Senior Director, Clinical Operations
Janux Therapeutics
3 months ago
Remote friendly (San Diego County, CA)
United States
$250,000 - $260,000 USD yearly
Clinical Research and Development
Responsibilities:
- Provide global clinical operations strategy and execution for complex clinical programs for IND-enabling through Phase 3 and future development plans.
- Collaborate cross-functionally with senior leadership to ensure operational initiatives support company goals.
- Establish and refine scalable best practices to drive efficiency and prepare for departmental growth.
- Oversee development/review/implementation of study documents (protocols, informed consent forms, CRFs, monitoring plans, pharmacy manuals) to ensure consistency across programs.
- Manage external partner relationships (e.g., CROs, central labs, patient advocacy groups) to ensure on-time, on-budget, quality deliverables.
- Prepare and deliver program updates; establish KPIs and dashboards; present to study teams; represent Clinical Operations in internal/external meetings.
- Mentor and support direct reports; foster professional development and team culture.
- Oversee site strategy and develop relationships with investigators and key opinion leaders.
- Contribute to SOP/work instruction development and operational plans to improve efficiency and compliance.
- Develop and implement operational plans, timelines, and budgets for clinical programs.
- Ensure all trial activities comply with the protocol, SOPs, GCP, and applicable regulations.
Qualifications (Required/Preferred):
- Bachelor’s degree in life sciences or related field; 12+ years in clinical research, including 10+ years in clinical trial management. Advanced degree preferred.
- Strong oncology indication experience; cell therapy experience preferred.
- Proven track record leading complex clinical programs from start to completion.
- Knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines.
- Strong IT skills (MS Office; CTMS/eTMF/EDC).
- Expertise in clinical budgeting and resource allocation.
- Experience leading/mentoring diverse clinical teams and overseeing CROs.
- Strong communication/leadership/interpersonal skills; ability to present technical information to executive leadership.
- Strong organizational/time management; accountability, adaptability, attention to detail; able to prioritize and manage multiple tasks in a changing environment.
Benefits (as stated):
- Annual bonus program; incentive stock option plan; 401(k) with flat non-elective employer contribution.
- Medical insurance (90–100% employer-paid premiums), dental and vision.
- HSA, FSA, and supplemental insurance (life, disability, accident, critical illness, hospital indemnity).
- Unlimited PTO; generous holiday schedule (summer and winter shutdown); relocation assistance.
Application instructions:
- None provided in the text.
- Provide global clinical operations strategy and execution for complex clinical programs for IND-enabling through Phase 3 and future development plans.
- Collaborate cross-functionally with senior leadership to ensure operational initiatives support company goals.
- Establish and refine scalable best practices to drive efficiency and prepare for departmental growth.
- Oversee development/review/implementation of study documents (protocols, informed consent forms, CRFs, monitoring plans, pharmacy manuals) to ensure consistency across programs.
- Manage external partner relationships (e.g., CROs, central labs, patient advocacy groups) to ensure on-time, on-budget, quality deliverables.
- Prepare and deliver program updates; establish KPIs and dashboards; present to study teams; represent Clinical Operations in internal/external meetings.
- Mentor and support direct reports; foster professional development and team culture.
- Oversee site strategy and develop relationships with investigators and key opinion leaders.
- Contribute to SOP/work instruction development and operational plans to improve efficiency and compliance.
- Develop and implement operational plans, timelines, and budgets for clinical programs.
- Ensure all trial activities comply with the protocol, SOPs, GCP, and applicable regulations.
Qualifications (Required/Preferred):
- Bachelor’s degree in life sciences or related field; 12+ years in clinical research, including 10+ years in clinical trial management. Advanced degree preferred.
- Strong oncology indication experience; cell therapy experience preferred.
- Proven track record leading complex clinical programs from start to completion.
- Knowledge of ICH GCP, FDA regulations, and global clinical regulatory guidelines.
- Strong IT skills (MS Office; CTMS/eTMF/EDC).
- Expertise in clinical budgeting and resource allocation.
- Experience leading/mentoring diverse clinical teams and overseeing CROs.
- Strong communication/leadership/interpersonal skills; ability to present technical information to executive leadership.
- Strong organizational/time management; accountability, adaptability, attention to detail; able to prioritize and manage multiple tasks in a changing environment.
Benefits (as stated):
- Annual bonus program; incentive stock option plan; 401(k) with flat non-elective employer contribution.
- Medical insurance (90–100% employer-paid premiums), dental and vision.
- HSA, FSA, and supplemental insurance (life, disability, accident, critical illness, hospital indemnity).
- Unlimited PTO; generous holiday schedule (summer and winter shutdown); relocation assistance.
Application instructions:
- None provided in the text.