VP, Program Management

Proclinical Staffing; Boston (MA); On-site; USD 300,000 - 520,000; Full time

Job summary

Proclinical Staffing is seeking a Vice President of Program Management in Massachusetts to lead the strategic direction and execution of a key oncology program. The role requires deep drug development expertise and the ability to align clinical, regulatory, CMC, medical affairs, and commercial teams toward a shared vision.

The successful candidate will integrate diverse functions into a cohesive strategy, manage critical paths, and engage with executive leadership.

Qualifications

• Extensive experience in drug development across clinical, regulatory, and technical operations.
• Proven leadership in managing late-stage assets and global regulatory submissions.
• Strong cross-functional leadership, governance, and decision‑making skills.

Responsibilities

• Serve as the accounta bility for overall program strategy and execution.
• Integrate functional perspectives into a unified strategy to maximize program value.
• Represent the program at executive leadership and board meetings with updates and recommendations.
• Manage critical paths, risk mitigation, and scenario planning to maintain aggressive timelines.
• Collaborate with Regulatory Affairs to develop global regulatory strategies including FDA/EMA engagements.
• Oversee regulatory submissions such as IND amendments and NDA/BLA/MAA filings.
• Foster a collaborative team environment and mentor team members.

Skills

Drug development

Cross-functional leadership

Decision making

Resource planning

Cross-functional governance

Education

Advanced degree (MD/PhD/PharmD)

Job description

VP, Program Management - Permanent - Massachusetts, US

Can you unite clinical, regulatory, CMC, medical affairs, and commercial teams behind a single vision to deliver a transformational oncology therapy?

Proclinical is seeking a Vice President of Program Management to lead the strategic direction and operational execution of a key oncology program. The position requires a strong leader with deep drug development expertise, strategic vision, and the ability to align cross-functional teams toward shared goals.

Primary Responsibilities:

The successful candidate will be involved in integrating clinical, regulatory, CMC, medical affairs, and commercial functions into a cohesive strategy to support the approval and commercialization of a late-stage asset.

Skills & Requirements:

• Comprehensive experience in drug development, with expertise across clinical, regulatory, and technical operations.
• Proven leadership in managing late-stage assets through pivotal trials and global regulatory submissions.
• Strong decision-making skills, with the ability to balance cross-functional trade-offs.
• Hands-on experience with resource allocation against development milestones.
• Advanced degree (e.g., MD, PhD, PharmD, or MD-PhD) in a relevant scientific or clinical discipline preferred.
• Background in oncology drug development, particularly in rare solid tumors or hematologic malignancies, is highly desirable.
• Experience with commercial launch planning, label strategy, or market access integration is a plus.
• Ability to navigate organizational governance, build coalitions, and drive decisions effectively.

The VP, Program Management's responsibilities will be:

• Serve as the single point of accountability for the overall program strategy and execution.
• Integrate diverse functional perspectives into a unified strategy to maximize program value.
• Represent the program at executive leadership and board meetings, providing updates and recommendations.
• Manage critical paths, scenario planning, and risk mitigation with a proactive approach.
• Partner with Regulatory Affairs to develop and execute global regulatory strategies, including FDA, EMA, and other health authority engagements.
• Oversee key regulatory submissions such as IND amendments, briefing documents, and NDA/BLA/MAA filings.
• Address roadblocks and resolve cross-functional challenges to maintain aggressive timelines.
• Foster a collaborative team environment, mentor team members, and promote a shared sense of mission.
• Build relationships with clinical thought leaders, patient advocacy groups, and key external partners.