Associate Medical Director, Clinical Research Cardiovascular

Role Summary

Associate Medical Director, Clinical Research Cardiovascular at Cytokinetics. Provide clinical oversight to cardiovascular development programs and trial activities, including advisory board management, protocol design, site recruitment/implementation, monitoring, data interpretation, and reporting. Support and contribute to studies in heart failure and hypertrophic cardiomyopathy (HCM) from Phase I to III, and assist with future IND, Phase I-III, and NDA submissions. This is a remote role located within the United States.

Responsibilities

• Serves as a source of medical expertise for clinical project teams.
• Provides input to decisions with medical, scientific, and future marketing implications.
• Contributes medical input to design, planning, initiation, and completion of clinical trials.
• Prepares medical components of study protocols and regulatory submissions (IND and others).
• Acts as medical monitor to ensure safety and integrity of trial participants.
• Collaborates with Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, Quality Assurance, Product Development, Business Development, and Management to implement trial plans.
• Establishes relationships with leading cardiovascular clinical investigators.
• Represents the project/company at scientific meetings and external events.
• Applies regulatory strategy when interacting with agencies and key opinion leaders.
• Performs product safety medical reviews for investigational drugs.
• Maintains appropriate customer service to internal and external stakeholders.

Qualifications

• MD, MD/PhD, or DO with cardiology board certification (American Board of Internal Medicine) and either significant clinical investigator experience or a minimum of 2 years in clinical development in biotech/pharma; subspecialty training required. Experience in cardiovascular therapeutics and heart failure studies is a strong plus.
• Knowledge of CDER regulations/ICH.
• Understanding of pharmaceutical safety reporting and surveillance requirements.
• Excellent verbal and written communication and presentation skills.
• Strong interpersonal skills and leadership abilities.
• Desire to work in a multidisciplinary team.
• Computer literacy.
• Ability to work internationally.