Description:
Primary Duties:A Fully Integrated, Commercial Company 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 generalist attorney to join our legal team with deep expertise across the biotech/biopharma/pharma industry, including in commercial transactions. The Associate General Counsel (AGC) is responsible for directly leading the legal function supporting contracts processes and human and workplace resources and technologies, and for overseeing legal support for development & product strategy, commercial, patient supply, corporate compliance, and corporate communications. In that role, the AGC anticipates and identifies legal risks and develops and advances strategies to mitigate those risks; provides timely and expert counsel to the assigned functions to help ensure compliance with existing and anticipated legal obligations; identifies opportunities under the law that help drive innovation and support the company's achievement of its mission and goals and serves as a thought-partner with the assigned functions and areas.
Primary Responsibilities:
The AGC will be responsible for providing direct legal support for the following A Fully Integrated, Commercial Company functions and areas:
- Contracts Processes & Procurement
- Human Resources
- Information Technology
- Strategy
- Finance
- Litigation in the assigned areas
- Roche engagement in assigned areas
- Third-party agreements arising from assigned functions and issues
- Development & Product Strategy
- Commercial
- Corporate Compliance
- Patient Supply
- Corporate Communications
The AGC leads professional legal staff supporting the assigned functions, 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.
- Collaborates and interacts effectively with key stakeholders in the assigned functions and areas to ensure the legal group remains current on issues affecting those functions and develops strong working relationships with stakeholders.
- Represents the legal group on various committees and teams that are convened by the various supported functions and areas as may be requested by those functions and areas or by the Chief Legal Officer (CLO)..
- Collaborates with and advises Corporate Compliance on issues and matters related to the supported functions and areas in furtherance of the company's compliance programs.
- The AGC is a member of the CLO's leadership team and advises the CLO and other members of the leadership team on developments in the supported functions and areas, apprises and advises the CLO on emerging legal issues and risks in those functions and areas, collaborates with the CLO and the leadership team on strategies that mitigate legal risks that are companywide, and assists the CLO in managing the legal function to ensure that it operates effectively and efficiently.
- Seeks the 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 works with the CLO and other members of the CLO's leadership team in evaluating the performance and meeting company cost expectations of external counsel.
- Leads or assists in the development of A Fully Integrated, Commercial Company internal and external policies and positions related to the assigned functions and areas.
- Leads and develops members of the AGC's team to ensure that each of them works effectively and receives professional development and timely feedback and coaching.
Additional responsibilities include:
Manage lawyers and other legal professionals (internal and external) supporting the assigned functions and departments to achieve business goals and objectives:
- Foster A Fully Integrated, Commercial Company'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 on-going 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. Assist with the management of the legal function as a member of the CLO'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.
- A minimum of 12 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).
- Experience with legal issues outside of the United States is desirable but not mandatory.
- Broad experience across a number of areas in the biotech/biopharma/pharma industry, e.g., 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, manufacturing, supply chain, quality assurance, technical operations, engineering, real estate and corporate facilities, environmental health and safety, including on transactions and contracting processes.
- Experience with human resource issues and investigations, including federal, state, and local laws applicable to employer/employee relations, workplace discrimination and harassment and employee and data privacy.
- Experience in effectively managing people and developing 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.
- 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.
- 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 A Fully Integrated, Commercial Company'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 couns
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