Drug Development Senior Program Manager

Integrated Resources, Inc ( IRI ); Cambridge (MA); Hybrid; USD 130,000 - 160,000; Full time

Job summary

A leading biotechnology firm is seeking an experienced Senior Program Manager to oversee drug development processes. The role requires at least 10 years of experience in drug development project management, ideally with a background in various therapy areas. Candidates should possess an advanced degree and proven success in complex program delivery and regulatory processes. The position offers a hybrid work environment in Cambridge, MA or Princeton, NJ and seeks a proactive leader to drive program strategies.

Qualifications

• 12+ years of industry experience with 10 years in drug development project management.
• Experience in nearly all phases of drug development including regulatory submissions.
• Strong executive presence and ability to influence senior leadership.

Responsibilities

• Deliver as a key partner to the Global Program Lead.
• Execute the Integrated Development Plan for assigned assets.
• Lead risk management activities and maintain budget oversight.

Skills

Drug development experience

Regulatory experience

Project management

Matrix leadership

Influencing senior leadership

Education

Advanced degree in Life Sciences or related field

PMP certification

Job description

Can be hybrid in Cambridge, MA or Princeton, NJ

Work Schedule: Mon-Fri 8am-5pm

Top Requirements

At least 10 years of drug development experience spanning early development (Ph1) through commercialization; regulatory experience is preferred; advanced degree (MBA, MS, PhD) preferred, PMP preferred; Neuroscience experience preferred

Position Summary

The Senior Program Manager, is assigned to early and/or late development stage asset(s). They operate as a strategic partner to the Global Program Lead (GPL), to shape and deliver the Target Product Profile (TPP) and Integrated Development Strategy (IDP) for the assigned asset(s) and associated product indications. Responsible for the rigorous execution of the IDP individually or in partnership with assigned Program Management team members.

Duties/Responsibilities

• Program Management SME delivering as a key partner to the GPL. Serves as the strategic thought partner to the GPL / GPT and core to establish a high performing team environment.
• Responsible for the execution of IDP per asset indication, this includes strong partnership with each sub-team and their leadership to ensure alignment to the TPP/IDP and clear understanding of what they are accountable to deliver.
• Leads matrixed PM team members to create and maintain integrated cross-functional timelines for each asset indication within approved systems. Timelines should include scenario plans that actively manage risk, evaluate alternative development strategies as well as acceleration opportunities (or cost savings).
• Leads risk management activities at the GPT and ensures risk management activities at the sub-teams and below are performed with timely escalation for high probability x high impact risks. Responsible for delivering the risk management plan, including risk mitigation strategies.
• Responsible to monitor high level direct budget and resource health for assigned asset(s) and indications. Maintains visibility and advocates for the resources required to deliver the IDP per governance approval.
• Delivers as a PM SME in discussions with leadership or at governance stage gates.
• Supports GPT annual objective processes and budget planning including annual and long-term portfolio processes.
• May serve as a matrix manager for Program Management resources assigned to the asset.
• Foster cross-functional thinking to drive and shape program strategy and drive optimal decisions for the broader portfolio.
• Expected to lead as a change agent and a strong representative of the DD PM department vision and ways of working.

Qualifications

• Advanced degree (MS/MBA or Ph.D. desirable) in Life Sciences, Chemical Sciences, Physical Sciences, or other relevant discipline. PMP certification is desirable.
• 12+ years of industry experience, with at least 10 years of direct experience in drug development program / project management. Ideal candidates will have experience in various therapy areas.
• Demonstrated experience in nearly all phases of research and drug development, including global regulatory submissions (IND/CTA through NDA/BLA/MAA/JNDA/ NDA China) and lifecycle management.
• Proven success as a PM delivering complex programs teams with high level of enterprise visibility. Long-standing experience which demonstrates strong matrix leadership abilities.
• Strong executive presence with ability to present, influence, and gain alignment at senior governance and executive leadership levels.