Associate Director, Therapeutic Area Project Management
Company Name:
Regeneron
Job Summary and
Essential Functions:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Associate Director, Therapeutic Area Project Management
Summary: Develops, drives, and directs operational plans for conducting clinical research, producing publications, and regulatory submission documents. Provides project management leadership and oversees/manages the planning, design, implementation, and completion of clinical research activities and regulatory correspondence.
Responsibilities: The Project Manager (PM) is the key partner to the Therapeutic Area (TA) Head. The TA Head is the Clinical and Scientific lead for the deliverables of the therapeutic area. The PM is the operational lead and dotted-line reports to the TA Head.
The PMs key deliverables are:
Clinical and Regulatory project schedules & budgets, critical path analyses, and risk assessment and management across the therapeutic area
Assurance of timely and high quality production of TA clinical and regulatory deliverables to internal and external customers and external regulatory agencies
The PM key responsibility is to assure that plans and resources are in place to achieve strategic deliverables for the therapeutic area
The PMs key customer outside of the CD&RA group is Regenerons Program Management organization which oversees global development planning and execution of the development strategy for the program
Other deliverables include:
o Status Updates to management (e.g., Head, CD&RA)
o Assure Delivery from Clinical Trial Managers (or equivalent) of:
Project Initiation
o Project Scope
o Project Charter
Project Planning
o Resource Plan & Team Roster
o Communications Plan
o Risk Analysis and Contingency Planning
Project Execution
o Updates & Guidance to senior management
o Team meetings as needed
o Facilitation of cross-department (ex-CD&RA) communications and collaboration
Project Closeout
o Debrief & Lessons Learned Exercise
Project Closeout Report (including Best Practices sharing)
Monthly, Quarterly, & Annual Project Updates
Monthly, Quarterly, & Annual Budget & Resource Reports
Experience and Required Skills:
Masters or doctoral level (PhD, PharmD, MD) with 10 years relevant pharmaceutical industry experience at least 4 of which are in project management
PMP certified (or PMI member) a plus
Strong working knowledge of Microsoft Project software
Previous track record as successful pharmaceutical project manager (>4 years)
Risk management and contingency planning skills
Strong Presentation Skills
Excellent written and oral communication
Ability to work across levels and across departments within Regeneron
Strong Leadership and interpersonal skills
Consensus builder but can take charge as needed.Estimated Salary: $20 to $28 per hour based on qualifications.
Regeneron
Job Summary and
Essential Functions:
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Associate Director, Therapeutic Area Project Management
Summary: Develops, drives, and directs operational plans for conducting clinical research, producing publications, and regulatory submission documents. Provides project management leadership and oversees/manages the planning, design, implementation, and completion of clinical research activities and regulatory correspondence.
Responsibilities: The Project Manager (PM) is the key partner to the Therapeutic Area (TA) Head. The TA Head is the Clinical and Scientific lead for the deliverables of the therapeutic area. The PM is the operational lead and dotted-line reports to the TA Head.
The PMs key deliverables are:
Clinical and Regulatory project schedules & budgets, critical path analyses, and risk assessment and management across the therapeutic area
Assurance of timely and high quality production of TA clinical and regulatory deliverables to internal and external customers and external regulatory agencies
The PM key responsibility is to assure that plans and resources are in place to achieve strategic deliverables for the therapeutic area
The PMs key customer outside of the CD&RA group is Regenerons Program Management organization which oversees global development planning and execution of the development strategy for the program
Other deliverables include:
o Status Updates to management (e.g., Head, CD&RA)
o Assure Delivery from Clinical Trial Managers (or equivalent) of:
Project Initiation
o Project Scope
o Project Charter
Project Planning
o Resource Plan & Team Roster
o Communications Plan
o Risk Analysis and Contingency Planning
Project Execution
o Updates & Guidance to senior management
o Team meetings as needed
o Facilitation of cross-department (ex-CD&RA) communications and collaboration
Project Closeout
o Debrief & Lessons Learned Exercise
Project Closeout Report (including Best Practices sharing)
Monthly, Quarterly, & Annual Project Updates
Monthly, Quarterly, & Annual Budget & Resource Reports
Experience and Required Skills:
Masters or doctoral level (PhD, PharmD, MD) with 10 years relevant pharmaceutical industry experience at least 4 of which are in project management
PMP certified (or PMI member) a plus
Strong working knowledge of Microsoft Project software
Previous track record as successful pharmaceutical project manager (>4 years)
Risk management and contingency planning skills
Strong Presentation Skills
Excellent written and oral communication
Ability to work across levels and across departments within Regeneron
Strong Leadership and interpersonal skills
Consensus builder but can take charge as needed.Estimated Salary: $20 to $28 per hour based on qualifications.
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