Spark Therapeutics

Candidates must have demonstrated knowledge and experience in healthcare regulatory law (e.g., commercial, sales and marketing, managed care contracting) and clinical development, product strategy, and healthcare compliance in a biopharma/biotech company, as well as the statutes, regulations, and guidance documents applicable to these activities.. Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs.. Provide advice to and in collaboration with corporate compliance on interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy organizations; speaker programs; healthcare consultant activities; fair market value; grants, sponsorships and charitable contributions; publications; messaging and materials approvals; market research and market access activities; and safety information and product complaints to ensure compliance risks are well managed.. Provide transactional support for clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, government affairs, and other related agreements.. A minimum of 7 years of experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use or equivalent experience with an external law firm advising the biotech/biopharma/pharma industry in healthcare regulatory law, clinical development, product strategy, and/or healthcare compliance.

senior counsel

Join the Spark Team We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. We don’t follow footsteps. We create the path. Primary Duties Spark Therapeutics is a fully integrated, commercial gene therapy company dedicated to unlocking the power of gene therapy to accelerate healthcare transformation. We are looking for an experienced attorney to join our legal team and support the development, product strategy, and commercialization of gene therapies with our external and internal business partners. Candidates must have demonstrated knowledge and experience in healthcare regulatory law (e.g., commercial, sales and marketing, managed care contracting) and clinical development, product strategy, and healthcare compliance in a biopharma/biotech company, as well as the statutes, regulations, and guidance documents applicable to these activities. This opportunity is for applicants who enjoy working on innovative technologies in a collaborative and collegial environment. As a dedicated strategic partner, the Senior Counsel will: <ul><li> Provide transactional support for development, product strategy, and commercial agreements needing legal review and negotiation, including clinical study-related, payer, marketing, speaker, advisory board, consultant, and grant & sponsorship agreements. This support would involve partnering closely with the business to help achieve cross-functional operational goals while protecting the company's interests. </li><li> Provide clear, pragmatic, and high quality legal advice on a wide range of business activities relating to the development & product strategy and commercial organizations. </li><li> Provide legal advice on regulatory matters, including risks pertaining to FDA and other industry regulations concerning gene therapies. </li><li> Provide practical and timely legal guidance on issues related to clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, and government affairs. </li><li> Provide advice to and in collaboration with corporate compliance on interactions with healthcare professionals, healthcare organizations, patients, and patient advocacy organizations; speaker programs; healthcare consultant activities; fair market value; grants, sponsorships and charitable contributions; publications; messaging and materials approvals; market research and market access activities; and safety information and product complaints to ensure compliance risks are well managed. </li><li> Represent the legal group on various committees and teams that are convened by stakeholders as may be requested by those functions and the Associate General Counsel or Chief Legal Officer. </li><li> Assist the Associate General Counsel on other legal matters, as needed. </li></ul>Responsibilities Advise and provide legal guidance to support business initiatives for stakeholders in the development & product strategy, commercial, and corporate compliance organizations and other business functions in a manner that advances the company's strategy, addresses legal/regulatory risks, and maintains the company's integrity and reputation. Provide transactional support for clinical, biometric, medical affairs, patient advocacy, regulatory affairs, pharmacovigilance, program and asset management, commercial development, pricing & reimbursement, sales, marketing, market access, patient services, government affairs, and other related agreements. Support legal department initiatives and projects in furtherance of the growth, innovation and culture of the department and organization. Education And Experience Requirements <ul><li> Undergraduate degree from an accredited college or university. </li><li> JD or equivalent from an accredited law school. </li><li> A minimum of 7 years of experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use or equivalent experience with an external law firm advising the biotech/biopharma/pharma industry in healthcare regulatory law, clinical development, product strategy, and/or healthcare compliance. Experience prior to receiving a J.D. will also be considered. </li><li> Significant transactional experience, including drafting and negotiating a wide variety of agreements and the ability to influence and work collaboratively in a cross-functional setting with innovative technologies. </li><li> Bar membership in good standing and licensed to practice law in the Commonwealth of Pennsylvania or licensed to practice law in another jurisdiction and holding or qualified to hold a Pennsylvania Limited In-House Corporate License. </li><li> This role requires a minimum of three days a week in our Philadelphia office. </li></ul>Key Skills, Abilities, And Competencies <ul><li> Excellent analytical, problem-solving, and communication skills. </li><li> Strong collaboration, critical thinking, and negotiation skills to influence cross-functional teams. </li><li> Proven experience building and cultivating relationships with key partners and stakeholders across all organizational levels. </li><li> Ability to thrive in a fast-paced environment and successfully manage multiple deadlines. </li><li> Abiding interest in and knowledge of the burgeoning gene therapy industry. </li></ul>Complexity and Problem Solving <ul><li> Skilled attorney with desire for continuous learning and ability to serve and manage a variety of clients and complex matters in an evolving practice. </li><li> Collaborative and pragmatic advisor with ability to exercise independent judgement, and identify business, or legal issues for internal escalation and decision-making. </li><li> Experienced advisor with the ability to work independently and proactively to develop creative solutions to meet client and team needs. </li></ul>Internal and External Contacts Internal Contacts <ul><li> Members of the Development & Product Strategy organization </li><li> Members of the Commercial and Government Affairs organization </li><li> Members of the Spark Legal & Compliance organization </li></ul>External Contacts <ul><li> Law firms and other service providers and vendors </li><li> Members of Roche affiliate legal organizations </li></ul>Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $ 204,500.00 to $ 306,700.00 . Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

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