Senior Director, Clinical Operations - Early Phase Oncology 1145460
Job Scope & Purpose:
Our client is a growing, oncology-focused company offering all phases of development and an exceptional culture. They seek a talented Sr. Director, Clinical Operations to primarily focus on early stage development including the direction, planning, execution, and interpretation of clinical trials under Good Clinical Practices. The Sr. Director of Clinical Operations will assist in the development and implementation of strategy, policies, and procedures as well as manage other members of the clinical operations team and some aspects of external vendor contracts including CRO.
Primary Job Responsibilities:
- Establish clinical development plans and report generation to track progress in meeting key program and corporate milestones.
- Interact with Clinical Development, program management, and other key functional groups about issues affecting clinical programs including timelines, budget and communications of data.
- Work with internal and external stakeholders to ensure completeness, accuracy and validity of data.
- Assist Associate Directors and clinical trial managers in the planning, designing and managing progress of clinical projects.
- Responsible for the management of the clinical operations team including, but not limited to hiring, and developing, training; contribute to management of clinical team to ensure a high level of performance.
- Assist Vice President (VP) with Clinical Trial planning, SOPs, templates, forms and systems for contracts, budgets and clinical trial agreements, etc.
- Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
- In conjunction with legal group and Clinical Contracts manager, assist with the development of clinical trial agreements and other relevant documents.
- Work with VP to manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.
- Responsible for creation and management of program-level budget(s) with Program Lead.
- Participate in contract and budget negotiations with CROs, clinical sites and vendors.
- Work cross-functionally to ensure clinical program timelines and goals are met.
- Provide study-specific mentoring and line management for junior team members, as appropriate.
- Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc.).
Primary Job Requirements:
- Bachelor’s degree in health sciences or related field
- Minimum 10+ years of clinical operations and 8+ years management experience in an industry setting
- Experience in Oncology required, and experience with data management will be favorably considered
- Comprehensive knowledge of clinical development processes with a requirement for early stage development experience, policies, and regulations with international studies
- Extensive CRO/vendor management experience required
- Strong leadership and management experience including employee development and team building
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.
[ Email address blocked ] - Click here to apply to Senior Director, Clinical Operations - Early Phase Oncology
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
Coaching And Mentoring