Manager, Clinical Product Development

Manager, Clinical Product Development

ICOS Corporation

Manager, Clinical Product Development

Location(s): Seattle, WA

Company Overview

ICOS is a leader in the discovery and development of breakthrough, proprietary products with high commercial potential for the treatment of serious medical diseases. The company is product-driven with a well-balanced pipeline. The company’s leading product, Cialis® (tadalifil) for the treatment of erectile dysfunction, recently received US FDA approval and is currently launched in over 50 countries worldwide.

If you are an experienced Project Manager with pharmaceutical industry experience and want to work in a fast-paced environment of a growing company, then consider ICOS.

Responsibilities

The Project Manger will be responsible for the successful delivery of project management principles to clinical study tasks and activities conducted within Clinical Affairs and will serve as the primary contact to the Clinical Team Leader for project status updates. This position will also identify critical paths, proactively perform risk assessments and coordinate risk mitigation plans to manage identified risks. This includes:

  • Lead the development of cross-functional project management plans for clinical Affairs activities, including, Gantt charts, schedules, budgets, resource plans, and risk management strategies.
  • Support Clinical Team Leader in the tracking, control and reporting of study progress against plan.
  • Communicate plans, progress and critical issues to internal and external stakeholders. Build alignment on team priorities and plans. Provide input, intervention and feedback to enhance clinical team effectiveness.
  • Coordinate the interdependencies and linkages between departments within Clinical Affairs to assure smooth study conduct and overall study objectives are achieved according to plan.
  • Work closely with Clinical Business Managers in monitoring the contractual and budgetary aspects of clinical studies.
  • Serve as the clinical team’s lead interface with Therapeutic Development and other areas of the company to assure effective integration of Clinical Affairs activities into corporate plans.
  • Generate standard metrics tracking reports that provide clear and concise summary of study status relative to plan.
  • Responsible for raising awareness regarding potential delays or unanticipated events and develop/implement contingency plans as required to proactively adjust clinical strategy where necessary.
  • Manage special projects or activities as they arise in relation to daily responsibilities, such as global contract and vendor management, assessment and implementation of new laws or regulations - worldwide, and updating and developing processes and procedures, etc.

Requirements

  • Minimum Bachelors degree (M.S, Ph.D, or M.B.A preferred).
  • 6 or more years of industry or related industry experience.
  • 2 or more years of clinical development experience.
  • Demonstrated knowledge and practical application of project management (preferably in a pharmaceutical/biotechnology company setting).
  • Strong knowledge of the drug development process.
  • Skilled in the use of project management software applications.
  • Ability to develop systems to capture and report relevant project metrics.
  • Successful track record of operating in a project management capacity within a matrix organization.
  • Demonstrated ability to perform strategic resource planning and resource allocation assessments.
  • Ability to interpret complex contracts and budgets for all phases of clinical trials.
  • Strong risk analysis and decision making ability.
  • Demonstrated skills in project planning, clinical development and implementation of strategic and tactical project management principles.
  • Excellent written and verbal communication skills.
  • Strong problem solving skills.
  • Exceptional interpersonal skills with demonstrated successful team participation.
  • Demonstrated skills in successfully managing multiple tasks simultaneously.
  • Demonstrated understanding and strong working knowledge of the clinical research and development process.
  • Highly proficient in Excel, Word and Microsoft Project.
  • Certificate in Project Management is a plus.
  • Ability to travel.

ICOS offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE

For immediate consideration visit www.icos.com and apply directly for this position or email:

Learn more about ICOS’ philosophies, attributes, financial information, and more by visiting our web site at: www.ICOS.com.

ICOS Corporation
Reference Job Code: 1609BZ0104

Email: kfenstermacher@icos.com

ICOS Corporation is an Equal Opportunity Employer