FierceBiotech and FiercePharma Jobs
Director, Clinical Development - Achillion Pharmaceuticals
Sep 15
Location: New Haven, CTCategories: All Categories
Website: http://www.achillion.com/
Position Description
Basic Function:
Responsible for clinical and non-clinical trials across various therapeutic areas. Coordinate multiple studies with CROs or manage all aspects of studies, including clinical and non-clinical investigational sites, that are not delegated to CROs by Achillion. Work with Medical Monitors, CROs, and investigational site personnel to assure adequate Regulatory Guideline compliance. Coordinate interaction between Regulatory Affairs and Clinical Development to maintain regulatory files for IND submissions, IND Annual Reports and Safety Assessments. Project management/coordination of all clinical work product, spanning preclinical development and regulatory areas.
Essential Duties:
Manage all aspects of site visits, including, but not limited to: site assessment, regulatory document collection, site initiation, patient data monitoring, drug accountability and site closeout.
Maintain contact with CROs and sites to ensure adequate regulatory compliance.
Prepare timely reports and updates for ongoing trials.
Present data/updates to peers/supervisors, and meetings outside of Achillion, as necessary.
Project Management responsibilities covering multiple and/or large-scale projects; specifically strategic planning, timeline development and setting deadlines, assignment of project related responsibilities, monitoring project status, and providing direction to lower-level Associates as needed.
Develop and maintain strategic relationships with third party vendors, organizations, and key opinion leaders.
Other Duties:
Assist in preparation of Regulatory submissions (INDs, IND Annual Reports, Safety Updates, NDAs, CTDs), Investigator Brochure updates and protocol writing.
Approximately 10%-15% travel required.
Other duties as assigned.
Competencies:
Excellent written and verbal communications skills mandatory. Ability to present study data and programs (clinical and non-clinical) to internal and external audiences as well as interface with all levels of management, negotiating and influencing to build consensus. Self-motivation, flexibility, ability to establish priorities and multi-task effectively to meet internal and external commitments. A wide degree of latitude and creativity are granted; must be able to work independently with minimal supervision. Work focused on operational plans in support of strategic goal.
Knowledge of: Basic clinical science, preferably in infectious diseases. Knowledge of infectious disease and infectious disease treatments a plus. Basic computer skills, including Microsoft Office (Word, Excel, MS Project, PowerPoint and Access). Familiar with a variety of concepts, practices and procedures related to project management.
Education: BS/MS in relevant scientific field.
Experience: 6-8 years of related experience in clinical research or related field (Regulatory Affairs, Quality Assurance, Nursing).
