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Clinical Project Management, Dir/Sr. Director

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.
Requirements
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.
MBA desirable
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
Integrity
Decisions & Judgment
Ownership & Initiative
Adaptability & Change Readiness
Teamwork & Collaboration
About Us
THE COMPANY
Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.
Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.
Depomed has a clear THREE PILLAR strategy for growth:
MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.
As part of the transformation strategy, Depomed has relocated its headquarters to Lake Forest, Illinois.
Depomed is an AA/EEO/Veterans/Disabled employer.



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