Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities include, but are not limited to, the following:
This position is responsible for assisting in leading the development and execution of investigational material supply strategies for Celgene sponsored early and late stage development programs intended for regulatory approvals of new products and for new indication or line extensions of currently approved products. Working as a key member of the Strategic Program Management Team, the incumbent will proactively recognize and address any technical and regulatory issues associated with the ability to meet the requirements of the clinical development program and Project Team objectives. The incumbent will also be considered a subject matter expert on all information regarding the global use of investigational material in clinical studies.
- Lead Program Level Planning (PLP) teams to develop integrated cross functional strategy and implementation plans to ensure a continuous supply of investigational product as outlined by Project Team strategies and objectives.
- Work with the Senior Strategic Program Director to obtain approval of strategy and implementation plans from appropriate governing bodies i.e. ( IMSC Senior Management Team, Project Team) .
- Accountable for timely, cost effective and high quality execution of approved strategies.
- Manage project budget and project timelines, with the support of IMSC management and functional leadership, ensuring appropriate and timely resource allocation to achieve project goals and deadlines.
- Assigned to multiple complex projects.
- Recognizes potential problems as they arise.
- Raises appropriate issues to Sr. Mgmt as needed.
- Manages and coaches assigned program managers.
- Provide, and continuously update, a balanced appraisal of the project status, including risk, cost, and value to stakeholders ( Project Team, Study Teams, Pharmaceutical Development). Develop corrective action plans if deviations occur.
- Foster strong collaboration with all functional partners, including Clinical Operations, to assure clinical trials are conducted efficiently and effectively Solve abstract problems across functional areas of the business.
- Identify and evaluate fundamental issues for major functional areas through assessment of intangible variables.
- Responsible for alignment of functional execution plans with approved supply strategies.
Primary interface with governing bodies and responsible for communicating and implementing governance body decisions.
Ensure alignment between the project strategy and tactical execution of the supply plans
Assure coherence between the global supply strategy, Project Team objectives and IMSC line management objectives.
- Ensure that all PLP team members understand project goals and objectives, current supply strategies and schedule, critical path activities and activities that may become critical path activities
- Provide input to the development of corporate goals and additional activities outside of primary scope of work (e.g. strategy development, clinical program assumptions, regulatory strategies)
- Leads Development of PM best practices
- Provide overall project leadership to the PLP Teams
- Articulates a clear, compelling vision and direction for the team, linking it to the Celgene mission
- Clarifies team member roles and responsibilities, sets clear expectations holding team members accountable for meeting commitments and timelines
- Creates a supportive environment of open communication and actively engages and listens to others viewpoints
- Identifies and manages conflict resolution quickly and constructively
- Establishes a clear framework for decision making so that team members are empowered and informed about the types of decisions made at the team level and at the governance/executive level
- Escalate issues in a timely fashion.
- 12+ yrs experience in the pharmaceutical industry with >7 yrs experience in drug development, clinical supply chain management and/or clinical manufacturing and 3+ years in project management
- Experience in multiple functional areas (clinical, regulatory, quality) demonstrating a broad understanding of pharmaceutical development.
- Advanced knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
- Experience with planning and execution of investigational materials supply strategies
- Demonstrated strategic and leadership skills
- Expert knowledge of PM best practices
- Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
- Result oriented individual to execute strategy and meet objectives
- Experience managing change in a dynamic, complex environment
- Strong background in cGxPs and ICH requirements.
- Excellent Cross-functional negotiating skills
- Coaches team members
- Influences key stakeholders outside of the team
- Broad internal network, developing external network
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.