Serves as a source of medical expertise for clinical project teams.
Provides input to decisions that have medical, scientific, and future marketing implications.
Provides medical input into the design, planning, initiation and completion of clinical trials.
Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions.
Serves 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.
Establishes communications and relationships with prominent clinical investigators in the area of cardiovascular disease.
Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events.
Applies the strategic intent of the Company when working with regulatory bodies such as FDA, and with key opinion leaders.
Performs product safety medical reviews for assigned investigational drugs.
Ensures an appropriate level of customer service to internal and external customers.
Requirements
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.
The is a remote role, with the requirement that the employee be located within the United States.
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Pay Range:
In the U.S., the hiring pay range for fully qualified candidates is $232,200-$270,900 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.
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Benefits
Remote work optionsEquity / stock options
Additional Information
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.
We are currently seeking a key physician to join our team and provide clinical oversight to clinical trials to our development programs in cardiovascular diseases. The position will report to the Senior Medical Director. 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.
Cytokinetics · Worldwide