Director/Sr. Director, Clinical Operations 2073835

Location: Cambridge, MA (Hybrid)

Focus: Rare Disease

Job Overview: In this role, you will manage clinical operations and lead global phase 3 study start-ups, ensuring timely execution and resource optimization.

Primary Job Responsibilities: 

• Lead study start-up activities for a global phase 3 trials
• Manage external vendors to ensure protocol compliance
• Handle study monitoring, data collection, and team support
• Provide operational input on clinical development strategies
• Track timelines, enrollment, and adherence to study plans
• Identify and resolve risks or compliance issues promptly

Primary Job Requirements:

• BA/BS with 8+ years of clinical trial management, including vendor and CRO oversight.
• Required experience managing non-US clinical trials.
• Expert in late-stage drug development and study start-up leadership.
• Preferred experience in liver disease treatments, especially NASH.
• Proficient in GCP, ICH guidelines, and CFR compliance.
• Skilled in project management, communication, and adaptability.
• Experience with tools like SmartSheets is a plus.

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.

PROVEN SCIENTIFIC PLACEMENT™

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 [email protected] or 844-463-6178.