Sr. Director Clinical Operations/Program Lead

Apex Systems; Massachusetts; Hybrid; USD 140,000 - 180,000; Full time

Job summary

Apex Systems seeks a Sr. Director of Clinical Operations to oversee a high-priority immunology program in Watertown, MA. The role demands strong leadership, regulatory compliance oversight, and cross-functional collaboration to ensure successful clinical trial execution. Ideal candidates will bring over 10 years of experience in clinical operations, preferably within the pharma or biotech sectors, and possess an advanced degree in a health-related field.

Benefits

Medical, dental, and vision insurance

401K program with company match

Employee stock purchase program

Flexible spending account options

Employee assistance program

Professional development opportunities

Qualifications

• 10+ years in clinical operations with expertise in pharma or biotech.
• Proven leadership experience in managing high-performing teams.
• Deep knowledge of global regulatory requirements including CRF, CTD, and GCP.

Responsibilities

• Lead clinical trial execution ensuring timelines, budgets, and quality.
• Develop and manage trial plans including protocols and budgets.
• Collaborate across teams to align on objectives.

Skills

Leadership

Problem-solving

Adaptability

Education

Degree in health-related field

Advanced degree in life sciences or nursing

Tools

Regulatory compliance knowledge

Job description

Sr. Director Clinical Operations/Program Lead

Sr. Director Clinical Operations/Program Lead 2074235

Location: Watertown, MA (Hybrid)

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:

• Lead clinical trial execution, ensuring timelines, budgets, and quality standards.
• Develop and manage trial plans, including protocols, budgets, and risk strategies.
• Collaborate cross-functionally, aligning teams on objectives and milestones.
• Oversee CROs and vendors, ensuring contract adherence and performance.
• 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.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [e-mail] or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Apex Benefits Overview:Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.