Associate Director, Therapeutic Area Project Management

Basking Ridge, New Jersey
Sep 23, 2021
Required Education
Bachelors Degree
Position Type
Full time

The Associate Director, Therapeutic Area Project Management (TAPM) provides project management leadership for the cross functional clinical development teams, ensuring targets are met on time and with quality. We are looking for a leader to be accountable for the assigned therapeutic area clinical portfolio. You will plan strategy and develop and supervise the program budget and timelines against the baseline. You facilitate decision-making, drive activities to completion, troubleshoot issues and identify and mitigate risks within the clinical program, and with external partners.

In this role, a typical day might include the following:

•Coordinating and driving the clinical strategy to completion across the various development phases within scope, timelines and budget
•Working closely with equivalent portfolio functional leaders to ensure objectives are being met within the therapeutic area(s)
•Encouraging a productive and positive team environment and collaborating closely with the development program manager, operations lead, clinical development lead and Therapeutic Area Head.
•Facilitating clinical development team meetings and translating the strategic clinical goals into operational plans.
•Driving the discussions related to early planning to develop the studies that will form the development plan and integrated clinical timelines.
•Coordinating scenario planning to provide management with decision-making information, such as high-level timelines and costs.
•Accountability for the budget development process and facilitating the budget approval process with the clinical study team managers. 
•Participating in the quarterly re-forecast cycle to ensure the clinical assumptions are current and accurate within the operational development plan documents.
•Finding opportunities for standardization and providing leadership in resulting workstreams and initiatives.
•Crafting and authoring functional Standard Operating Procedures (SOPs), guidance documents and onboarding/training.
•Identifying trends for risks and developing mitigation strategies across portfolio.
•Facilitating action follow-up and issue resolution within the matrix-environment in order to attain portfolio goals.
•Leading and participating in Lessons Learned debriefs.
•Serving as the main point of contact for assigned portfolio assets related to progress, objectives, clinical budgets and timelines. 
•Coordinating and supervising these related activities with the assigned TAPM staff in their portfolio remit.
•Ability to travel up to 25%

This role may be for you if:
You have shown success working effectively within matrix environments in the drug development / pharmaceutical industry
You have expertise in planning, organization and time management skills, including being adept at overseeing multiple therapeutic areas and prioritizing multiple projects.
You have advanced knowledge of clinical/operational budgeting and timeline development, capable of evaluating critical path and program interdependencies.
You are comfortable in a highly visible role that regularly interacts with executive levels on clinical project status and goals.
You have a strong understanding of relevant laws and policies guiding the pharmaceutical industry (e.g. ICH/GCP Guidelines) 
You have the ability to coach and mentor junior staff, serving as a role model for the function and organization
You have proven ability to influence senior management to reach desired outcomes
You are able to challenge, while also engendering trust, placing the needs of the organization/team before your own. 

To be considered you must have a BS/MS Degree with typically 10+ years of relevant project management experience in the pharmaceutical / biotech industry. An Advanced degree (PhD, PharmD, MBA) is preferred and PMP certification is also desired. Proficiency in relevant software is also vital: MS Excel, PowerPoint, Word, Project/OnePager.

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 singock 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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