Job: Director (MD), Clinical Development

Jobing 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 selected non-clinical activities, investigational sites that are not delegated to CROs by Achillion.

Act as medical scientific support for all clinical trial efforts. Provide medical expertise and recommendations to all stages of clinical trial programs; protocol development, implementation efforts, monitoring of active studies, performs safety monitoring and ongoing data review and analysis, participates in site closeout, report generation, regulatory reporting to health authorities, and response to health authority questions.

Work with investigational site personnel, including Medical Monitors and CROs, to assure adequate Regulatory Guideline compliance. Working closely with CROs, prepare and manage EU submissions. Manage Safety Assessments and prepare final assessment for FDA submissions. Pr

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.
* Act as Medical Monitor for all clinical trials; including providing input on clinical trial protocols, determination of patient eligibility (inclusion/exclusion questions), addressing and assessing safety and efficacy issues, safety reporting, acting as medical contact.
* 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 at 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 direct oversight.
* Develop and maintain strategic relationships with third party vendors, organizations, and key opinion leaders.
* Acts as a strategic interface with other areas within Achillion

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.

Job Requirements

Core 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:

MD or related degree required

Experience:

3-7 years of relevant experience within the pharmaceutical industry