Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

The position will report to the Chief Medical Officer. This role will be chartered to provide medical guidance to all aspects of product development including clinical advisory board management, protocol design, clinical trial site recruitment/implementation and monitoring; as well as data interpretation and reporting. He/she will also support and play a pivotal role in supporting studies in heart failure and HCM from Phase I to III. The position is also expected to support future IND, Phase I-III and NDA submissions.

Responsibilities

• Serve as a source of medical expertise for clinical project teams
• Provide input to decisions that have medical, scientific, and future marketing implications
• Provide medical input into the design, planning, initiation and completion of clinical trials
• Manage the preparation of the medical components of study protocols and IND and other regulatory submissions
• Serve as the medical monitor for the successful conduct, integrity, and safety of patients in our clinical trials
• Partner with Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, Quality Assurance, Product Development, Business Development, and Management to formulate and implement comprehensive clinical trial plans
• Establish communications and relationships with prominent clinical investigators in the area of cardiovascular disease
• Attend appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events
• Apply the strategic intent of the Company when working with regulatory bodies such as FDA, and with key opinion leaders
• Perform product safety medical reviews for assigned investigational drugs
• Ensure an appropriate level of customer service to internal and external customers

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.

Qualifications

• MD, MD/PhD, or DO degree with cardiology board certification by the American Board of Internal Medicine with either significant clinical investigator experience with 4 years in clinical development in a biotechnology or pharmaceutical company or related experience
• Sub-specialty training and prior industry experience in the clinical development of cardiovascular therapeutics is required; experience with studies in heart failure is a strong plus
• Knowledge of CDER regulations/ICH
• Understanding of pharmaceutical safety reporting and surveillance requirements
• Excellent verbal and written communication skills and presentation skills
• Strong interpersonal skills
• Leadership skills
• Desire to work within a multidisciplinary team
• Computer literacy
• Ability to work internationally

Salary pay range: $234,000 - $286,000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled. 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.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer