The Director of Project Management is responsible for the oversight and management of Healthpoint Biotherapeutics project portfolio by leading multiple project teams to achieve overall project objectives and interim milestones to support the company's strategy for long-term growth through the continuous development, regulatory approval and commercialization of products.
Summary of Essential Job Functions
Provides input into corporate strategic planning, development management processes, critical path issues/solutions, resource management, financial management and project management from conception through development cycles. Responsible for managing multiple cross-functional project teams simultaneously.
Collaborates with Project Management team and functional department representatives to assure integration of project, company, and functional goals towards achieving project milestones and timelines.
Pro-actively identifies issues that may delay product or project and recommends appropriate action(s) to be taken.
Tracks and reports on project portfolio status and health to executive management; perform and report the results of risk assessments for projects experiencing significant development issues.
Ensures projects are developed with appropriate stage-gating and milestones.
Provide periodic updates to senior management.
Provide quality control supervision of group projects and direct project quality audits and corrective actions when necessary.
Coordinate and manage the development of group budgets. Responsible for ensuring compliance with the budget.
Ensure excellent effective and efficient standards of communication across functional areas within the project and Company by using appropriate blend of meetings, networking, E-communication and formal reports for Portfolio management, ensuring the team connects with appropriate processes in a timely manner.
Sustain and further develop project and program management, scientific and leadership skills at the regional, national and international levels through attendance at relevant scientific and/or project management meetings.
Membership and good standing in appropriate project management and scientific organizations is required.
Bachelors Degree in either the Biomedical or Pharmaceutical Sciences, or one of its sub-disciplines, with 10+ years documented experience in project management and pharmaceutical product development
Or, a Masters Degree with 8+ years related experience and/or training.
Ideal candidate would have a BS degree and MBA.
Documented experience in program management.
Experience and working knowledge of regulatory pathways employed for product development, particularly in the USA, Canada, the EU and the relevant guidelines of ICH, FDA, EMEA etc., as well as GCP and GLP is required.
International awareness of current trends in clinical methodology and relevant regulatory activities is essential.
Must have effective communication skills, applied with tact and diplomacy at all times. Strong interpersonal skills and ability to deal effectively in a team environment.
Proven expertise in project management principles, practices, techniques, and tools.
Experience in leading pharmaceutical/biotechnology project teams.
Skilled in managing multiple projects and establishing priorities, milestones and stage-gating.
Effective verbal and written communication skills.
Effectively develop and mentor the Project Management team.
Ability to analyze comprehensive business processes, perform in-depth work analyses, and develop computer-generated flow charts.
Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures.
Group facilitation, mediation, and conflict resolution skills.
Skill in the use of personal computers and related software applications especially, MS Office Suite, specifically MS Project & Visio.
Ability to develop, plan, and implement short- and long-range goals.
Ability to analyze complex problems, interprets operational needs, and develops integrated, creative solutions.
Ability to develop project/program budgets and projections.
Ability to identify key performance criteria for the project execution and for the final deliverable.
Ability to apply cost accounting and financial accountability for the projects.
Ability to influence team members, peers, and senior managers in a matrix environment.
Ability to respond effectively to sensitive inquiries or complaints will be an essential function of the position. The candidate must have a track record of achievement in the pharmaceutical industry.
Healthpoint Biotherapeutics is committed to conducting business in an ethical manner and it is our expectation that the individual in this role will ensure compliance with all applicable laws, regulations, procedures and Healthpoint’s Core Values. Healthpoint is in a highly regulated industry and, as a part of this role; this individual will be required to understand how compliance is integrated within their daily activities and perform in their role with a high level of integrity.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Healthpoint Biotherapeutics, a Smith & Nephew business is an Equal Opportunity Employer.