Bachelor's degree required; MBA, PMP, or advanced scientific degree preferred.
10+ years in biopharma, with 5+ years in clinical operations or R&D business operations at a sponsor.
Cross-functional exposure to clinical development, medical affairs, and pharmacovigilance; small-biotech experience valued.
Experience with clinical budgets, accruals, vendor contracts, and R&D planning cycles.
Strong portfolio reporting skills using CTMS, Excel, or BI tools.
Responsibilities
Run the Development annual goals and operating plan with the Head of Development.
Translate corporate priorities into functional plans and track delivery against goals.
Prepare executive materials on the Development portfolio, progress, and risks.
Coordinate cross-functional governance across Clinical Development and related areas.
Program-manage cross-functional initiatives like inspection readiness and process harmonization.
Maintain a portfolio view of all studies, tracking milestones and risks.
Coordinate the budget cycle and track variances with Finance and study leads.
Benefits
Collaborative work environment with a focus on team development.
Opportunities for professional growth and advancement.
Engagement in cross-functional initiatives that impact the organization.
Access to advanced tools and systems for project management.
Support for hiring and onboarding processes.
Full Job Description
POSITION SUMMARY:
The Program Director, Strategy & Operations is the Head of Development's partner in running the business of the Development organization: Clinical Sciences & Operations, Clinical Development, Medical Affairs, Pharmacovigilance and Translational Sciences. The role owns planning, operating rhythm, budget and resource tracking, cross-functional initiatives and executive reporting for Development. Most of the role's time supports Clinical Sciences & Operations, which carries the bulk of the organization's studies, vendors and spend, working closely with the VP, Clinical Operations & Clinical Sciences.
DUTIES AND RESPONSIBILITIES:
Run the Development annual goals, operating plan and long-range planning cycle with the Head of Development and functional heads.
Translate corporate and pipeline priorities into functional plans, resourcing and budgets; track delivery against goals.
Prepare executive, leadership-team and board materials on the Development portfolio, progress and risks.
Run the Development leadership cadence: leadership team meetings, portfolio and program reviews, decision and action logs.
Coordinate cross-functional governance and interfaces across Clinical Development, Clinical Sciences & Operations, Medical Affairs, Pharmacovigilance and Translational Sciences.
Program-manage cross-functional initiatives (e.g. inspection readiness, systems implementations, process harmonization) with plans, owners and status.
Maintain the portfolio view of all studies: milestones, enrollment, risks and spend, with dashboards drawn from CTMS and vendor data.
Coordinate the budget cycle, monthly accruals and forecast reviews with Finance and study leads; track MSAs, work orders, change orders and invoices and flag variances.
Run the vendor governance calendar and support CRO and vendor performance reviews.
Program-manage functional initiatives such as vendor governance, RBQM rollout and CTMS/eTMF optimization.
Manage the inspection-readiness program: storyboards, readiness assessments, mock inspections and CAPA tracking.
Consolidate the Development budget and headcount plan with Finance and HR; track spend and hiring against plan.
Define and report Development KPIs and functional metrics.
Own the SOP and work-instruction lifecycle, training matrix and compliance tracking across Development functions, in partnership with Quality.
Coordinate administration and reporting for CTMS, eTMF and other Development systems with system owners and vendors.
Support hiring, onboarding, organizational design and team development programs across Development.
Other duties as assigned.
EDUCATION AND EXPERIENCE:
Bachelor's degree required; MBA, PMP or advanced scientific degree preferred.
10+ years in biopharma, including 5+ years in clinical operations, development program management or R&D business operations at a sponsor.
Cross-functional exposure to clinical development, medical affairs and pharmacovigilance; small-biotech experience valued.
Experience with clinical budgets, accruals, vendor contracts and R&D planning cycles.
Strong portfolio reporting (CTMS, Excel/BI tools) and executive- and board-ready communication.
Working knowledge of GCP, GVP, SOP management and inspection readiness.
DESIRED KEY COMPETENCIES:
Self-organizer, highly motivated, and keen attention to detail.
Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
Ability to understand and execute the company's mission and values.
Maintain a high degree of ethical standard and trustworthiness.
Exhibits an open mindset when approaching challenges and conflict.
Ability to think and adapt to a rapidly changing environment and demands.
Strong time management and organizational skills.
Ability to manage multiple projects in a fast-paced environment.
