Director/Advisor-Clinical Project Management

October 03 2017
Life Sciences
Position Type
Full Time
Organization Type
Job Type
As a Director/Advisor, Clinical Project Management (CPM), you are the primary point of accountability for the creation and implementation of the global clinical plan for a given molecule or portfolio of molecules. This particular role will be focused on the Early Phase Oncology and Immuno-Oncology Programs. You will work with the Medical Director and/or lead Clinical Research Physician (CRP) to ensure that the clinical plan enables both the development and commercialization strategy for the asset and ensures operational feasibility and delivery of the plan. For early phase development, you will partner with the TA Medical Director in the management of the portfolio as well as provides overall support for Therapeutic Area activities.

Clinical Planning and Execution

  • Partners with and influences the Medical Director and/or CRP, PTL to develop clinical strategies and feasible clinical plans (scope, timeline, budget and risk) that enable the development of the molecule/portfolio
  • Builds partnerships with and influences Discovery and Translational Medicine to develop robust biomarker and tailored therapy strategies
  • Facilitates phase transition/continuity for molecule(s) through collaboration with Clinical Pharmacology and Exploratory/Program Medicine
  • Owns the development of clinical team risk assessment and mitigation/contingency planning
  • Responsible for budget planning, monitoring and control of the clinical plan and re-forecasts where appropriate
  • Responsible for appropriately documenting and communicating key decisions, actions and modifications in clinical scope, resources, timeline and risk
Continuous Improvement
  • Ensures learning opportunities and process improvements are shared and implemented to streamline the effectiveness/ efficiency of conducting clinical trials and non- trial work.
  • Seeks input and works cross-functionally to determine best options
Resource Management
  • Works cross-functionally to align resources based on portfolio prioritization
  • Assesses core competencies that are required as business models evolve and address implications to overall resource management and strategies

Quality Mindset

  • Accountable for maintaining state of inspection readiness for clinical research activities
  • Models judgement based decision making to navigate compliance and quality requirements

People Management and Development

  • Recruit, develop, and retain a diverse and highly capable workforce
  • Build an organizational culture that fosters inclusion and innovation
  • Develop an organizational talent base that reflects an end to end process mindset and demonstrates judgment based decision making
Basic Qualifications
  • Bachelor Degree, preferably in a scientific or health-related field
  • Minimum of 5 years experience in the pharmaceutical industry and/or clinical research experience
  • 2 years previous supervisory experience
  • Prior experience in managing complex/cross-functional projects
  • 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
  • Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.
  • Previous experience in the management of global trials with focus on early phase development
  • A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
  • Ability to take and defend tough/unpopular positions
  • Prior project management experience and/or experience leading with multi-disciplinary team
  • Demonstrated ability to take strategic knowledge and effectively influence the direction of daily operations
  • Location in Manhattan, NY
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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