At DiCE Molecules, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
Sr. Director, Clinical Operations
MAIN PURPOSE OF POSITION:
This position will lead clinical trial team(s) and oversee the management of all operational aspects of clinical study conduct from selection and qualification of full service vendors and investigational sites through finalization of clinical study reports and regulatory filings.
MAIN DUTIES AND RESPONSIBILITIES:
- Develops and leads operational strategy for implementation, execution, oversight, monitoring, and completion of Phase I and II clinical trials within designated program budgets and timelines
- Responsible for all operational aspects and progress of clinical trial from study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicators while ensuring that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct
- Develops country and site selection strategy and enrollment forecast and implements patient recruitment/retention strategies
- Develops RFPs, select CROs/vendors, and oversees vendor operational activities
- Responsible for selection and study specific training of CRO study staff, monitors, investigational sites, and vendors
- Responsible for oversight and management of sites including review of ICFs, IRB and EC committee responses, vendor budget activities, investigator payments, clinical trial agreements, etc.
- Participates in the development/review of SOPs, Protocols, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, and safety documents
- Provides operational and strategic input and ensures timely preparation of study-related documents including protocols, CRFs, CRF Guidelines, vendor specific guidelines, charters, SAE forms and processes, Data Management plans, IVRS specifications, investigator meetings, monitoring plans, and CRA training
- Provides oversight for quality assurance and monitor for compliance to GCP and relevant regulations
- Review CRO SOPs for GCP regulatory compliance and ensure their use and implementation
- Contributes to defining priorities and activities critical to company success within functional area.
- Leads departmental strategic initiatives
- Must have a science/nursing background, advanced degree preferred.
- A minimum of 10-15 years of related pharmaceutical experience with the 7+ years as a Project/Clinical Operations Manager or Leader.
- Line management experience required.
- Prior involvement with leading the operations of Phase I and global Phase II and/or III trials are required
- Experience with immunology clinical trials preferred
- Possess an entrepreneurial spirit and adaptable to a dynamic environment, with strong leadership and interpersonal skills
- The individual should be bright, self-motivated, articulate and creative, as well as collaborative and analytical
- Strong technical judgment with attention to detail and proactively manages and identifies potential issues/risks and recommends/implemensts solutions with key internal and external stakeholders
- Must be highly computer literate and should be familiar with standard project planning tools
- Working knowledge of ICH, GCP, and FDA guidelines and regulations is required
- Strong oral and written communication skills
- Ability to set goals, build accountability and to follow-through
- Promotes positive work environment and sets highest standards for business ethics and integrity
- Ability to multi-task, manages timelines, and adapt to rapid change
- 10-20% Travel required
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.