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Cytokinetics logo
Cytokinetics

Empowering Muscle Empowering Lives

Associate Medical Director, Clinical Research, Cardiovascular

Medical DirectorMedical DirectorOtherRemoteLeadTeam 201-500Since 1998H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

156 days ago

Salary

$232.2K - $270.9K / year

Seniority

Lead

Postgraduate Degree2 yrs expEnglish

Job Description

Associate Medical Director, Clinical Research, Cardiovascular

Cytokinetics

• 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

Job Requirements

  • MD, MD/PhD, or DO degree with cardiology board certification by the American Board of Internal Medicine
  • Significant clinical investigator experience or a minimum of 2 years in clinical development experience in a biotechnology or pharmaceutical company
  • Sub-specialty training is required
  • Industry experience in the clinical development of cardiovascular therapeutics and 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

Benefits

  • Health insurance
  • Flexible working arrangements
  • Professional development opportunities

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