Senior Director, Legal Counsel (Commercial)
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.
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.
Pay Range
In the U.S., the hiring pay range for fully qualified candidates is $274,500-$368,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
_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 our General Data Protection Regulation (GDPR) policy PRIOR 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.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here Are Some Ways To Check For Authenticity
- We do not conduct job interviews through non-standard text messaging applications
- We will never request personal information such as banking details until after an official offer has been accepted and verified
- We will never request that you purchase equipment or other items when interviewing or hiring
- If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
