Role Overview The Senior Director, Clinical Operations is responsible for directing the strategy, management, and oversight of clinical program(s) and functional activities as assigned.
Key Responsibilities - Acts as Clinical Operations program lead for assigned program(s)
- Represent Clinical Operations at the Clinical Development Team and/or Global Program Team
- Develops and executes program operational strategy
- Partners closely and effectively with other functions and functional heads to drive program forward
- Provides strategic and technical recommendations to senior leadership
- Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors)
- Acts as an escalation point for CRO/vendor issues
- Directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments
- Partners with CRO and other vendors to deliver on study execution
- Creates and tracks clinical program budgets
- Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors
- Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports, etc.)
- Builds relationships with clinical sites, vendors, and key stakeholders
- Maintains understanding of external landscape and adjusts plans accordingly
- Represents Clinical Operations in cross-functional activities as assigned
- Plays a key role in the development and management of the Clinical Operations function; may act as a deputy for the Head of Clinical Operations as assigned
- Hires, manages, coaches, and mentors staff
- Contributes to building the organization
Qualifications - Bachelor's degree in a related field required, an advanced degree is a plus
- 17+ years of clinical research experience, including 10+ years of trial and/or program-level management within a biopharmaceutical company, and 3+ years of line management experience
- Exceptional clinical trial & program management skills with a focus on strategic oversight of program execution on time and on budget
- Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc)
- Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
- Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development
- Experience managing, coaching, and mentoring personnel
- Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration
- Able to drive decisions forward in times of ambiguity or with incomplete information
- Effective in promoting and maintaining productive internal and external relationships
- Proven leadership and team building skills, along with success in proactive risk mitigation and problem solving
- Flexible and creative to meet the needs and challenges of a growing, dynamic company
- Demonstrated problem solving abilities
- Proven ability to influence up, down, and across the organization
- Strong financial acumen with outstanding track record of building budgets and managing expenses to budget
- Study coordinator and/or site monitoring experience a plus
- Thrives in a small company environment, where day-to-day duties go above and beyond this job description
- May contribute to corporate activities, e.g. preparation for Board of Director meetings
Position Location This is a remote role; periodic travel to team and company events is required.
The anticipated salary range for candidates for this role is $255,000 - $280,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
