Director, Clinical Operations
Xentria is a patient-centric biotech company focused on novel biologics and biosimilars. Our first program is XT MAB 16, a monoclonal antibody for sarcoidosis. XT MAB 16 has received Orphan Drug Designation and is currently in a Phase 1 study.
The Director of Clinical Operations will ensure world class clinical trial planning and execution in accordance with associated regulatory guidelines. This includes being responsible for clinical study conduct such as site selection, contract negotiations study start-up and real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Provides clinical operations leadership and oversight for all study activities (site identification and selection, enrollment models, clinical supply planning, CRO selection and negotiations, budget planning and trial execution).
- Determines operational processes, systems and standards that need to be adopted and implemented consistently to support effective clinical program management and compliance across trials and locations (e.g., SOPs, best practices, training programs).
- Supports implementation of a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies and industry best practices.
- Shares accountability for the planning process to ensure clinical studies are aligned with the overall clinical strategy and meet overall strategic goals for the company (budget, timeline and quality metrics).
- Develops and implement clinical monitoring training program to include GCP, monitoring and site management skills, and protocol-specific training (in collaboration with CMO, Clinical and Medical Monitors- internal and external vendors).
- Collaborates with legal, finance and corporate development functions to maintain continuity in planning, negotiation, forecasting and reporting metrics and milestones.
- Oversees and provides relationship management support for external vendors and clinical partners to ensure delivery of clinical objectives within established timelines and budget.
- Ensures the clinical team keeps abreast of the most effective industry practices to ensure successful delivery of clinical trials.
- Plays a lead role in the development of the clinical operations/clinical trial sourcing strategy in a start-up environment.
- Implements and oversees/mentors data management, programming and medical writing functions and ensure stage-appropriate resource allocation.
- Ensures collaborative partnerships are fostered and maintained within and beyond the clinical team; as a senior leader, act as a mentor to colleagues across the R&D organization and partner companies.
- Leads by example; provide advisory support to colleagues and foster collaborative decision-making and achievement of corporate goals.
- Communicates regularly and effectively with senior leaders across the R&D organization.
Supervisory responsibilities including 1 – 5 direct reports.
- Team Work
- Project Management
- Deep understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical operations; including understanding of clinical research principles, drug development process, FDA & ICH, GCP, GCDMP and related regulatory requirements & guidelines.
- Clinical experience in all phases of clinical development including IND filings and registration experience is a plus.
- Experience with rare disease trials and programs leading to accelerated approval is highly desired.
- Proven experience in CRO/vendor selection, contracting, oversight and relationship management.
- Demonstrated excellence in global clinical program/trial management including complex project management and effective management of multiple projects/priorities and budgets.
Education and/or Experience Required
- Bachelor’s degree in health sciences or related field; Masters or PhD preferred.
- Minimum 5 years’ experience in biotech or pharma environment; strong oncology therapeutic experience required.
Microsoft Word, Excel, PowerPoint and Project
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.
This is a remote position.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled