Senior Director, Clinical Project Management

About Us

Fortvita is an emerging bio-pharmaceutical company dedicated to advancing innovative therapies that address unmet medical needs. Fortvita is passionate about groundbreaking research and cutting-edge technologies to drive development of new treatments for a wide range of diseases. With a focus on both early-phase later stage clinical trials, we are at the forefront of advancing groundbreaking therapies. We are seeking a Senior Director, Clinical Project Management to lead and oversee the execution of our clinical trials, ensuring timely and successful delivery of high-quality data.

Position Overview:

The Senior Director, Clinical Project Management will be responsible for leading and managing a portfolio of clinical trials spanning from early-phase (Phase 1/2) to Phase 3 studies. This leadership role requires a dynamic, experienced professional who will provide strategic direction, ensure the efficient execution of clinical trials, and collaborate with cross-functional teams to meet the company's clinical development objectives. The Sr. Director will oversee project teams, develop budgets, manage timelines, and ensure compliance with regulatory requirements, all while driving excellence and innovation in clinical trial management.

Key Responsibilities:

Leadership and Strategy:

• Lead the clinical project management team, providing guidance, mentorship, and fostering an environment of high performance.
• Define and execute clinical trial strategies for early-phase through Later Stage clinical programs.
• Collaborate and Guide senior leadership, medical, regulatory, and commercial teams to ensure alignment on clinical development objectives and timelines.
• Serve as the primary point of contact for internal stakeholders and external partners (CROs, vendors, etc.) on all matters related to clinical project execution.

Project Oversight:

• Oversee and manage the lifecycle of clinical trials, from protocol development through final study report.
• Ensure trials are conducted in compliance with GxP, ICH, FDA, and other regulatory guidelines.
• Monitor progress of clinical trials and proactively identify and resolve issues related to timelines, budgets, and resource allocation.

Risk Management & Problem Solving:

• Proactively identify risks associated with clinical trials and develop strategies to mitigate them.
• Lead problem-solving efforts to address issues that could impact the timely completion of studies.
• Conduct regular reviews of study progress, providing recommendations to optimize timelines and resource allocation.

Financial & Resource Management:

• Develop and manage clinical trial budgets, ensuring alignment with company goals and effective use of resources.
• Oversee the preparation of clinical trial budgets, vendor contracts, and ensure financial targets are met.

Team Development and Mentorship:

• Lead, mentor, and develop the clinical project management team, fostering professional growth and ensuring high levels of engagement and performance.
• Provide coaching on best practices for clinical trial management and project execution.

Qualifications:

Education:

• Minimum of a Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or related field (Advanced degree STRONLY preferred -MD, PharmD, PhD).

Experience:

• At least 10 years of experience in clinical project management within the pharmaceutical or biotechnology industry.
• Extensive experience managing clinical trials from early-phase through Phase 3.
• Proven leadership experience in overseeing and mentoring clinical project management teams.
• Strong experience with clinical trial budgets, timelines, and vendor management.
• Expertise in regulatory requirements (FDA, EMA, ICH) and GxP compliance.

Skills:

• Strong leadership, organizational, and communication skills.
• Exceptional problem-solving and decision-making abilities.
• Ability to manage multiple projects in a fast-paced and dynamic environment.
• Expertise with clinical trial management systems (CTMS) and other relevant software.

What We Offer:

• Competitive salary and performance-based bonuses.
• Comprehensive benefits package, including health, dental, and vision coverage.
• Opportunities for career growth and development within a cutting-edge pharmaceutical company.
• A collaborative and innovative work environment.