Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
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.
