Executive Director, Global Program Manager

Kardigan•Princeton, NJ

3d•Hybrid

About The Position

Kardigan is seeking an Executive Director, Global Program Manager to act as the “COO” of a Global Program Team (GPT) for one of our late-stage programs, working hand-in-hand with the Global Program Head (GPH) to connect strategy to execution across the full development lifecycle — from ongoing late-stage development through regulatory submission and, in the event of approval, launch readiness and lifecycle management. The initial assignment is the tonlamarsen (TLA) program. Tonlamarsen is an investigational, once-monthly, subcutaneous, liver-directed antisense oligonucleotide targeting hepatic angiotensinogen. The current strategy is to establish proof of concept in the Phase 2 KARDINAL-ASH trial by evaluating sustained blood pressure reduction in high-risk patients with established cardiovascular or kidney disease after a recent acute severe hypertension event. The program’s upcoming milestones — data readouts, health authority interactions, the Phase 3 decision and the cross-functional coordination required by the Ionis alliance — demand a program manager who has led late-phase development before and, ideally, has taken an asset through filing and launch. This is a program leadership role, not a project coordination role. The Executive Director is a strategic partner to the GPH with deep, first-hand knowledge of how clinical, regulatory, CMC, medical and commercial workstreams interlock in late-phase development, regulatory submission and launch. The role leads through influence, holds the integrated view of the program at all times, and owns the machinery that makes the program run. As the program management function grows, the Executive Director will also mentor and develop Global Program Managers and help build Kardigan’s program management capability, processes and tools.

Requirements

BS or MS in a scientific, engineering or health-related discipline; advanced degree (PhD, PharmD, MD, MBA) a plus.
15+ years of biopharmaceutical industry experience, including 8+ years in cross-functional program management on development-stage assets.
Has served as the Global Program Manager (or equivalent program-level leader) on a Global Program Team or equivalent core team for at least one asset in late-phase development (Phase 2b/3).
Has led development of an integrated development (and commercialization) plan for a late-phase asset, including facilitating cross-functional trade-offs and building alignment on the plan of record.
Has prepared and presented governance and stage-gate packages, including scenario and contingency options, to executive-level decision bodies.
Has run cross-functional program and clinical team governance — agenda, pre-reads, minutes, decision and action logs — for a late-phase program and is comfortable sitting on both a program team and a clinical team and keeping them aligned.
Deep, demonstrable understanding of how clinical, regulatory, CMC, medical affairs and commercial workstreams interlock in late-phase development, regulatory submission and launch — able to anticipate issues and recommend mitigations across functions, not only track them.
Experience managing partnered or in-licensed assets, including alliance governance and partner-company coordination.
Proven ability to lead through influence in a matrixed environment, and to run workstreams and cross-functional teams while personally delivering the work.
Experience in a smaller or high-growth biotech environment, or a demonstrated ability to transition from large-company infrastructure to a resource-conscious, fast-moving setting.
Program leadership. Thinks and acts as the GPH’s operational counterpart; holds the integrated view and drives the program to decisions, not just to milestones.
Development judgment. Understands the content of the work well enough to challenge functional plans, spot critical-path risk early and frame real trade-offs.
Executive communication. Translates program complexity into clear, executive-ready insight for the Executive Committee, Board and alliance partners.
Facilitation and team health. Builds psychological safety and shared accountability; designs the forums and norms that keep a cross-functional team decisive.
Rigor and urgency. Disciplined documentation, risk governance and version control; operates with a start-up sense of pace and resilience.
Patient-centric orientation. Ensure program execution ultimately serves patients and their families.

Nice To Haves

Has taken an asset through regulatory submission (a New Drug Application or Biologics License Application) and U.S. launch as the Global Program Manager or a core program team member — owning or directly contributing to submission planning and launch-readiness workstreams.
Experience with small-molecule or oligonucleotide/RNA-targeted programs, or with cardiovascular/cardiometabolic programs.
Experience leading or building a program management function and developing program managers.
Project Management Professional (PMP) or equivalent certification; experience with program and portfolio planning platforms.

Responsibilities

Serve as the GPH’s strategic partner: develop and stress-test program strategy, challenge assumptions, and translate strategy into executable integrated operating plans.
Act as the primary integrator across GPT functions — Clinical Development, Regulatory, CMC, Nonclinical, Medical Affairs, Commercial, Finance and Legal — facilitating high-quality, timely decisions and resolving cross-functional dependencies, bottlenecks and trade-offs before they become program risks.
Model shared accountability and a program-first mindset across the GPT and its sub-teams.
Run both rooms (Global Program Team and Global Clinical Team). Serve as a full-time core member of the GPT alongside the GPH, and hold a core seat on the GCT, which is co-chaired by the Clinical Development Lead and the Clinical Operations Program Lead.
Own the agendas, circulate the pre-reads, keep the decision and action logs, and make sure every session ends with decisions, owners and dates.
Be the connective tissue between the two bodies (GPT and GCT). Carry GPT taskings down to the GCT with the question, the decision it feeds and the date it is needed and carry GCT recommendations back up for endorsement.
Hold the line on what decision-ready means: alternatives evaluated, functions consulted, disagreement named, and the implications for goals, budget, timelines and risk spelled out.
Own the plan of record. Maintain the Integrated Development & Commercialization Plan as a living document and the single source of truth for program status, decisions and assumptions across both governance bodies and the five function-led sub-teams.
Build the governance packages the GPH carries to the Executive Committee and to Monthly Portfolio Strategy and apply the threshold rule so that anything moving risk profile, timelines, cost or opportunity potential is escalated as a recommendation rather than an open question.
Apply RAPID decision rights so that every decision has a single Recommender and a single Decider.
Own the program's charter and seat list, run the annual review and the team health assessment, and guard against the failure modes the charters name — re-litigating decisions, confusing decision rights, and escalating instead of solving.
Apply deep, first-hand late-phase drug development expertise — Phase 3 design and execution, regulatory submission, CMC readiness, launch readiness and lifecycle management — to identify risks and acceleration opportunities across the IDCP.
Lead the development and evolution of the IDCP — the plan of record into which the Clinical Development Plan (from the GCT), the Integrated Evidence Plan (from the Medical Strategy Team) and the Integrated Product Strategy roll up: drive functional input, surface and resolve trade-offs, assess risk and build cross-functional alignment, and prepare the Integrated Development & Commercialization Plan for recommendation by the GPH to MPS.
Lead program-level planning for health authority submissions (maintenance of the Investigational New Drug application, end-of-Phase 2 and pre-New Drug Application (NDA) interactions, and NDA planning and execution) in partnership with Regulatory Affairs and lead cross-functional launch-readiness planning in anticipation of potential approval.
Coordinate program deliverables, data exchanges and obligations under the alliance agreement (Ionis for TLA) in partnership with Regulatory Affairs, Legal and functional leads, ensuring alliance commitments are tracked and reflected in integrated program plans.
Own integrated program timelines, critical path, budgets and resource forecasts across all functions, ensuring plans reflect current strategy and realistic assumptions.
Own core program documentation — IDCP, Target Product Profile inputs, dashboards, risk registers, decision logs and version-controlled program records — in accordance with Kardigan policies and standard operating procedures (SOPs).
Lead scenario planning and contingency strategy; present alternative development and risk-management scenarios, options and recommendations to the GPT and senior leadership with executive-ready framing.
Own governance packages and milestone-readiness reviews; facilitate governance forums and lead drafting of executive materials so that program decisions are framed with rigor, transparency and strategic context.
Ensure GPT readiness at every inflection point, including data readouts, health authority interactions, stage-gate decisions and submission milestones.
Represent program health and the strategic narrative to the Executive Committee, Monthly Portfolio Strategy and, when required, the Board of Directors; maintain a single source of truth for program status and decisions.
Facilitate stakeholder pre-alignment to ensure efficient decision-making and limit decision churn.
Create psychological safety and shared accountability across the GPT and sub-teams; design meeting cadence, working norms, decision rights and communication pathways that keep the team effective.
Design and facilitate workshops that advance strategy, align cross-functional operating activities and drive outcomes.
Mentor and develop Global Program Managers; contribute to building world-class GPM capability, processes and tools across the organization, driving standardization, simplification and continuous improvement.