Associate Director, Nonclinical Development Program Management & Strategic Operations (Late-Stage Development)

The Associate Director, Nonclinical Sciences Program Management & Strategic Operations (PMSO) is responsible for the integration, planning, coordination, and execution of complex pharmaceutical development programs across the nonclinical development lifecycle. Working closely with Project Leaders, functional subject matter experts, Regulatory Affairs, and external partners, this individual develops and maintains integrated project and submission plans to ensure key development and regulatory milestones are achieved on time and within budget.

In addition to leading core program management activities, this role serves as a key operational lead for nonclinical regulatory deliverables supporting global marketing applications (NDA/BLA), health authority interactions, lifecycle management submissions, and post-marketing commitments, while also contributing to earlier-stage IND/CTA activities. The incumbent partners closely with Regulatory Affairs and cross-functional subject matter experts to coordinate planning, authoring, review, approval, and execution of nonclinical submission content across major regulatory milestones. This role also provides comprehensive communication, status reporting, risk management, and issue escalation support to cross-functional stakeholders and senior leadership.

KEY DUTIES & RESPONSIBILITIES

Program Leadership & Operations

• Establish project team operating norms and drive team effectiveness, accountability, and execution excellence.

• Independently lead cross-functional teams supporting critical development programs.

• Develop, maintain, and communicate integrated project plans that align functional deliverables with program objectives and timelines.

• Review and consolidate project plans, budgets, and resource forecasts; support scenario planning and evaluation of alternative development strategies, including associated risks and assumptions.

• Partner directly with CROs and external collaborators on the scheduling, execution, and reporting of key preclinical deliverables.

• Communicate program progress, timeline updates, risks, mitigation strategies, and opportunities to project teams and senior leadership.

• Track high-level program deliverables and proactively identify operational practices and technologies that improve execution.

• Forecast and manage program budgets, including oversight of programs managed by direct reports.

• May serve as study representative for nonclinical studies.

• Manage one or more direct reports, including professional development, performance management, and goal setting.

Regulatory Submission Planning & Execution

• Lead the planning, tracking, and execution of nonclinical deliverables supporting NDA/BLA marketing applications, IND/CTA applications, , supplemental filings, global submissions, and post-marketing regulatory commitments.

• Serve as the primary operational lead for nonclinical activities supporting marketing application submissions (NDA/BLA), including submission planning, document coordination, health authority response management, approval readiness, and post-marketing commitment execution.

• Partner closely with regulatory affairs and nonclinical SMEs to facilitate authoring, review, approval, and document readiness activities for regulatory submission packages, ensuring alignment across functional contributors.

• Develop and maintain integrated submission timelines, identifying critical dependencies, risks, and mitigation plans to ensure successful execution of regulatory milestones.

• Coordinate cross-functional activities supporting initial submissions, follow-on submissions, amendments, supplements, annual reports, and lifecycle management activities.

• Support preparation and tracking of responses to regulatory agency questions, information requests, and post-submission commitments in collaboration with Regulatory Affairs and functional experts.

• Ensure submission-related decisions, deliverables, timelines, and action items are appropriately tracked, communicated, and escalated when needed.

• Support global regulatory submission activities and facilitate alignment across regional and functional stakeholders to enable successful filings.

REQUIRED EDUCATION

• Bachelor's degree in a scientific discipline or related field.

REQUIRED EXPERIENCE

• Typically requires 10+ years of relevant experience in the pharmaceutical, biotechnology, or life sciences industry, or an equivalent combination of education and experience.

• Demonstrated experience in program management supporting nonclinical drug development programs.

• Experience supporting regulatory submission execution across multiple stages of development, including NDA/BLA submissions and other marketing application activities.

REQUIRED KNOWLEDGE & SKILLS

• Broad and comprehensive knowledge of GLP regulations.

• Comprehensive understanding of pharmaceutical drug discovery and development across multiple nonclinical disciplines, including toxicology, DMPK, biomarkers, translational sciences, and related functions.

• Strong understanding of nonclinical regulatory documentation, submission processes, and regulatory milestones across the product lifecycle.

• Experience coordinating cross-functional authoring, review, approval, and delivery of regulatory submission documentation.

• Demonstrated ability to manage complex regulatory and development timelines across matrixed teams.

• Experience driving submission readiness activities and coordinating cross-functional deliverables for major regulatory milestones.

• Excellent written, verbal, and presentation communication skills.

• Ability to influence decisions and drive outcomes across multidisciplinary teams.

• Strong understanding of functions and disciplines outside of one's own area of expertise.

• Strong organizational, planning, problem-solving, and risk management capabilities.

PREFERRED QUALIFICATIONS

• Significant experience supporting nonclinical deliverables for NDA/BLA marketing applications and post-approval regulatory activities; experience with IND/CTA submissions is expected, but late-stage development and filing experience is strongly preferred.

• Experience coordinating health authority response activities and post-marketing regulatory commitments in partnership with Regulatory Affairs and functional subject matter experts.

• Experience supporting global regulatory submissions across multiple regions, including FDA, EMA, MHRA, PMDA, and other international health authorities.

• Knowledge of, or experience working within, an outsourced nonclinical development model.

• Experience utilizing project management tools and processes to support complex cross-functional development programs.