Intellectual PropertyExp.: 5 - 12 Years
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators as potential treatments for people with debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology research, we’re developing small molecule drug candidates specifically engineered to increase muscle function and contractility. We take a purpose-driven approach by leveraging our unique muscle biology expertise to engineer compounds with specific characteristics aimed at treating diseases that impact muscle function, like heart failure, ALS and SMA.
We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop the next generation of novel small molecule drugs specifically engineered to increase muscle function and contractility.
We are seeking a Corporate Counsel to join our Legal Department. This position will have the opportunity to provide legal advice and support across the company, although based on experience and prior job responsibilities will have primary responsibility to defined functional areas. This position will report to the General Counsel.
Developing a strong understanding of Company business needs to support Company's changing legal requirements and assist in designing and implementing Company policies and procedures to meet those requirements;
Strong healthcare compliance background including review and approval for disease state education, pre- and post-approval communications, reprints, sponsorships and spokespersons, advertising and promotion, labelling, conference participation, and social media, DTC and website compliance;
Drafts and negotiates regulatory terms and contracts on behalf of sponsors, applicants, application holders, and others, including clinical trial agreements, investigator-initiated study agreements, contract research organization (CRO) agreements, consulting agreements, quality agreements, safety data exchange/ pharmacovigilance agreements, and informed consent forms. Providing advice and counsel on the preparation of such agreements as well as the Company's rights and obligations under executed agreements;
Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities, including rebates, sponsorships, advisory committees, and education;
Keeping apprised of applicable federal, state, and local laws and regulations and apply them to areas of responsibility including global privacy (GDPR), FCPA and anti-bribery;
Prior experience leading the development and implementation corporate compliance program, including development and implementation of relevant policies, procedures, training and auditing and monitoring programs would be beneficial.
J.D. degree, admission to practice in California desirable
5-12 years of IP experience as in-house counsel in a biotechnology or healthcare company or a combination of in-house and nationally recognized law firm specializing in biopharmaceutical law
Preference for a candidate with both in-house and leading law firm experience
Ability to prioritize responsibilities, flexible and able to multi-task
Ability to work well with all levels of management and staff
Strong organizational skills with attention to detail
Excellent communication skills, both oral and written
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