Share this Job

Associate General Counsel - Research & Development

Date: Jun 9, 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.

 

 

Primary Duties:

 

The Associate General Counsel – Research and Development (AGC R & D) is responsible for leading the legal function supporting the assigned research and development functions and issues (as described below). In that role, she or he anticipates and identifies legal risks and develops and articulates strategies to mitigate those risks; provides timely and expert counsel to the assigned research and development functions to support compliance with existing and anticipated legal obligations; and identifies and advances opportunities under the law that help drive innovation and support the company’s achievement of its mission and goals.

 

The AGC R & D will be responsible for providing legal support for the following Spark functions and issues:

 

  • All assets from discovery through the beginning of Phase 3 studies
  • Business Development related to R & D
  • Clinical Data Privacy
  • Research and Development
  • Pre-Clinical and Clinical
  • R & D agreements (including consents, Investigator Brochures)
  • Animal welfare
  • Regulatory Affairs
  • Regulatory Policy
  • Pharmacovigilance
  • Medical Information for relevant assets
  • Medical Communications (including publications and publications planning) for assigned assets
  • Competitive Intelligence
  • Asset Teams for assigned assets

 

 

The AGC R & D leads lawyers and professional legal staff assigned to research and development legal group, ensuring that work is prioritized and handled in an efficient and expert way consistent with the high standards set by the Company as reflected in its Mission and Code of Conduct and Business Ethics and supportive of achievement of the company’s goals.

 

The AGC R & D collaborates and interacts effectively with key stakeholders in the assigned research and development functions and issues to ensure she or he and her or his legal function remains current on issues affecting those functions and develops strong working relationships with those stakeholders.

 

The AGC R & D will represent the legal group on various committees and teams that are convened by the various assigned research and development functions as may be requested by those functions or by the GC.

 

The AGC R & D collaborates with and advises Corporate Compliance on issues and matters related to the assigned research and development functions to support the company’s compliance programs.

 

The AGC R & D is a member of the General Counsel’s leadership team and advises the GC and other members of the leadership team on developments in the assigned research and development functions, apprises and advises the GC on emerging legal issues and risks in those functions,  collaborates with the GC and the leadership team on strategies that mitigate legal risks that are companywide, and assists the GC in managing the legal function to ensure that it operates effectively and efficiently.

 

The AGC R & D will seek guidance and advice from external counsel as needed on novel, emerging, or complex legal issues and manage external counsel to ensure that such guidance and advice is provided effectively and efficiently. The AGC R & D will work with the GC and other members of the GC’s leadership team in evaluating the performance of external counsel.

 

The AGC R & D will lead or assist in the development of Spark internal and external policies and positions related to the assigned research and development functions and issues.

 

The AGC R & D will lead and develop members of her or his team to ensure that each of them works effectively and receives professional development and timely feedback and coaching.

 

 

Responsibilities:

% of Time

Job Function and Description

60%

 

Providing legal guidance to assigned research and development functions and issues as described above.

 

20%

 

Manage lawyers and other legal professionals (internal and external) supporting the research and development legal function to achieve business goals and objectives:

  • Foster Spark’s Culture.  Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
  • Hire & Integrate.  Know what skills, experiences, and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision, and Values.  Consciously create a team with diverse backgrounds, experiences, skill sets, and perspectives.  Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
  • Manage performance.   Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing.  Provide team members with continuous and ongoing performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions, and changes; adjusting goals as needed.
  • Develop people.   Understand each individual team member’s career goals. strengths and motivators.  Partner with your employees to identify areas for development, conduct coaching conversations regularly, and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.

 

20%

 

  • Assisting with the management of the legal function as a member of the GC’s leadership team.

 

 

Education and Experience Requirements:

 

  • Undergraduate degree from an accredited college or university;
  • JD or equivalent from an accredited law school;
  • 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;
  • Generally, 12 or more years of experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use or with other life-science regulated industries or equivalent experience with an external law firm advising the biotech/biopharma/pharma industry. Strong experience in global healthcare compliance or legal department(s) with a demonstrated deep understanding of the complex functions of a pharmaceutical organization and the associated legal, regulatory, and compliance matters of the industry.
  • Deep and well-rounded knowledge of applicable federal, state, and local laws and regulations that affect the regulated biotech/biopharma/pharma industry (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, industry guidance documents, CIA trends, Stark Law, HIPAA, GDPR, regulations regarding the promotion of marketed products, EFPIA and the False Claims Act, and Anti-Kickback Statutes).
  • Strong experience and expertise in the research and development of regulated biotechnology products, including the regulatory process and the management of clinical trials.
  • Experience with legal issues outside of the United States is desirable but not mandatory.
  • Experience in effectively managing people and leading teams.

 

 

Key Skills, Abilities, and Competencies:

 

  • Outstanding critical thinking and listening skills
  • Abiding interest in and knowledge of the burgeoning gene therapy industry
  • Excellent advocacy skills
  • Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with designing and presenting training materials
  • Demonstrated ability to operate in an entrepreneurial, responsive, and collaborative style focused on advancing Spark’s business priorities while ensuring adherence to the Company’s compliance programs and projects
  • Proven experience building and cultivating relationships with key partners and stakeholders across all organizational levels
  • Strong ability to build credibility and communicate effectively with individuals and teams in Spark functions and to inspire confidence and support for legal department initiatives
  • Strong collaboration, critical thinking, and negotiation skills to influence cross-functional teams in issue resolution
  • Ability to provide effective counsel while demonstrating discretion, confidentiality, and respect for colleagues
  • Impeccable ethics and integrity and commitment to reflect, support, and promote Spark’s values

 

 

Complexity and Problem Solving:

 

  • Anticipate and provide strategic counsel for mitigating legal risks that arise from the assigned research and development functions and issues.
  • Ability to think critically, strategically, and quickly analyze complex or novel legal issues
  • Ability to synthesize information from diverse sources, develop options for resolution, make decisions that are rational and based on sound evidence, and determine an action plan, as needed
  • Ability to oversee projects and successfully complete them in an organized, efficient, and effective manner
  • Ability to communicate information concisely and effectively to cross-functional business teams
  • Ability to work in a dynamic, fast-paced environment with shifting priorities and to interact successfully in a global company with a culturally diverse workforce

 

#LI-2326

 

 


Nearest Major Market: Philadelphia