Sr. Director/Executive Director, Program Leader, CLYM116 About

Climb Bio•Newton, MA

3d•$300,000 - $335,000•Hybrid

About The Position

This is a cross-functional leadership role accountable for defining and executing the asset strategy of CLYM116 and for leading late-stage development, registration, and life-cycle management for the program. The Program Leader will report to our Chief Business Officer and is responsible for leading and driving performance of the program team, ensuring alignment of program strategy, timelines, resources, and operational execution, and delivery against goals and is the line manager for asset Program Manager(s). The role also serves as the company’s main alliance manager with our partner, running the collaboration day to day and making sure both companies stay aligned on development, regulatory, CMC, and commercial priorities.

Requirements

14+ years of biotechnology or pharmaceutical drug development experience, with progressive accountability for an integrated development plan at the program or asset level.
Demonstrated experience leading a program through Phase 3 to approval and launch.
Experience supporting global regulatory interactions and major regulatory submissions.
Deep understanding of global drug development, including knowledge of clinical development (protocol and endpoint strategy, regulatory pathway, and clinical data interpretation).
Demonstrated ability to integrate commercial and competitive insights into development decisions, including target product profile and positioning.
Proven ability to lead and hold accountable a cross-functional matrix team without direct reporting authority.
Strong business acumen and financial awareness.

Nice To Haves

Advanced degree in life sciences, medicine, or business (PhD, MD, PharmD, MBA, or equivalent).
Experience in IgA nephropathy, glomerular disease, or other immune-mediated indications.
Experience developing biologics or monoclonal antibodies.
Experience contributing to brand or launch planning, including market research and forecasting.
Experience operating in a lean, clinical-stage organization where program leaders work hands-on across functions.
Experience presenting to executive teams and boards of directors.
Experience managing a co-development, licensing, or collaboration partnership.

Responsibilities

Develop, maintain, and own the asset strategy for CLYM116 - the integrated global development plan, its underlying assumptions, and its performance against them - from late-stage development through launch.
Develop and own the lifecycle management strategy for CLYM116 beyond initial launch - indication expansion, combination opportunities - to sustain and grow the asset's value over its full commercial life.
Lead the cross-functional CLYM116 program team across key disciplines, including Clinical Development, Clinical Operations, Regulatory, CMC, Medical Affairs, Finance, and Commercial, setting the vision, strategy, goals and priorities and holding the team accountable for an aligned plan and delivery.
Serve as alliance lead for the program. Build trusted partner relationships at the working and executive levels, chair joint governance (JSC, JDC, and working groups), and manage contract obligations and milestones with Legal, Finance, and Corporate Development. Identify and resolve issues early and keep collaboration and decision making between the companies running smoothly.
Partner with Program Management to translate asset strategy into the execution plan, timelines, interdependencies, and resourcing - maintaining a shared view of what the program has committed to and where it stands against it. Program Leader owns the integrated program plan with the asset Program Manager leading day-to-day execution.
Lead program level governance and work with Program Management to establish clear governance processes, decision frameworks, and accountability mechanisms.
Partner with CMC to ensure readiness in supply chains and serve as a leader in the manufacturing and supply strategy.
Partner with R&D, including Clinical Development and Clinical Operations, on scientific rationale, study design and execution, operational feasibility, and data interpretation to ensure the development plan is scientifically sound and operationally executable.
Partner with Commercial and Corporate Strategy on market research, competitive intelligence, and forecasting for the asset, and translate those insights into development decisions such as indication sequencing, target product profile, target population, endpoint and comparator selection, and label strategy.
Serve as the external face and voice of CLYM116, building and sustaining external relationships and representing Climb with external partners, collaborators, investigators, key opinion leaders, and at advisory boards, investigator meetings, and scientific congresses.
Drive decision making, framing program-level trade-offs, scenarios, and recommendations for the Leadership Team and Board with clear, documented rationale.
Work with functional leaders to ensure aligned and accurate input into CLYM116 program budget, including monitoring and controlling expenditures, guiding annual and long-range plan inputs, and partnering with Finance on resourcing, phasing, and scenario costs.
Manage program-level risk, dependencies, and critical path across timelines, enrollment, data delivery, and supply; proactively identifying challenges and contingency plans as appropriate.
Represent CLYM116 in business development assessments, diligence activities, and partnership evaluations, providing the asset perspective on scientific and commercial fit, and support internal portfolio prioritization with a current view of the program's value and risk.