Jobs in the United States

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Engineer - Project Engineer
Federal Express Corporation
Remote, United States
- $4,881.62 USD / month
Participating in the development and implementation of operating plans, conducting studies, preparing data, and developing models and analytical tools for engineers and operations.
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IB-CHE/PMDT Developer- Remote opportunity
Serco
Jefferson City, MO
Serco-NA is seeking a motivated individual to serve as an IB-CHE/PMDT Developer in the Submarine Industrial Base Data Analytics Team , (IB-CHE: Industrial Base - Cloud Hosting Environment/…
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Sr Software Developer
Cherokee Federal
Chantilly, VA
Cherokee Preting is seeking a Software Developer to support our government client. The Software Developer will work with a large team of developers, software engineers, and data engineers.…
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Sr Software Developer
Cherokee Federal
Chantilly, VA
Cherokee Preting is seeking a Software Developer to support our government client. The Software Developer will work with a large team of developers, software engineers, and data engineers.…
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Software Developer - Expert
Cherokee Federal
Chantilly, VA
Cherokee Preting is seeking a Software Developer to support our government client. The Software Developer will work with a large team of developers, software engineers, and data engineers.…
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Software Developer - Expert
Cherokee Federal
Chantilly, VA
Cherokee Preting is seeking a Software Developer to support our government client. The Software Developer will work with a large team of developers, software engineers, and data engineers.…
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Associate Trade Sales Consultant
Pella Windows & Doors
Chicago, IL
- $25 USD / hour
…geography, as well as internal equity and alignment with market…
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HRIS Analyst III
D.R. Horton America's Builder
Arlington, TX
…standard reports for ongoing customer needs. Help maintain data integrity by running queries and analyzing…
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Principal Platform Engineer – Sales
Johnson & Johnson Services Inc. Legal Entity
Raritan, NJ · Horsham, PA · Cincinnati, OH
Do you thrive working with ambiguity and being able to shape industry-leading design patterns and world-class experiences? Are you ready to own the services that power all of our content &…
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Senior Manager, AI Architecture
Johnson & Johnson Services Inc. Legal Entity
Raritan, NJ
…into practical enterprise solutions. You may also lead the design and delivery of strategic AI platforms, accelerators and applications, particularly where architectural continuity and…
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National Manager, Professional Education - Biosurgery
Ethicon US LLC Legal Entity
Remote, United States
General Surgery Education: Design and execute education addressing bleeding management and Biosurgery applications within relevant open and minimally invasive General Surgery procedures.…
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WithMe CRM and Portal Data Lead
Johnson & Johnson HCS Inc. Legal Entity
Titusville, NJ
…business and patient-service needs, bringing together analysis and design inputs, and building a shared understanding of expected data outcomes with delivery…
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Sr. NPI Engineer - Johnson and Johnson MedTech, Circulatory Restoration
SHOCKWAVE MEDICAL INC. Legal Entity
Santa Clara, CA
…tooling, and fixtures throughout the product lifecycle, from design through production. This role will work closely with Production, Quality, and R&D teams to support the manufacturing…
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Senior Finance Director MedTech Surgery
Johnson & Johnson Services Inc. Legal Entity
Raritan, NJ
…surgery, orthopedics, vision, and interventional solutions to design healthcare solutions that are smarter, less invasive, and more personalized. The MedTech Surgery organization was…
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Postdoctoral Researcher – Advanced Material and Membrane Development for Water and Critical Mineral Recovery Applications
UChicago Argonne, LLC
Lemont, IL
…collaborators inside and outside Argonne. The candidate is expected to design and conduct experiments, analyze data and explore mechanisms behind the experimental observations, prepare…
Added 1 min ago
Staff NPI Engineer - Johnson and Johnson MedTech, Circulatory Restoration
SHOCKWAVE MEDICAL INC. Legal Entity
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…distill that understanding to crisply define the problem, and design and develop innovative solutions to address…
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Lead Systems Administrator
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Chicago, IL
The Lead Systems Administrator provides senior technical leadership for the strategy, design, implementation, operation, security, and continuous improvement of enterprise infrastructure…
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Project Architect
HOK
Denver, CO
…and healing the planet. Together, we cultivate a culture of design excellence at the confluence of art and science, blending the power of creative expression with a clear sense of…
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Manager, Communications - Integration & Operations
Sutter Health
Emeryville, CA
- $98,055.36 to $147,089.28 USD / year
Design and evolve the Communications operating model, including common ways of working for intake and prioritization, editorial planning, review and approval paths and status reporting, so…
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Senior Director, Business Development
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Minneapolis, MN
…comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement…
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Electrical Designer - Vista
Salas O'Brien
Vista, CA
- $28 to $35 USD / hour
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Staff MLE, GAI Search Platform - Moveworks
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RN Clinical Nurse Practice Specialist - OBV/MOU & Resource Teams
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Precigen, Inc

Program Director, Strategy & Operations

Germantown, MD, United States

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Job details

Education: Bachelor’s degree
Posting language: English

Original job description

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.

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More about this job

Skills

Reporting
Leadership
Inspection
Regulatory compliance
Onboarding
Team building
PMP
Program management
Microsoft Excel
Communication skills
Google Cloud
Attention to detail
Time management
Organizational skills

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