Sr. Director Clinical Operations/Program Lead

Apex Systems; Watertown (MA); Hybrid; USD 150,000 - 200,000; Full time

Job summary

A leading company in the biotech sector is seeking a Sr. Director of Clinical Operations. You will oversee clinical trials for high-priority immunology programs, focusing on strategic execution and regulatory compliance. The position demands an experienced leader proficient in clinical operations and team management, thriving in adaptable environments.

Qualifications

• 10+ years in clinical operations in pharma or biotech.
• Experience in leading high-performing teams.
• Deep knowledge of global regulatory requirements.

Responsibilities

• Lead clinical trial execution, ensuring timelines and quality.
• Develop and manage trial plans with protocols and budgets.
• Collaborate cross-functionally on objectives and milestones.

Skills

Leadership

Regulatory Compliance

Problem Solving

Adaptability

Education

Degree in a health-related field

Advanced degree in life sciences or nursing

Job description

Sr. Director Clinical Operations/Program Lead 2074235

Location: Watertown, MA (Hybrid)

Focus: Immunology/Inflammation

Job Overview: In this role, you will lead and oversee all aspects of clinical operations for a high-priority immunology program, ensuring strategic trial execution, regulatory compliance, and cross-functional collaboration to drive successful outcomes.

Primary Job Responsibilities:

1. Lead clinical trial execution, ensuring timelines, budgets, and quality standards.
2. Develop and manage trial plans, including protocols, budgets, and risk strategies.
3. Collaborate cross-functionally, aligning teams on objectives and milestones.
4. Oversee CROs and vendors, ensuring contract adherence and performance.
5. Ensure regulatory compliance.

Primary Job Requirements:

• Degree in a health-related field, with preference for an advanced degree in life sciences or nursing.
• 10+ years in clinical operations, with expertise in pharma or biotech industries.
• Proven leadership experience, building and managing high-performing teams.
• Deep knowledge of global regulatory requirements, including US CRF, EU CTD, and ICH GCP.
• Strong adaptability and problem-solving skills, thriving in fast-paced environments.