Program Director, Strategy & Operations

Precigen, Inc; Germantown (MD); On-site; USD 150,000 - 210,000; Full time

Job summary

Precigen, Inc. in Germantown, MD is seeking a Program Director, Strategy & Operations to lead the Development organization’s planning, budgeting, and executive reporting for Clinical Sciences & Operations, Clinical Development, Medical Affairs, Pharmacovigilance and Translational Sciences.

You will partner with the VP of Clinical Operations & Clinical Sciences to drive cross-functional initiatives, manage vendor relationships, and oversee governance, milestones, and KPIs across Development.

Qualifications

• 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.

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.

Skills

Clinical operations

Development program management

R&D planning cycles

Budget management

Executive communication

GCP/GVP/SOP knowledge

Education

Bachelor's degree

MBA or PMP or advanced scientific degree

Tools

CTMS

eTMF

Excel/BI tools

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Program Director, Strategy & Operations

Regulatory and Clinical Full-time Regular Germantown, MD, US

Salary Range: $150,000.00 To $210,000.00 Annually

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.Precigenis 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.