Senior Director, Legal Counsel (Commercial)

Cytokinetics • Radnor, PA

3d • Hybrid

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. The Senior Director, Legal Counsel role is a specialized in-house role that bridges legal requirements with business objectives, particularly focusing on the development, commercialization, and sale of drug products. The successful candidate will provide strategic, proactive legal advice to departments including Marketing, Sales, and Medical Affairs, ensuring compliance with applicable pharmaceutical laws, regulations, codes and standards.

Requirements

• A Juris Doctor (JD) degree, with 10+ years of legal experience, including significant in-house experience in the pharmaceutical or biotechnology industry.
• Admitted to at least one state bar.
• Minimum of 10 years of experience as in-house counsel in a biotechnology, pharma or healthcare company or a combination of in-house at large public company and/or nationally recognized law firm specializing in the area of interest
• Regulatory Knowledge: Deep understanding of FDA and EMA regulations concerning drug development, marketing, and sales.
• Strategic Thinking: Strong analytical skills to evaluate complex legal risks and provide commercial, pragmatic solutions.
• Communication: Excellent interpersonal skills to influence stakeholders at all levels of management.
• Flexibility: Ability to work in a fast-paced, high-stakes environment.

Responsibilities

• Regulatory & Compliance Counseling: Advise on legal risks associated with promotional and non-promotional initiatives, ensuring compliance with FDA, EMA, and international regulations, as well as the Anti-Kickback Statute, False Claims Act, and OIG guidelines.
• Review Committee Participation: Actively participate in Medical/Legal/Regulatory (MLR) review teams, reviewing promotional materials, sales tactics, and social media for compliance with applicable law, regulations, standards and codes
• Product Launch & Lifecycle Management: Support product launch preparations, market development, and lifecycle management, including review of brand strategy and patient education materials.
• Business Partner Collaboration: Collaborate with Sales, Marketing, and Medical Affairs teams to provide legal solutions that meet business goals
• Commercial Contracting: Draft, negotiate, and interpret a wide range of commercial agreements, including master services agreements (MSAs), vendor agreements, consulting agreements

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree