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Senior Counsel - Research & Development

Date: Feb 11, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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 challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

 

The Senior Counsel – Research & Development is primarily responsible for advising and collaborating with stakeholders in R&D, business development and clinical organization in support of investigational assets and a broad range of R&D-related activities.   The successful candidate will meet with R&D/BD, clinical and medical affairs clients and offer solution-oriented approaches to help achieve their business objectives.   He/she will also be expected to learn and understand new scientific approaches as necessary to support this work.    As a dedicated strategic partner, the Senior Counsel will:

 

  • Review, interpret, negotiate and draft various transactions in support of R&D strategic imperatives such as industry collaborations (selective program/product/field/territory in/out licensing, term sheets, M&A, JV, alliance, evaluation and option arrangements), academic collaborations (in-licenses, sponsored research, research collaborations, material transfer agreements), clinical trial related agreement, investigator-initiated trial agreements, and consortiums.
  • Provide legal support and guidance issues arising in research and development, pharmacovigilance, regulatory, compliance, including all applicable GxP requirements. This is an opportunity to work collaboratively cross-functionally with stakeholders in research, business development, alliance management, medical affairs, new product planning, and other business functions to support R&D initiatives. 
  • Responsible for providing practical and timely legal guidance on issues related to scientific, medical and clinical initiatives, Scientific Congresses, scientific educational programs and advisory boards.
  • Advise stakeholders on legal issues risk, will review corporate policies and procedures and assist the Associate General Counsel- Global Research and Development on other legal projects as-needed.He/she may serve as a legal representative on confidential projects, perform due diligence or facilitate risk assessments.  The Senior Counsel represents 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 General Counsel.

 

Responsibilites

 

Draft, negotiate and advise on partnering agreements that support R&D business objectives, including but not limited to:  academic and industry collaborations, sponsored research, clinical trial related agreements, licenses, option agreements; advise cross-functional teams on legal risk while still facilitating innovation; perform due diligence and activities related to legal assessment of potential assets.

Advise and provide legal guidance to support business initiatives to stakeholders in research, business development, medical affairs, regulatory, clinical, commercial development 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.

 

Education and Experience Requirements

 

  • Generally has 7 years of related experience at a major law firm or in-house experience with a major pharmaceutical and/or biotech company. 
  • Juris Doctor (JD) in at least one jurisdiction is required.
  • Extensive transactional experience, including drafting and negotiating a wide variety of agreements and the ability to influence and work collaboratively at all levels and across functions.
  • Knowledge of issues impacting clinical research and development, such as informed consent, patient recruitment, contractual arrangements with investigators, IND submissions, CMC and GxP matters, and other legal aspects of regulatory compliance involved in R&D activities, particularly for cell and gene therapy, a plus.
  • General familiarity with the laws and regulations governing the pharmaceutical industry, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code and HIPAA.
  • Ability to build credibility and communicate effectively with individuals and teams in Spark functions and to inspire confidence and support for legal department initiatives.  ​​​​​​

 

 Key Skills, Abilities, and Competencies

 

  • Excellent analytical, problem-solving, and communication skills
  • Strong collaboration, critical thinking, and negotiation skills to influence cross-functional teams
  • Proven experience building and cultivating relationships with key partners and stakeholders across all organizational levels
  • Able to thrive in a fast-paced environment and successfully manage multiple deadlines
  • Abiding interest in and knowledge of the burgeoning gene therapy industry

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Nearest Major Market: Philadelphia