Summary
✨ AI‑Generated
A senior program leader is sought to coordinate complex pharmaceutical development initiatives, manage cross-functional teams, and support clinical strategies from early research through advanced development stages.
Highlights
Lead strategic development programs across the pharmaceutical lifecycle while collaborating with multidisciplinary teams and driving high-impact clinical initiatives.
Description
Overview
Our client is seeking 2 Drug Development Program Managers to support development programs across the drug development lifecycle.
These individuals will partner with Global Program Leads (GPLs), Global Project Managers (GPMs), Clinical Science, Therapeutic Area leadership, and cross-functional teams to drive Integrated Development Plans (IDPs), strategic execution, governance, and risk management activities.
Req #1 (Princeton, NJ preferred | Cambridge Crossing, MA secondary): Immunology and Cardiovascular focus.
Open to either a traditional Drug Development Program Manager or Scientific Program Manager profile.
Late-stage development experience is required, with Phase II/III and submission-facing experience highly desirable.
Req #2 (Brisbane, CA): Cell & Gene Therapy focus.
Candidate will initially support two assets spanning candidate identification through First-in-Human studies within solid tumor and autoimmune disease programs.
Cell & Gene Therapy and asset-level Program Management experience are required.
Responsibilities:
Partner with GPLs, GPMs, Clinical Science, and cross-functional stakeholders to develop and execute drug development strategies.Develop and manage Integrated Development Plans (IDPs), program timelines, milestones, and critical path activities.Lead cross-functional planning and execution across Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, CMC, Safety, and Nonclinical functions.Support programs from IND-enabling activities through clinical development and key regulatory milestones.Drive governance, risk management, scenario planning, resource forecasting, and budget planning activities.Partner with Clinical Operations to support study execution and issue resolution.Drive accountability across matrixed teams and prepare executive-level communications and governance materials.Promote operational excellence and continuous improvement initiatives.Qualifications:
Advanced degree (PhD preferred) in a relevant scientific discipline.BS/MS in a scientific discipline with 8-10+ years of biotech, pharma and/or relevant drug development experience will also be considered.Experience supporting development programs from early development through clinical development.Strong understanding of clinical, regulatory, nonclinical, and CMC activities within the drug development lifecycle.Experience leading complex cross-functional programs within matrixed organizations.Strong program planning, governance, risk management, stakeholder management, and communication skills.Ability to work onsite 3 days per week (50%).
Req #1: Strong pharmaceutical drug development experience and stakeholder management capabilities.
Late-stage development experience required.
Scientific Program Manager candidates should have systems/process management experience and familiarity with Microsoft tools/SharePoint.
Req #2: Cell & Gene Therapy experience required.
Strong scientific background, experience serving as lead PM on an asset, and early-stage development experience supporting candidate readiness through First-in-Human studies required.
Preferred Qualifications:
Req #1: Immunology and/or Cardiovascular experience, phase II/III and submission-facing experience, regulatory submission experience.
Req #2: Prior asset-level leadership experience.
PMP certification and experience with Microsoft Project, Office Timeline, SharePoint, or similar project planning tools is a plus for both.