities, marketing strategies, promotional tactics and materials, advertising campaigns and programs, disease awareness activities, collaborating with/supporting patient advocacy groups, healthcare professional (HCP) engagements, advisory boards and interactions with others in a position to influence healthcare decisions (e.g., payers, distributors, etc.).
- Serve as the primary legal support and contact for the Global Commercial and Global Medical Affairs teams for commercialization activities.
- Advise clients on issues related to advertising and promotion of pharmaceutical products (including FDA regulations, Anti-Kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, Sunshine Act, Food and Drug Cosmetic Act, Medicaid Best Price, etc.).
- Review and approve scientific, disease state and promotional campaigns as well as provide legal counsel on internal product review committee; and provide guidance regarding promotional and non-promotional activities.
- Advise on matters related to reimbursement activities, access services, patient support and advocacy, and assistance programs. Including assist and advise on government pricing matters.
- Draft and negotiate a variety of third party contracts, including service agreements with consultants, market research entities, wholesalers, retail pharmacies, group purchasing organizations and distributors.
- Provide ongoing legal advice to key stakeholders relating to Avidity’s Corporate Compliance Program and Code of Business Conduct and Ethics.
- Provide legal guidance to the Commercial and Medical Affairs organizations on daily activities and special projects (including, but not limited to, review of commercial, development & marketing strategies).
- Review and approve scientific, disease state and promotional campaigns as well as provide legal counsel on internal product review committee; and provide guidance regarding promotional and non-promotional activities.
- Review and approve grants, medical education program activities and charitable contributions.
- Address a broad array of legal matters to support the company's business, working closely with other members of the Legal team, as well as internal business clients across functions.
- Help develop, manage and implement Legal's policies, playbooks, templates and procedures.
- Mentor and/or lead indirect teams.
- Help manage and work directly with external counsel supporting business needs
- Juris Doctor degree with exceptional academic credentials.
- Motivated to help make a difference in the lives of patients and families living with rare diseases.
- Prior drug launch experience for innovative first and/or best in class therapies, preferably in the rare disease space.
- 10+ years of relevant attorney experience, including training at a leading law firm’s life sciences practice and time spent in-house, ideally at a leading public biotech, pharmaceutical or life sciences company, in roles of increasing responsibility, and with experience as a product and regulatory lawyer.
- Must be admitted, active and in good standing with the California State Bar, or with another state bar and registered, or eligible to register, as in-house counsel with the State of California. Preference given for San Diego based candidates.
- Ability to work in a hybrid environment and in person in Avidity’s San Diego, California headquarters.
- Demonstrated excellent communication (oral and written), teamwork, presentation, training, organizational, interpersonal, and problem-solving skills.
- High level of curiosity, intelligence, ability to work independently while being a team player who brings a positive, "can do" attitude, who works collaboratively with other members of the Legal team and cross functionally.
- Be able to simultaneously manage workloads, multiple client demands and shifting priorities within a fast-paced, high-intensity and dynamic environment.
- Passion for the patient and to make a difference.
- Have impeccable professional ethics, integrity and judgment.
- Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization.
- Entrepreneurial mindset and ability to prioritize key workstreams, with a passion for results.
- Strong initiative and follow through are essential for this job.
- Exceptional verbal and written communication skills coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision.
- Be a collegial, hard-working, confident self-starter, able to build strong networks throughout the organization.
- Demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required
- Ability to effectively work with and manage a number of vendors supporting the Company’s legal efforts across the world.
- The base salary range for this role is $295,300 - $326,400. 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.
Company
Our vision is to profoundly improve people’s lives by revolutionizing the delivery of RNA therapeutics. We’re utilizing our proprietary AOC platform to design, engineer, and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) with the precision of oligonucleotide-based therapies in order to redefine RNA therapeutics and more effectively target underlying genetic drivers of diseases. We are delivering on this vision by investing in our platform, our pipeline and our people.
Our commitment to rigorous and innovative science is matched only by our passion to see patients’ lives changed. We consistently challenge ourselves to Be AVID – Agile, Visionary, Integrated and Diverse.
We are assembling a diverse team experienced in rare disease and RNA therapies. Our team members bring expertise in research, development and commercial execution. We are focused on cultivating the right team to not only grow the company, but also to reflect the communities we serve. We are dedicated to employing and retaining a diverse and inclusive workforce at all levels of the organization to not only ensure that different backgrounds and perspectives are being heard and acted upon, but that our employees also feel understood, accepted and valued.
- Website
- http://www.aviditybiosciences.com/
- Phone
- 858-401-7900
- Location
-
10578 Science Center Drive
Suite 125
San Diego
California
92121
US
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