Director, 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:

• 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.
• Provide clear, pragmatic, and high quality legal advice on a wide range of business activities relating to the development & product strategy and commercial organizations.
• Provide legal advice on regulatory matters, including risks pertaining to FDA and other industry regulations concerning gene therapies.
• 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.
• 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.
• Assist the Associate General Counsel on other legal matters, as needed.

 

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

• Undergraduate degree from an accredited college or university.
• JD or equivalent from an accredited law school.
• 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.
• 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.
• Bar membership in good standing and licensed to practice law in the Commonwealth of Pennsylvania or licensed to practice law in another jurisdicti