Drug Project Manager - PGxHealth a Division of Clinical Data

Position Description

Clinical Data, Inc. (NASDAQ: CLDA), a leading provider of proprietary, pharmacogenetic tests and targeted therapeutics to improve patient care, seeks a Project Manager, CNS Drug Development, with an interest in participating in an entrepreneurial company in this new and industry-changing area. Major responsibilities will include oversight of a drug development team and overall management of the drug development process for our Phase III investigational compound vilazodone, currently in development for the treatment of depression. Vilazodone is being developed as a pharmacogenetically targeted therapeutic and is a dual-acting serotonergic compound that is both an SSRI and a 5HT1A partial agonist, with the potential for differentiation based on this MOA but also for development for other indications. This individual will be responsible for the execution and coordination of the vilazodone development plan, with NDA filing planned for 2009. Reports to Vice President, CNS.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Provides leadership for a cross-functional drug/diagnostic development team. Applicant should have experience in or direct exposure to project management, clinical and preclinical development, CMC, marketing, regulatory and other related disciplines.
• Plans, schedules and directs project activities through a cross-functional team
• Proactively identifies and mitigates risk, tracks progress and manages the team through regular team meetings and sub-team activities
• Drives project forward for earliest possible approval of the NDA and related device registration
• Ensures compliance with corporate, regulatory, and quality standard. Responsible for the submission of regulatory filings, including NDA. Coordinates document reviews and preparation of document packages. Ensures internal/external resources are appropriate to maintain quality and timeliness of submissions.
• Ensures budgets and timelines are aligned with corporate objectives
• Negotiates and supervises the activities of contract organizations and consultants as necessary
• Ensures SOPs are adequate to address needs and compliance
• Participates in conferences and scientific meetings to maintain awareness of product activities
• Participate in the evaluation of compounds for in-licensing.

SUPERVISORY RESPONSIBILITIES
Will be responsible for managing a cross functional team and building the team as needed to assure timely execution and delivery of responsibilities as outlined above. This may include direct supervisory responsibilities.

SKILL SETS AND CHARACTERISTICS
o Interest in participating in fluid, entrepreneurial business environment. Experience in both large and small companies a plus.
o Must have be self-motivated and a team player.
o Must be driven by success
o Expertise in managing drug development team.
o An understanding of pharmacogenetics and its applications a plus.


EDUCATION and/or EXPERIENCE
Experience as a project manager for cross functional teams for a Phase II/III investigational compound is necessary. Experience in psychiatry/CNS and supervision of NDA filing with an understanding and appreciation of the applications of pharmacogenetics are highly desirable; proven ability to develop and implement innovative programs and processes also advantageous. Working knowledge of electronic publishing/file management systems is an asset. Excellent written, verbal, and interpersonal skills required. Must be able to forecast timelines, resources and budgets, resolve bottlenecks and advise teams and management of impacts and changes in project timelines. Experience in the devices/diagnostics industry a plus.

How to Apply

Application Instructions / Send a Resume