The Director/Senior Director of Clinical Operations will oversee the planning and conduct of clinical studies, oversight of study monitoring and adverse event reporting, and coordination of clinical data management in support of clinical programs. The incumbent will contribute to clinical study design and overall project Development Plan in collaboration with the internal Project Teams, CROs, and external experts. This role will be responsible for ensuring the timely delivery and quality of study results and reports.
Essential Duties and Core Responsibilities:
Contributes to the generation of comprehensive and feasible Clinical Development Plans.
Leads all planning and execution activities in support of clinical trials including protocol synopses, full study protocols, informed consent forms, CRFs, data acquisition/management/analysis plans, protocol posting, SAE reporting, and other required documents and processes
Ensure clinical trial projects are properly resourced, managed and executed within budget, in accordance with established timelines and quality standards including inspection readiness
Represents the Clinical Operations function on Project Teams, management meetings, and external interactions (with experts, CROs, and Health Authorities). Provides input on clinical trial designs.
Ensure consistency and reconciliation of data, terms, timelines etc., across vendors, team members, within documents and communications
Ensures the establishment of Processes, Workflows and SOPs as appropriate to ensure GCP compliance according to national and international standards, (e.g. FDA, EMA, ICH).
Proactively generate and implement solutions to issues identified as trends or potential risks
Maintain communication (email, verbal, meetings, etc) with internal departments/functional team members (including vendors) as well as external corporate partners (as applicable) to ensure clear and consistent messaging is relayed to all relevant stake holders involved in our clinical trials as well as management
Oversees and directs the clinical operations activity outsourced to CROs and other vendors.
Advanced Medical/Scientific Degree (MS, PharmD, PhD) strongly preferred, with 10+ years of relevant pharmaceutical drug development experience especially in CRO management
Demonstrated excellence in complex international project management and effectively managing multiple projects/priorities is required
Solves complex problems and uses highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
Ability and interest to coordinate studies across a range of clinical indications
Must think critically, creatively and work independently
Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing across a variety of functions and teams.
Demonstrated understanding of pharmaceutical regulatory requirements (both US and abroad), ICH, GCP and impact on development of clinical trials is required.
Experience in developing RFPs (preferred), selection of investigative sites/CROs/vendors and management of external resources is required
Self-motivation, resourcefulness and the ability to work in a fast-paced team environment are essential. Intensely committed to success and getting the job done well in a highly dynamic environment
Special Request :
Travel to scientific and regulatory meetings as well as clinical vendors will be required (approximately 5-15%, depending on portfolio stage).
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