Clinical Project Management Consultant

Employer
Lilly
Location
Indiana
Salary
Competitive
Posted
April 17 2018
Ref
40535BR
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
Responsibilities
Do you desire a cross functional role to develop and execute clinical pharmacology strategy for a specific therapeutic target? Do you enjoy the opportunity to utilize your scientific and operational knowledge to lead asset strategy and integrate this into a development plan? We are seeking a dynamic individual to serve as the operational clinical integrator during the development of an asset. This role requires strong communication skills, clear demonstration of the ability to deliver results through others, reaching across boundaries to collaborate both internally and externally, and the ability to lead decisively in the midst of ambiguity.

Responsibility Include:

Scientific/Therapeutic Area Expertise
  • Leverages scientific knowledge and understanding of the business to take a lead role when working with internal and external partners to influence asset level strategy and plans.
  • Partners closely with the Clinical Pharmacologist to prepare/present asset and study details.
  • Leads operational input in preparation for governance presentations.
  • Assists project team in the preparation for meetings with Regulatory Agencies
  • Consults on and/or drafts responses to questions from Regulatory Agencies and affiliates.
  • Stays up-to-date with body of knowledge of target, disease state, competitors, and industry trends.
  • Stays up-to date with operational requirements to effectively plan Clinical Pharmacology studies and submissions.
  • Networks, builds and maintains asset level integrated development plan/clinical plan.

Clinical Project Management

Leads and has expertise in clinical project management processes and tools. These project management processes and tools include but are not limited to the development, monitor, and control of integrated clinical scope, timelines, budgets, risk management plans, and communication plans. Other specific activities in this area include:

Scope

  • Provides operational input on strategy and drives scenario evaluation for implementing asset level plans, developing realistic project milestones and deliverables, and linking the plan with the patient, payor, and prescriber needs.
  • Leads the cross-functional team in the development of the asset level plan and is accountable for the cross-functional activities supporting delivery of the entire clinical pharmacology scope of work.
  • Leads the team to develop and maintain appropriate clinical scope documentation; updates asset level integrated development plans, resources or timeline and secures team/leadership alignment.

Timeline

  • Develops and maintains up-to-date clinical plan timelines.
  • Identifies, communicates and manages the critical path and leading indicators of the team's progress to major clinical milestones.
  • Monitors and reports performance to plan and drives action when the plan is not being achieved.
  • Leads asset level clinical operations to manage key milestones/decisions including updates to schedule.
  • Ensures data completeness and accuracy within business systems.

Budget

  • Provides the team leadership an understanding of the cost of development options at asset level.
  • Partners with financial, functions, and geographies, to develop and manage the overall clinical budget for the book of work.
  • Reviews actual spend on a monthly basis to identify any potential trends and understand variances to the plan/forecast. Drives re-forecast of expenses when necessary.
  • Leads the the clinical change control process and outcomes for team/project.
  • Accountable for external vendors. This includes sourcing strategy options.

Risk

  • Leads the development of clinical plan risk assessment and mitigation/contingency planning and independently identifies and triggers implementation of such plans.
  • Communicates clinical risk assessment and mitigation/contingency plans broadly to ensure assignment of risk owners.
  • Proactively identifies risks to portfolio milestones and takes action to mitigate/avoid such risks.
  • Holds clinical risk owners accountable for monitoring and reporting status of risks; Lead implementation of mitigation/contingency plans.
Communication and Team Management
  • Influences the clinical team to document key decisions, actions and changes in scope, resources and timeline.
  • Collaborates across the clinical teams to motivate, recognize and coach team members.
  • Manages key interactions with the clinical team, including leadership in governance forums.
  • Proactively identifies critical clinical decisions, ensures technical experts are involved in decision-making, and drives decisions to resolution.
  • Effectively communicates and influences at all levels across the organization to enable decision-making.
Submission Planning and Execution
  • Leads cross-functional clinical submission operations team for Clinical Pharmacology. Acts as a point person for all clinical functional area deliverables related to the submission for Clinical Pharmacology.
  • Leads all post-submission regulatory interactions in regards to the Clinical Pharmacology package of information (e.g. regulatory responses, advisory panels, etc.).
  • Develops and owns the quality plan for Clinical Pharmacology sections of submission(s) and ensure inspection readiness.

Leadership

  • Strong collaboration with colleagues at all levels; able to work with and deliver through others.
  • Demonstrates comfort with ambiguity and effective problem-solving/solution oriented skills.
  • Demonstrates success in persuasion, influence, and negotiation skills in a matrix environment.
  • Demonstrates learning agility, strategic thinking and ability to think differently to incorporate new learning
  • Contributes to the development of others by coaching and feedback to others.

Business Acumen and Process Improvement

  • Leads asset teams by leveraging drug development expertise and process knowledge.
  • Drives the integration of cross-functional activities and understands impact of project decisions on the portfolio delivery, the business, and the patient.
  • Maintains cross-functional process expertise with Lilly policies/procedures and best practices.
  • Integrates compound strategy and study management needs with internal priorities, sound fiscal management, and the external environment.
  • Combines scientific/regulatory and operational expertise to navigate complex issues.
  • Identifies and shares learning opportunities and process improvements for conducting clinical trials

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Basic Qualifications
  • Bachelor's degree in a scientific or health related field
  • Minimum of five years clinical research or relevant experience with a strong knowledge of regulations and guidelines that apply to the conduct of clinical trials from discovery to commercialization
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences
  • Strong leadership and networking skills.
  • Ability to lead decisively in the midst of ambiguity.
  • Demonstrated ability to work effectively cross-culturally and in a virtual work environment across boundaries in order to develop strategies and plans, and deliver results through others.
  • Excellent oral and written communication skills; able to communicate clearly and with team members and leadership.
  • Strong self-management and organizational skills.
  • Strong knowledge of regulations and guidelines that apply to conduct of clinical trials.
  • Understanding of clinical drug development processes and the interdependencies of various tasks that require coordination among teams, functional groups, and regions.
  • Demonstrated knowledge and experience with project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk and procurement as defined by Project Management Body of Knowledge)
  • Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team.
  • Strong computer skills; skilled at using Word, Excel, PowerPoint, and Microsoft Project; capable of maintaining the appropriate project documentation and applying CCPM methodology
  • Experience working in the discipline of clinical pharmacology.
  • Global clinical research experience.
  • Advanced degree in scientific or health-related field

Additional Information
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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