Job Title: Senior Manager/Associate Director, Clinical Operations

Job Description

We are seeking an experienced Associate Director of Clinical Operations to join our dynamic team. The ideal candidate will have extensive experience in clinical trial management within small biotech or pharmaceutical companies, with a strong background in oncology. This role requires hands-on trial management and oversight of CROs, with a focus on solid tumor and hematology programs.

Responsibilities

• Manage and oversee clinical trials with a focus on oncology and hematology.
• Provide oversight and management of two CROs.
• Ensure good clinical documentation practices, including ICFs, CRFs, and adherence to GCP-ICH guidelines.
• Support patient recruitment efforts within the solid tumor program.
• Collaborate with internal teams, including Senior Clinical Operations, Senior Director of Clinical Operations, and Clinical Trial Associates.
• Contribute to building and expanding the clinical operations team.

Essential Skills

• 5 years of experience in clinical trial management at a CRO or pharmaceutical/biotech company.
• Experience in oncology, preferably with solid tumors or hematology.
• Strong clinical documentation skills, including ICFs, CRFs, and GCP-ICH.
• Experience managing and overseeing CROs.
• Hands-on trial management experience.
• Small biotech or pharmaceutical experience.

Additional Skills & Qualifications

• 4-7 years of trial management experience.
• At least 2 years of experience from a sponsor company.
• Early-stage clinical trial experience is preferred.
• Global experience is a plus but not required.
• Experience with cell therapy is a plus.

Work Environment

This is a highly social company that values team building and employee engagement. The company has been recognized as a top place to work by the Boston Globe for the past two years. Employees enjoy free lunch on Tuesdays and Wednesdays in the office. The team is flexible with office days and has a collaborative setup involving Senior Clinical Operations, Senior Director of Clinical Operations, and Associate Director of Clinical Operations. The company is currently focused on solid tumor and hematology programs and recently dosed their first patient in May. The environment is supportive, with a focus on building out the team and bringing more operations in-house.

Pay and Benefits

The pay range for this position is $140000.00 - $180000.00/yr.

PTO, Stock, medical dental vision 401k

Workplace Type

This is a hybrid position in Waltham,MA.

Application Deadline

This position is anticipated to close on Apr 11, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $140,000 - $180,000