Our mission is to serve cancer patients who are the most in need of novel therapeutics. Everything we do is guided by caring for and doing the right thing for those patients. The Company’s most advanced clinical program is a clinical trial evaluating safety and potential efficacy of PRTH-101 in patients with advanced solid tumors (NCT05753722).

Visit www.incendiatx.com to learn more

LOCATION
Cambridge, MA

DESCRIPTION

Incendia Therapeutics is seeking a dynamic and experienced Clinical Trial Manager/ Clinical Project Manager to join our early-stage biotechnology company. The ideal candidate will have experience in managing clinical trials and clinical projects with a solid understanding of regulatory requirements within the biotech or pharmaceutical industry. The individual will lead and oversee clinical trial operations and should be capable of operating effectively across all functions, from pre-IND to early-stage and late-stage trials. This individual will be responsible for ensuring the successful planning, execution, and completion of clinical studies in compliance with GCP, ICH guidelines, and company policies. This role is critical to advancing our innovative pipeline and supporting our mission to provide novel therapeutics for cancer patients in need.

RESPONSIBILITIES

The Clinical Trial Manager / Clinical Project Manager will manage clinical trials and clinical projects, ensuring alignment with business goals, oversee trial progress, and coordinate with CROs and internal teams.

Here's What You'll Do:

Clinical Trial Management:

• Manage multiple aspects of our clinical development program, ensuring alignment with overall business objectives and timelines.
• Oversee the progress of clinical trials from early-stage through late-stage.
• Develop and maintain detailed project plans, including timelines, milestones, and resource allocation.
• Facilitate meetings with internal teams, external partners, and Contract Research Organizations (CROs) to track progress, resolve issues, and ensure successful project execution.

Operational Management:

• Manage relationships with CROs, ensuring high-quality performance and adherence to project timelines and budgets.
• Oversee operational aspects of clinical activities and clinical trial activities, including CRO selection and clinical study management, site selection, patient recruitment, and data management.
• Ensure site readiness and monitor site performance throughout the trial.
• Coordinate with cross-functional teams to integrate non-clinical, clinical, regulatory, data management and quality activities across all stages of development.
• Prepare and review study-related documents, including protocols, informed consent forms, and study reports.
• Prepare project updates and dashboards, articulating project progress and challenges.

REQUIREMENTS & QUALIFICATIONS

The role of Clinical Trial Manager / Clinical Project Manager at Incendia Therapeutics requires a unique blend of clinical trial and project management expertise and a deep understanding of the drug development process. The ideal candidate will have a strong background in biotech or pharmaceuticals, with proven skills in managing complex trials, projects and cross-functional teams.

Qualifications include:

• Bachelor’s degree in Life Sciences, or a related field; advanced degree preferred.
• Minimum of 6 years of project management experience in the biotech or pharmaceutical industry, with a proven track record in managing clinical and non-clinical projects.
• Strong understanding of clinical trial processes, regulatory requirements, and CRO management.
• Excellent organizational, leadership, and communication skills.
• Ability to work collaboratively in a fast-paced, dynamic environment.
• Proficiency in project management tools and software.
• Demonstrated ability to manage multiple projects simultaneously and to adapt to changing priorities.Top of Form

BENEFITS

• Competitive salary and benefits package.
• Opportunity for professional development and career advancement.
• A supportive and innovative work environment.
• Access to cutting-edge technology and research tools.