Head of Legal and Compliance, Associate General Counsel

Head of Legal and Compliance, Associate General Counsel

Office: USA  |  Location: US Site, REMOTE

• Company: Gamida Cell, Inc.
• Posting Title: Head of Legal and Compliance, Associate General Counsel
• Function: Commercial
• Location: Remote

Gamida Cell is a leader in advanced cellular therapies and hematopoietic stem cell transplantation, with two FDA approved therapies, Omisirge® (omidubicel-onlv) and APHEXDA® (motixafortide). Omisirge® is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy that is potentially curative for patients with hematologic malignancies. APHEXDA® is a CXCR4 antagonist with long receptor occupancy indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

General Scope and Summary

The Head of Legal and Compliance, Associate General Counsel (AGC) will report directly to the President of the US Business.  The AGC is responsible for overseeing and supporting Legal and Compliance activities with a focus on the US commercial business and daily business activities. This role will partner with stakeholders throughout the organization, to develop, refine, and/or implement practical ways to uphold the legal, regulatory, and ethical obligations of a pharmaceutical manufacturer in the oncology space.  This will include the development and implementation of legal and compliance processes and policies, as well as ensuring their appropriate evolution as the organization continues to grow. This individual must be someone who thrives in a fast-paced environment, is strategic, proactive, flexible, detail-oriented, and hands-on. This role sits on the US Leadership Team (USLT) and is an opportunity with high corporate visibility; as such, there is a lot of exposure to the global executive team and on occasion the Board of Directors as well.  This job will ask you to be both a teacher and a student, a problem-solver, and a self-starter. This is a job with a clear immediate focus, no shortage of challenging issues, great people, and the potential for meaningful future growth, as the company grows.

Roles and Responsibilities
The Head Compliance and Legal, Associate General Counsel will be responsible for the following activities which include, but are not limited, to:

• Provide strategic legal guidance on FDA law and regulations, anti-kickback statute, federal False Claims Act, and product liability matters to various functions (including with sales, marketing, medical affairs, market access, patient services, patient advocacy, and others) regarding product launches, brand planning, life-cycle management, and other initiatives.
• Provide legal review of promotional and non-promotional materials to ensure compliance with all relevant laws, regulations, industry guidance and company policies (i.e., Legal point on “MLR” a/k/a “PRC”).
• Collaborate with company leadership and employees at all levels to develop, implement and evolve a well-designed healthcare compliance program that works in practice.
• Provide operational input and legal advice on Federal Sunshine Act and state transparency reporting processes, including coordinating with Finance, and outside service providers, and other relevant functions to review data and manage an effective state and federal transparency reporting process; there is also a chance to shape the way the company thinks about this reporting, including education and counseling within the organization.
• Develop, implement and manage a business-enabling contracting process/system.
• Draft, negotiate, revise, and improve certain global healthcare and US business contracts including but not limited to CDA, MSA, collaboration agreements, investigator-initiated study agreements, supply chain agreements, and consulting agreements. Draft, and support in negotiation of, a variety of contracts (services agreements and commercial contracts with 3PLs, distributors, wholesalers, payors, specialty pharmacies, grants, sponsored research, speaker/consultant, licensing, collaboration, employment-related, leases, etc.).
• Implement and serve as Chair of Compliance Committee. Routinely report on Compliance Program and key findings to leadership.
• Help maintain compliance with the seven elements of a compliance program per OIG guidance.
• Develop and manage internal auditing and monitoring program, including, but not limited to, field ride alongs, speaker program monitoring, and advisory board monitoring.
• Implement written healthcare compliance policies and procedures, and continuously assess the need for revisions.
• Prepare and deliver compliance trainings, along with training plans for the organization.
• Conduct internal investigations. Engage and manage outside counsel in complex internal investigations.
• Manage department budget and legal/compliance-related outside counsel and consultant activities.
• 30% travel required, potentially including international.
• Other legal duties, as assigned, to support a growing diverse global company.

Experience, Education and Specialized Knowledge and Skills

• Required Commercial experience in Life Sciences.
• At least 10 years of recent relevant legal experience in Life Sciences.
• Licensed to practice law in one or more US jurisdictions.
• Experience supporting an active promotional review committee required.
• Familiarity with Sunshine reporting/aggregate spend rules and process.
• Demonstrated courageous leadership and organizational savvy necessary to collaborate effectively with cross-functional teams.
• Demonstrated success in proactively and independently driving for and delivering results with high impact.
• Excellent oral and written communications skills.
• Team player and strong collaboration skills.
• Detail oriented with demonstrated record of problem-solving.
• Strong ability to influence and present complex information to colleagues and tackle challenging issues beyond the core competencies.
• A team player who likes to learn, likes to teach, and can self-manage priorities, time, and projects.

Travel: 30% travel required, potentially including international.

Reports to: President of the US Business

Base Salary Range: Gamida Cell considers a range of factors when determining base compensation and therefore the final compensation will vary depending on experience level.