Senior Director Clinical Development

SENIOR DIRECTOR – CLINICAL DEVELOPMENT (CARDIOVASCULAR)

A leading biotech company with a strong presence in the U.S. and Europe has been dedicated to pioneering innovative treatments for serious diseases for over three decades. With a well-established platform in RNA-based therapies, the company continues to push the boundaries of drug discovery, delivering breakthrough medicines to patients with high unmet medical needs. Having successfully brought multiple therapies to market and with an expanding late-stage pipeline, the organization remains committed to scientific excellence and innovation. Employees benefit from a dynamic and collaborative work environment, where their expertise is valued, and career growth is encouraged.

The company is seeking a seasoned clinical development leader to drive multiple programs within the cardiovascular therapeutic area. This role will be responsible for shaping and executing clinical development strategies, ensuring the design and successful implementation of trials, and contributing to regulatory and scientific communications. The position requires strategic vision, hands-on leadership, and the ability to collaborate across functions.

Key Responsibilities

• Lead the development of clinical strategies and trial designs, ensuring alignment with company objectives.
• Serve as a key representative in both internal and external engagements, advocating for program success.
• Act as a Medical Monitor for company-sponsored trials (if holding relevant qualifications).
• Collaborate with regulatory agencies and internal regulatory teams to develop innovative and efficient clinical programs.
• Guide the creation of essential clinical study documents, including protocols, investigator brochures, and regulatory submissions.
• Build and maintain strong relationships with medical experts, investigators, and advisory boards to optimize drug development strategies.
• Oversee cross-functional project teams, facilitating effective meetings, tracking progress, and ensuring timely decision-making.
• Identify and mitigate potential risks to clinical programs.
• Manage and develop direct reports, fostering a culture of scientific excellence and innovation.
• Oversee project budgets in coordination with project management and finance teams.
• Support clinical trial execution by engaging with investigators, providing scientific presentations, and ensuring high-quality data collection.
• Mentor and educate internal teams on clinical and scientific aspects relevant to the programs.
• Contribute to scientific publications and conference presentations.
• Stay updated on advancements in cardiovascular medicine and related fields, integrating emerging data into program strategies.
  
  

Qualifications & Experience

• MD and/or PhD with significant leadership experience in clinical development within the biopharmaceutical industry.
• Strong expertise in cardiovascular diseases, with a preference for candidates experienced in heart failure drug development.
• Proven track record in designing and executing clinical trials, particularly in early to mid-stage development, with phase 3 experience considered an advantage.
• Demonstrated ability to drive strategic decision-making and lead teams in a collaborative environment.
• Excellent interpersonal and communication skills, with an ability to build strong internal and external relationships.
• A hands-on, solution-oriented approach to clinical development, balancing strategic planning with operational execution.
• Proficiency in analyzing complex scientific and regulatory challenges and translating them into actionable plans.
• Ability to thrive in a fast-paced and evolving environment while maintaining high standards of quality and efficiency.