Sr. Manager - Associate Director, Project Management
Remote , 20th Floor Remote, TN 37203 US
The Associate Director, Program and Project Management (Drug Development) provides project management leadership to drug development projects, including project teams, sub-teams, submission teams, and collaboration partner teams. The individual will work closely with Senior Director of Program and Project Management, Project Team Leader(s), functional team members, and critical functional leaders to ensure successful completion of project goals on schedule and within budget. This individual is responsible for the initiation, planning, execution, control and close out of cross-functional projects the integration between different areas, including CMC, clinical development, commercial, medical affairs, preclinical, and regulatory affairs. This individual will also participate in project management and process improvement initiatives as required.
Essential Duties/ Responsibilities
- In collaboration with the assigned project leader, manage and operationally lead cross-functional drug development project teams and subteams as assigned.
- Drive all aspects of the product and project management process, to ensure smooth and effective functioning of the product development teams; including defining and managing team member roles, responsibilities, conflict management and communication for the teams.
- Establishment of development plans and timelines including non-clinical, manufacturing, clinical development, regulatory, and quality management directed toward regulatory approval.
- Drive timeliness and influence decision making process without direct authority.
- Prepare and routinely review project plans with team members on a regular basis to update, provide reminders, identify critical path items, develop action plans to solve critical issues, and elevate specific concerns to senior management.
- Coordinate the cross-functional decision-making process and facilitate information flow between team members, the project leader, senior management and corporate collaborators.
- Identify program-related risks and work with teams to develop mitigation plans.
- Guide and support team leaders in prioritizing, troubleshooting and contingency planning.
- Proven ability to prioritize, plan ahead, and manage a high volume of work to meet deadlines and ensure that the operation runs in an efficient and timely manner.
- Ability to balance risk and pragmatism when developing solutions while always working with the highest level of professionalism, both individually and as part of a team.
- Communicate project status and progress to senior management, team members, and functional heads using appropriate tools.
- Use solid understanding of business and science to help establish priorities for company and identify risks associated with various strategies.
- Develop and implement improvements to project management processes, tools and infrastructure to ensure ongoing efficiency across the company.
- Minimum 10 years of project management experience with multidisciplinary development teams in the biotech or pharmaceutical industry
- Experience with biologics product development preferred
- Experience in clinical product development activities and associated regulatory filings (INDs, IND Amendments, BLAs)
- B.S. in a Life Science or Pharmaceutical Science required
- M.B.A. or other advanced degree preferred
- PMP certification preferred
- Strong interpersonal skills and the ability to influence without authority
- Strong knowledge of scientific principles and concepts
- Strong leadership and management skills
- Strong written and verbal communication skills
- Intermediate skill level with Word, Excel, Project and PowerPoint or equivalent required
- Operational Excellence / Continuous Improvement Training Management
*CO candidates may not be considered
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