Senior Director, Legal Counsel (Commercial)

Cytokineticsis 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.

Key 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

Qualifications:

• 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.

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Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.

Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer