Senior Manager, Therapeutic Area Project Management

Location
Tarrytown, NY, United States
Posted
May 01, 2021
Ref
23811BR
Required Education
Bachelors Degree
Position Type
Full time
The Senior Manager Therapeutic Area Project Management provides project management leadership for the cross functional clinical development teams, ensuring established goals are met on time, within budget and in accordance with quality expectations.

As the Senior Manager, you will support the planning of the clinical strategy. You will also develop and monitor the clinical program budget and timelines against the baseline for your therapeutic area. You'll also facilitate planning and decision-making, driving activities to completion, and trouble shooting issues.

In this role, a typical day might include:

  • Guiding and facilitating the clinical development team to plan and execute the clinical program's goals for the assigned assets within a therapeutic area(s).
  • Coordinating and driving the clinical strategy to completion across the various development phases (e.g. pre-IND to life cycle management) within scope, timelines and budget.
  • Leading program interactions to ensure that the cross-functional teams are aligned on the deliverables and optimally set up to execute.
  • Collaborating closely with the development program manager, operations lead and clinical development lead.
  • Liaising between the strategic development team and the clinical development team to communicate relevant and contemporaneous inputs/outputs from each team.
  • Facilitating team meetings and translating the strategic clinical goals into operational plans. For collaborator programs, also acting as the conduit to provide status reports on internal clinical and operational activities.
  • Driving discussions related to early planning to develop the studies that will form the clinical development plan and integrated clinical timelines.
  • Facilitating the protocol expanded synopsis process from collection of early assumptions to document finalization.
  • Partnering with clinical logistics to provide assumptions for early drug supply planning.
  • Planning and supervising the clinical results required for regulatory submissions (e.g. IND, CTA, BLA, MAA, etc.)
  • Maintaining knowledge of key data and landmarks for assigned projects and serving as the liaison for information and updates.
  • Providing project summaries and general guidelines to support presentations to senior management and collaborators as needed
  • Participating in scenario planning to provide management with decision-making information, such as high-level timelines and costs.
  • Being accountable for the budget development process and coordinating the budget approval process with the clinical study team.
  • Participating in the quarterly re-forecast cycle to ensure the clinical assumptions are current and accurate within the operational development plan documents.
  • Potentially participating in workstreams, initiatives and review functional Standard Operating Procedures (SOPs) within the Global Development organization
  • Identifying risks and developing and managing mitigation strategies.
  • Facilitating action follow-up and issue resolution within the matrix-environment, including leading and participating in Lessons Learned debriefs.
  • Having ability to travel up to 25%
This role might be for you if:
You have proven planning, organization and time management skills (both for a project and yourself), including the ability to support and prioritize multiple projects at once
You are capable of working well independently or collaboratively in a fast-paced environment with frequently changing priorities
You thrive in a highly visible role that interacts with executive levels on clinical project status and goals
You're passionate about fostering a productive and positive team environment
You understand relevant laws and policies guiding the pharmaceutical industry (e.g. ICH/GCP Guidelines)

To be considered, you must have a Bachelor's degree with at least eight years of relevant progressive project management experience in the drug development / pharmaceutical industry. You also must possess sophisticated knowledge of clinical/operational budgeting and timeline development with the ability evaluate critical path and program interdependencies. Advanced experience in MS Project/OnePager, Excel, PowerPoint, Word is also vital for success. Translational/experimental medicine study experience is preferred.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
 
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