VP/Sr. Director Clinical Operations - Immuno-Oncology
Director/ Senior Director/ Vice President Clinical Operations I/O 1332800
Location: Cambridge, MA (Hybrid)
Science/ Focus: Immuno-oncology
Therapeutic Area: Immuno-oncology
Job Overview: Strong clinical operations professional with experience in early phase immune-oncology to set up infrastructure and build clinical operations function.
Responsibilities:
- Direct and run clinical operations and clinical trial launch activities for clinical programs
- Manage clinical research organizations, clinical and testing lab vendors
- Establish clinical operations infrastructure across the organization
- Maintain relationships with Sites and KOLs
- Oversee all key study delivery functions
Qualifications:
- Bachelor of Science required, Masters of Science preferred. Degree in nursing, life sciences or a related discipline preferred.
- 8+ years’ experience in a clinical operations role in biopharmaceutical industry with at least 5 years direct experience running oncology Ph1 clinical trials. Experience with Ph 1-3 immuno-oncology clinical trials preferred.
- 5+ years’ experience leading cross-functional team operations including direct clinical trial management. Previous study start-up and clinical monitoring experience desired.
- 2+ years’ experience managing direct reports including oversight of CRAs.
- Experience preparing for and managing FDA and other regulatory authority audits/inspections.
- Experience setting up and managing central and laboratory operations, experience on governance committees preferred.
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.
Code: ClinOps
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 employeeservices@apexsystems.com or 844-463-6178.