Asc Dir, Therapeutic Area Project Manager

Location
Tarrytown, NY
Posted
Mar 22, 2019
Ref
15648BR
Required Education
Masters Degree/MBA
Position Type
Full time
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 commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

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.

Job Duties:

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 PM's 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 PM's key customer outside of the CD&RA group is Regeneron's Program Management organization which oversees global development planning and execution of the development strategy for the program

Other deliverables include:

Assure Delivery from Clinical Trial Managers (or equivalent) of Project Initiation

Project Scope

Project Charter

Project Planning

Resource Plan & Team Roster

Communications Plan

Risk Analysis and Contingency Planning Project Execution
Updates & Guidance to senior management

Team meetings as needed

Facilitation of cross-department (ex-CD&RA) communications and collaboration Project Closeout

Debrief & Lessons Learned Exercise

Project Closeout Report (including Best Practices sharing)

Monthly, Quarterly, & Annual Budget & Resource Reports

Requirements:

PMP certified (or PMI member)

• 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

Education:

Masters or doctoral level (PhD, PharmD, MD)
  • 10 years relevant pharmaceutical industry experience at least 4 of which are in project management