Director, Therapeutic Area Project Manager

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.

The TAPM - Early Clinical Development provides project management leadership for the cross functional CDRA teams (eg: PVRM, Regulatory, Medical Monitoring, Clinical and Program Finance, Clinical Operations, etc.). Manages therapeutic areas clinical projects by overseeing the initiating, planning, execution, and closeout of the clinical development plans for clinical programs. Facilitates strategic planning for operational plans with CDRA and external partners as appropriate.

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:
o Status Updates to management (e.g., Head, CD&RA)
o 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)
o Monthly, Quarterly, & Annual Project Updates
o Monthly, Quarterly, & Annual Budget & Resource Reports
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Requirements:

Advanced degree preferred and minimum of 15+ years relevant industry experience.

• Strong interpersonal & leadership skills

• Ability to provide strategic direction and guidance to teams aligned with clinical development plans

• Anticipates new trends in a competitive landscape and therapeutic areas to guide the organizational strategy

• Provides a comprehensive industry perspective for project management execution

• Strong analytical skills with a data driven approach to planning, executing, and problem solving

• Effective communication skills to all levels of the organization

• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

• Accomplished influencing and negotiation skills

• Proficient in creating and maintaining clinical program budgets and timelines

• Exceptional project management, cross-functional team leadership, and organizational skills

• Ability to build successful and effective teams and collaborations internally as well as with external partners

• Line management experience with demonstrated mentoring and coaching skills

• In depth knowledge of GCP and ICH

Education

• Masters or doctoral level (PhD, PharmD, MD, MBA); undergraduate technical/scientific degree
Experience

• 15 years relevant FDA regulated industry experience preferably with drug development; at least ten of which are in project management
Certifications

• Project Management Professional (PMP)® - preferred

• NIH certification on the Protection of Human Research Subjects - preferred

Key Team Membership (including but not limited to):
CTM Leadership Team
Vendor Governance Committee(s)
Clinical Operations Review Meeting(s)
Development Team(s)
Clinical Compliance Meeting(s)
Strategy Review Meeting(s)

Cross Functional Interfaces (including but not limited to):
Interface with key clinical and regulatory functional area leads
Program Management
Medical Director(s)
Procurement
Corporate and Clinical Finance
Clinical Trial Management
Medical Writing

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

LMR, Director TAPM, Director Clinical Trial Project Manager, Project Manager, Dir TAPM, Thereapeutic Area Project Manager, Clinical Project Manager, #LI-LR1
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