BioSpace, Inc.
Executive Director and Product Counsel
BioSpace, Inc., San Diego, California, United States, 92189
Job Details
Strive to Bring a Profound Difference to our PatientsAt 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™). 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 Responsibilities
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 needsPosition Requirements
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 requiredAbility to effectively work with and manage a number of vendors supporting the Company's legal efforts across the world.What We will Provide to You:
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.
Strive to Bring a Profound Difference to our PatientsAt 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™). 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 Responsibilities
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 needsPosition Requirements
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 requiredAbility to effectively work with and manage a number of vendors supporting the Company's legal efforts across the world.What We will Provide to You:
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.