Associate Director Therapeutic Area Project Mgmt
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 Associate Director Therapeutic Area Project Management provides project management leadership for the cross functional clinical development teams, ensuring deliverables are met on time, within budget and in accordance with quality expectations.
For the assigned therapeutic area(s), they support the planning of the clinical strategy, develop and monitor the clinical program budget and timelines against the baseline. Facilitates strategic planning and decision-making, drive activities to completion, troubleshoots issues, and identifies/manages risks within the clinical program and with external partners, as appropriate.
• Teams: Guides and facilitates the clinical development team to plan and execute the clinical program's goals for the assigned assets within a therapeutic area(s). Coordinates and drives the clinical strategy to completion across the various development phases (e.g. pre-IND to life cycle management) within scope, timelines and budget.
• Communication and Collaboration: Manages the clinical program interactions to ensure that the cross-functional teams are aligned on the deliverables and successfully set up to execute. Fosters a productive and positive team environment and collaborates closely with the development program manager, operations lead and clinical development lead. Liaises between the strategic development team and the clinical development team to communicate relevant and contemporaneous inputs/outputs from each team. Effectively facilitates the clinical development team meetings and translates the strategic clinical goals into operational plans. For collaborator programs, will act as the conduit to provide status reports on internal clinical and operational activities.
• Planning: Drives the discussions related to early planning to develop the studies that will form the clinical development plan and integrated clinical timelines. Facilitates the protocol expanded synopsis process from collection of early assumptions to document finalization with associated budget and timelines. Collaborates with clinical logistics to provide assumptions for early drug supply planning. Plan and monitor the clinical deliverables required for regulatory submissions (e.g. IND, CTA, BLA, MAA, etc.)
• Project Reporting and Tracking: Maintains knowledge of key data and milestones for assigned projects and serves as the primary contact for information and updates. Provides project summaries and general guidelines to support presentations to senior management and collaborators as needed.
• Budgets and Timelines: Participates in scenario planning to provide management with decision-making information, such as high-level timelines and costs. Coordinates with the cross-functional team and gains alignment on the assumptions that will drive the initial budget and timelines. Accountable for the budget development process and facilitates the budget approval process with the clinical study team. Participates in the quarterly reforecast cycle to ensure the clinical assumptions are current and accurate within the operational development plan documents. Oversees clinical study timelines and performs ongoing assessment of current timelines against the baseline.
• Process Improvement: Identifies opportunities for standardization and best practices and provides leadership in resulting workstreams and initiatives. Creates and authors functional Standard Operating Procedures (SOPs), guidance documents, onboarding/training for both the TAPM function and within the Global Development organization.
• Problem Solving and Risk Identification: Identifies risks and develops/manages mitigation strategies. Facilitates action follow-up and issue resolution within the matrix-environment of the clinical development team in order to deliver against project goals. Leads and participates in Lessons Learned debriefs.
NATURE AND SCOPE:
• Ability to work independently with minimal guidance from supervisor.
• Works cross-functionally in a matrix organization (e.g. clinical sciences, clinical trial management, data management, biostatistics, medical writing, regulatory, pharmacovigilance, finance, clinical logistics, etc.) to deliver the clinical development plan.
• Highly visible role that regularly interacts with executive levels on clinical project status and goals. May be the point of contact for one or more therapeutic areas regarding progress on the project(s).
Knowledge and Skills
• Advanced knowledge and understanding of working effectively within matrix environments in the drug development / pharmaceutical industry
• Understanding of relevant laws and policies guiding the pharmaceutical industry (e.g. ICH/GCP Guidelines)
• Core competencies: Proven leadership skills with the ability to build strong relationships with internal and external customers and foster a positive team environment. Excellent verbal, interpersonal and written communication skills. Excellent planning, organization and time management skills (project and self), including the ability to support and prioritize multiple projects. Excellent problem-solving skills with the ability to work collaboratively in a fast-paced environment and can adapt to changing priorities and deadlines. Demonstrated negotiation skills and ability to exert influence with senior management to reach win-win situations.
• Advanced knowledge of clinical/operational budgeting and timeline development with the ability to evaluate critical path and program interdependencies
• Proficient experience in relevant software: MS Project/OnePager, Excel, PowerPoint, Word
• Supervision: Typically reports to a Director / Senior Director
Education and Experience
• BS/MS Degree with typically 10+ years of relevant progressive project management experience in the drug development / pharmaceutical industry
• Advanced degree (PhD, PharmD, MBA) preferred
• PMP certification desired
• Experience in line management with accountability for individual performance management (i.e., setting goals and expectations, conducting performance reviews) is preferred.
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.
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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.