Sr. Director, Clinical Operations - Ph III 2070439

Location: Cambridge, MA (Hybrid)

Science/ Focus: Various

Job Overview: This role will spearhead global Phase 3 study executions, oversee CRO and vendor management, guide study monitoring and strategic development, ensure compliance with study plans, manage budgets, and mitigate potential risks.

Primary Job Responsibilities:

• Leads Phase 3 study operations focusing on start-up activities globally.
• Manages CROs and vendors, ensuring compliance with company protocols.
• Independently oversees study monitoring, data collection, and team support.
• Leads in clinical strategy discussions and assesses strategy feasibility.
• Ensures adherence to development plans by CROs and internal teams.
• Manages study timelines, enrollment goals, and project tracking.
• Creates and contributes to study documents like contracts and protocols.
• Manages study budgets and proactively addresses compliance and risk issues.

Primary Job Requirements:

• BA/BS degree and over 10 years in clinical trial management, including supervising staff and CROs.
• Required experience managing Ex-US trials.
• Experienced in late-stage drug development and study start-ups.
• Background in hepatology
• Understands GCP, ICH, and relevant CFRs well.
• Strong project management, communication skills, and adaptability.
• Proficient in time management and experienced in cross-functional collaboration.
• Resourceful, creative, committed to confidentiality and teamwork, and aligns with company values.

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.