Clinical operations manager Jobs in Lowell, MA

CLINICAL TRIAL MANAGER / CLINICAL PROJECT MANAGER

Incendia Therapeutics is a precision oncology company dedicated to reprogramming the tumor microenvironment with the express intent of bringing recalcitrant cancers into submission. We recognize that cancer cells create a hostile microenvironment to privilege their own survival at the expense of the host tissue. Incendia's approach is to attack the structural and biochemical underpinnings of the tumor microenvironment to enable host immune cells and therapeutics to reach the tumor.

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 :

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 :

BENEFITS

AT INCENDIA, we strive to build a diverse and equitable workplace

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.