Clinical Project Management, Dir/Sr. Director
Description Reporting to the Chief Medical & Scientific Officer this will be a highly visible position responsible for the management of activities across functions to ensure successful delivery of projects in line with corporate goals, milestones and within budget across a diverse portfolio of assets. ESSENTIAL JOB FUNCTIONS Essential Duties and Job Functions:
Develop project plans with established goals, milestones, timelines, and budget for clinical/medical and regulatory activities. Activities range from management of activities related to clinical development (e.g. protocols, clinical trials, investigator brochures), CRO budgets/oversight, regulatory submissions (sNDA, NDA, briefing documents), medical affairs, pharmacovigilance
Serve as the point-person for the Chief Medical & Scientific Officer and his reports for the status and delivery of clinical/medical and regulatory projects
Partner with function heads, external partners, and the project team to ensure project is on track and aligned with corporate goals.
Closely monitor and track project schedules toward milestones and issue status reports.
Anticipate, identify, and resolve discrepancies in project priorities, plans, and activities.
Develop and track project budgets, identify variances, anticipate scope changes, and communicate changes and issues that may impact the current project budget.
Partner with project team leaders to ensure that the development functions perform optimally within the framework of a specific project.
Directs highly complex project communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status.
Schedules, coordinates preparation for Leadership Team meetings
Facilitates goal-setting ensuring alignment with company goals.
Due Diligence - participates in managing the functional review/assessment of potential opportunities, provides integration and project management support post-acquisition.
Prepare and present periodic updates at appropriate committee meetings.
Partner with partner alliance managers to support and promote communication between companies;
Address complex problems in which analysis of situations requires an evaluation of intangible variables.
EDUCATION AND EXPERIENCE
Degree in life sciences, chemistry, business administration, or finance, with 8+ years successful project management track record in the biopharmaceutical /pharmaceutical industry.
Experience in project management related to clinical trials, regulatory submission efforts with consistent track record of successful project delivery
Knowledge of drug development functional areas, including preclinical, clinical, regulatory affairs
Excellent communication and inter-personal skills
Expertise in preparing project plans and project/program presentations and updates
DEPOMED COMPETENCIES INCLUDE
Decisions & Judgment
Ownership & Initiative
Adaptability & Change Readiness
Teamwork & Collaboration