Cytokinetics

Cytokinetics

Medical Director, Clinical Research Neuromuscular

South San Francisco, California · Director

Sponsorship not specified$276k-$322kDetected 5 days ago
ComplianceBusiness DevelopmentClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationPublic SpeakingRegulatory Affairs

About the role

  • Author protocols and investigator brochures. - Provide strategic and medical components of IND submissions, information requests, NDA submissions, pediatric investigation plans, and other regulatory interactions.
  • 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.

Responsibilities

  • Attend scientific meetings to maintain awareness of research activities and represent the Company at external events.

Requirements

  • Experience with studies in heart failure and/or heart failure subspecialty training are strong pluses.
  • Knowledge of CDER regulations/ICH guidelines.
  • Computer proficiency, including Microsoft Office.
  • Ability to travel ~20% of the time.
  • MD or MD/PhD degree with internal medicine or neurology board certification by the American Board of Internal Medicine with a minimum of 2+ years of experience in clinical development, either in a biotechnology or pharmaceutical company or as a clinical investigator, including industry-sponsored multi-center trials. Experience with studies in heart failure and/or heart failure subspecialty training are strong pluses.
  • Proven leadership experience and strong interpersonal skills, able to motivate and drive interdisciplinary teams.
  • Deep scientific, clinical and research knowledge in internal medicine or neurology.
  • Analytical and articulate in oral presentations and in writing, with a demonstrated ability to communicate effectively with colleagues at varying professional levels, especially in the medical profession.
  • Understanding of pharmaceutical safety reporting and surveillance requirements.
  • #LI-HYBRID
  • Pay Range:
  • In the U.S., the hiring pay range for fully qualified candidates is $276,120-$322,140 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.

Compensation

  • In the U.S., the hiring pay range for fully qualified candidates is $276,120-$322,140 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.

Benefits

  • In sum, the position will support future INDs, Phase I-III studies and NDA submissions and collaborate with medical affairs and commercial colleagues on launch strategy and life cycle management.
  • Serve as clinical lead, providing medical expertise for cross-functional clinical research and development teams.
  • Responsible for protocol design, medical monitoring and the clinical aspects of planning, initiation and completion of clinical trials.
  • Provide strategic and medical components of IND submissions, information requests, NDA submissions, pediatric investigation plans, and other regulatory interactions.
  • Perform product safety medical reviews for investigational drugs in collaboration with safety experts.
  • Analyze clinical trial data, author publications and present results at medical meetings.
  • Provide strategic input and medical expertise for decisions that have medical, scientific, and future marketing implications.
  • Maintain high-level scientific and medical expertise in internal medicine or neurology and serve as key medical resource in the disease area.

Equal opportunity

  • www.cytokinetics.com
  • Cytokinetics is an Equal Opportunity Employer
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This listing is sourced directly from Cytokinetics's careers page and normalized into a canonical job model.