Project Manager

This position is responsible for managing the outsourcing of clinical trials and coordinating internal GMP manufacturing campaigns. Plans and coordinates internal project activities to include developing and managing budgets, constructing timelines, and developing productive relationships with internal and external customers. Initiates and coordinates the decision-making process. Trouble shoots and is proactive in dealing with vendor issues. Position is minimally supervised. Must be a self-starter, results oriented and highly motivated.

Requirements include:

Requires a B.S. degree in a scientific discipline plus 5 years or an M.S. in scientific discipline plus 2 years of experience in managing clinical trials and/or GMP manufacturing, in the drug development / pharmaceutical / biotechnology industry. In addition, incumbent must demonstrate previous experience and possess the following:

· Must have experience developing and administering timelines; and ability to manage budgeting processes.

· Possesses a comprehensive understanding of the clinical trial process and regulatory requirements.

· In depth knowledge of the drug development process within the pharmaceutical industry.

· Strong negotiation skills and ability to effectively troubleshoot problems as necessary.

· Ability to interface effectively with all levels of management, both internally and externally.

· Ability to leverage and maximize company-wide resources.

· Requires excellent communication and presentation skills.

· Strong leadership skills including meeting facilitation cross-functional team integration, strategic thinking and coaching.

Responsibilities Include:

· Coordinate with legal to ensure proper and timely establishment of CDAs, MSAs, and contracts with Contract Research Organizations, clinical sites and analytical testing labs

· Coordinate in-house clinical trial material GMP manufacturing campaigns

· Establish, negotiate and maintain clinical study budgets and administer milestone payments

· Track clinical studies activities and timelines (screening, enrollment, dosing) and resolve issues with the clinical sites

· Manage project deliverables such as data, analytical reports and clinical study reports using MS Project to ensure these are met within the specified timeframes

· Identify vendors for clinical trials and analytical testing labs and coordinate the vendor qualification process with QA

· Facilitates information flow between CROs, Project Management, Clinical Logistics, and other internal departments.

· Interact with Vendors to maximize efficiencies and cost savings and resolve Vendor/Sponsor conflicts.

· Ensure financial obligations as defined in contracts are met

· Organize team meetings, author meeting minutes and track action items

· Establish, manage and track project timelines both internally and externally

· Ensure financial obligations as defined in contracts are met

· Requires the ability to gain cooperation of others and effective facilitation of cross-functional meetings/discussions.

· Communicates effectively and interfaces with all levels of management.

· Erroneous decisions will have a long-term effect on Company success.

We offer competitive compensation and benefits package, including opportunity to participate in the success of the company through employee stock option programs.  

Please forward your resume in confidence to:

Human Resources Department: HH

Email: jobs@emisphere.com

Fax: (914) 593-8166

Emisphere Technologies, Inc.

765 Old Saw Mill River Road

Tarrytown, New York 10591

www.emisphere.com