Trial Delivery Management (Base) Job at iconplc (Blue Bell)

Trial Delivery Management (Base) - Immunology

As a Trial Delivery Management (Base) at ICON, you will be responsible for leadi...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in project management, business, or a related field is preferred, with significant experience in project management and team leadership
Proven track record of successfully managing projects from inception to completion, with a focus on delivering results within scope, time, and budget constraints
Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks
Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations
Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous
Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement
Willingness to travel as required (approximately 30%)

Job Responsibility

Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery
Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration
Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track
Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives
Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Director, Quality Assurance

Theradaptive is revolutionizing the field of therapeutic delivery with a pipelin...

Location

United States , Frederick

Salary:

Not provided

Theradaptive

Expiration Date

Until further notice

Requirements

Bachelor's degree (required) in Life Sciences, Biomedical Engineering, Chemistry, Biochemistry, or a related field
Advanced degree (M.S., Ph.D., or M.D.) strongly preferred
15+ years of progressive quality experience in the biopharmaceutical, biotech, or medtech industry, with at least 5 years in a senior leadership role (Director level or above)
Demonstrated experience with combination products, including working knowledge of both drug/biologic and device QMS frameworks
Direct experience managing FDA inspections (PAI, cGMP, QSR) and responding to 483 observations and Warning Letters
Hands-on experience with protein biologics or growth factors (e.g., rhPDGF, BMP, FGF, EGF, VEGF) in a GMP manufacturing or quality context
Experience with sterile or aseptic combination products is highly preferred
Expert-level knowledge of: 21 CFR Parts 210/211 (Drug cGMP), 21 CFR Part 820 / ISO 13485 (Device QMS), 21 CFR Part 4 (Combination Products)
Expert-level knowledge of: ICH Q7, Q8, Q9, Q10, Q11 guidelines
Expert-level knowledge of: ISO 14971 (Risk Management), ISO 10993 (Biocompatibility)

Job Responsibility

Design, implement, and own an integrated QMS that satisfies 21 CFR Parts 210/211 (drug/biologic GMP), 21 CFR Part 820 / ISO 13485:2016 (medical device QMS), and ICH guidelines (Q7, Q8, Q9, Q10)
Ensure the QMS addresses the regulatory designation of the combination product (PMOA-based lead center: CDRH or CDER) and the requirements of the non-lead center
Develop and maintain all quality policies, SOPs, work instructions, and quality plans across the product lifecycle
Drive QMS digital transformation initiatives, including electronic quality management platforms (e.g., Veeva Vault QMS, MasterControl, TrackWise)
Serve as the company's subject-matter expert on 21 CFR Part 3 (combination product designation), 21 CFR Part 4 (regulation of combination products), and applicable guidance documents
Lead cross-functional efforts to align quality requirements for both the protein growth factor drug/biologic constituent and the device constituent part throughout CMC development, scale-up, and commercialization
Oversee the integration of device design controls (21 CFR 820.30) with drug development quality requirements, ensuring alignment in risk management activities per ISO 14971
Collaborate closely with Regulatory Affairs on BLA, PMA, 510(k), or De Novo submission strategies — specifically quality module content (Module 3 / CTD, Design History File, Device Master Record)
Prepare and lead quality-related FDA interactions including pre-submission meetings, Agency responses, and inspection readiness activities
Support compliance with EU MDR 2017/745, IVDR, and country-specific registration requirements for international expansion

New

Design Release Engineer- Instrument panel, floor console, or decorative trim systems

This role is categorized as hybrid. The selected candidate will be expected to w...

Location

United States , Warren

Salary:

Not provided

General Motors

Expiration Date

Until further notice

Requirements

Bachelor of Science in Engineering, such as Mechanical, Automotive, Aerospace, Materials, or a related field
8 to 10 years of experience in instrument panel, floor console, and decorative trim development with end-to-end exposure from early product definition through launch
Demonstrated track record of strong subsystem ownership, issue resolution, and on-time delivery to vehicle development milestones
Experience with injection molded trim, foam-in-place, thermoformed skins, and cut-and-sew wrapping of substrates
Detailed knowledge of instrument panel, instrument panel structure, and floor console performance requirements, regulations, and best practices
Proven experience in component and subsystem design and development, vehicle integration, and design for manufacturability and automation
Strong working knowledge of Design Failure Mode and Effects Analysis, Design Review Based on Failure Modes, validation plan development, Interface Control Documents, and Process Failure Mode and Effects Analysis in collaboration with Manufacturing Engineering
Demonstrated partnership with Computer-Aided Engineering teams, including Safety Performance, to validate robustness and inform design iterations
Design for Six Sigma Green Belt required
Demonstrated use of Design for Six Sigma tools to prevent defects and enable read-across

Job Responsibility

Lead the design, development, analysis, implementation, and validation of complex instrument panel and floor console subsystems
Perform engineering design evaluations and support concept development across vehicle programs
Use engineering tools such as Design Failure Mode and Effects Analysis, Interface Control Documents, and Process Failure Mode and Effects Analysis to develop robust system solutions
Partner with Computer-Aided Engineering teams, including Safety Performance, to validate designs and drive data-based design decisions
Assess designs for manufacturability, including processes such as injection molding, vibration welding, vacuum forming, foam-in-place, and wrapping
Package components and manage CAD development through suppliers or GM designers while ensuring best practices are incorporated into the models
Collaborate closely with adjacent vehicle systems, including thermal, electrical, body, chassis, and restraints
Schedule and lead peer reviews to evaluate designs with technical peers and resolve issues early
Support early vehicle configuration work, cost optimization, customer-driven requirements, and product and process improvements
Balance key business imperatives including cost, part count, mass, complexity, timing, and content

Fulltime

New

Medical Director, Pulmonary

Join the team transforming care for people with immune challenges, rare diseases...

Location

United States , Cambridge; Morristown

Salary:

206250.00 - 343750.00 USD / Year

Sanofi

Expiration Date

September 28, 2026

Requirements

Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, PA, NP or MD with relevant experience)
Minimum 5 years of relevant experience in Medical Affairs
Strong track record in developing and executing medical strategies in the US
Clinical or medical affairs experience in Pulmonary and/or Immunology strongly preferred
Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities
High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies
Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale
In-depth understanding of how to conceptualize, design, and conduct clinical trials. Experience in clinical trial design and execution preferred
Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities
ability to translate innovative strategies or solutions into actionable plans

Job Responsibility

Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned the respective therapeutic area products
Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables
Communicate the details and Progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution
Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans
Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of the respective therapeutic area products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities
Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development
Pro-actively provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, managing resources and budgets.

What we offer

High-quality healthcare
Prevention and wellness programs
At least 14 weeks gender-neutral parental leave

Fulltime

Rca Petcenter Manager F/M/X

The RCA Pet Center is a vital engine of Royal Canin’s global R&D ecosystem. We d...

Location

France , Aimargues

Salary:

Not provided

Mars

Expiration Date

Until further notice

Requirements

Leadership Excellence: Proven experience in people management with the ability to inspire a diverse operational team.
Operational Background: Experience in complex environments such as pet centers, laboratories, or high-tech manufacturing.
Scientific & Technical Literacy: A solid understanding of animal testing methodologies and the ability to oversee complex research protocols.
Project Management: Experience managing large-scale capital projects or facility modernizations (e.g., HVAC upgrades or technical center moves).
Communication: Native or Fluent French is essential for local authority interactions, with strong English for global collaboration within Mars Petcare.
Managerial Courage: The ability to challenge existing governance to foster a 'test and learn' culture.

Job Responsibility

Strategic Roadmap Execution: Define and lead the site’s evolution, aligning local operations with the broader R&D Facilities strategy and global innovation goals.
Agile Governance & Utilization: Optimize facility capacity by balancing long-term research with short-term 'innovation experiments,' small rapid studies, and startup collaborations.
Digital Transformation: Act as a key stakeholder in the shaping and deployment of digitalization initiatives towards operational efficiency, building system of a robust data backbone to link nutrition with health outcomes via AI and data.
Operational Excellence: Ensure the delivery of high-quality animal trial results and product prototypes while meeting safety, environmental, and budget targets.
Animal Welfare & Compliance: Serve as the primary liaison for French authorities, ensuring our site remains a gold standard for animal welfare and regulatory compliance.
Cross-Site Collaboration: Lead knowledge-exchange initiatives within Mars Ecosystem, global internal and external partners and Pet Centers to share best practices in governance and operational management and excellence.
Visitor Experience: Host over 4,000 annual visitors, showcasing our state-of-the-art campus and commitment to science-based nutrition.

What we offer

Global Impact: Work at the heart of Royal Canin's international HQ, a unique campus housing 800+ associates, two laboratories, and our flagship factory.
Innovation Culture: Join a team that is actively moving toward 'Second Brain' AI integration and cutting-edge longitudinal research.
Career Growth: Access world-class development through Mars University and opportunities for cross-functional moves within the global Mars Petcare ecosystem.
Purpose-Driven Work: Every day, you will contribute to our mission: A Better World for Pets.
Competitive Package: Industry-leading salary, benefits, and company bonus.

Fulltime

Clinical Research Associate II

We are seeking a Clinical Research Associate to join ICON Commercialisation & Ou...

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in Life Sciences, Nursing, Pharmacy, or Medicine
Significant experience as a Clinical Research Associate, ideally within late phase / Phase IV / real-world studies
Experience across both investigational product (IP) and medical device trials is highly desirable
Strong understanding of ICH-GCP, regulatory requirements, and post-marketing study environments
Proven ability to manage multiple sites and competing priorities
Expertise in site monitoring, data integrity, and risk-based monitoring approaches
Proficiency in clinical systems (e.g., CTMS, EDC)
Willingness to travel across the UK (~6–8 days per month)
Excellent communication, stakeholder management, and influencing skills

Job Responsibility

Conduct on-site and remote monitoring visits across late phase studies, ensuring compliance with protocols, ICH-GCP, regulatory requirements, and applicable device regulations
Support execution of post-authorisation, observational, and interventional studies, ensuring high-quality data collection and real-world evidence generation
Evaluate site performance, identify risks, and implement solutions to ensure studies are delivered on time and to quality standards
Partner with project teams, medical, data management, and commercial stakeholders to ensure efficient study delivery and reporting
Provide guidance and support to site personnel and junior CRAs, maintaining consistency and best practice across both device and IP trials
Build strong relationships with investigators and site staff to drive engagement and successful study execution

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Manager Regulatory Affairs CZ&SK

Senior Manager Regulatory Affairs CZ&SK. Czech Republic - Prague. SALARY RANGE: ...

Location

Czech Republic , Prague

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience
Degree and in-depth regulatory experience and/or related to the affiliate
Depth knowledge of affiliate legislation and regulations relating to medicinal products
English and Czech and/or Slovak language working proficiency
Good negotiation and Influencing skills
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
Cultural awareness and sensitivity to achieve results across both regional, affiliate and international borders
Ability to manage multiple activities and set priorities
Ability to lead teams and develop effective teams

Job Responsibility

Provides affiliate regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules
Oversee the affiliate and manage a regulatory team to ensure delivery of assigned local and ELMAC Regulatory initiatives
First point of contact for interactions with local regulatory agency(ies)
Ensure that the local Regulatory staff delivers assigned local and ELMAC Regulatory initiatives across the affiliates
Represent Regulatory on the affiliate leadership team
Provide local regulatory input to support development and execution of assigned Regulatory Affairs initiatives and effective interactions with key regulatory agency(ies)
Supervise and oversight for one or more regulatory staff
Manage and liaising with distributors (if applicable)
Translates assigned global, regional and ELMAC Regulatory initiatives into local regulatory objectives where applicable
Acts as senior point of contact for local regulatory advice on commercial and medical activities within the affiliate

Fulltime

Project Leadership – Biotech (clinical trials) – Oncology - Home Based

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Undergraduate degree in a clinical or health related field
advanced degree preferred
2+ years' experience leading Global Clinical Trials in Project Management within a CRO (preferred), Biotech or Pharma company
experience in project scheduling, managing resources and budgets and coordinating team activities
experience with the full clinical development process through regulatory submissions
additional years of experience required for more senior roles
flexibility
problem solving capabilities
strategic vision
detailed-oriented

Job Responsibility

Lead cross-functional teams to deliver high-quality and patient-focused clinical trials
collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
provide leadership to project teams and manage day-to-day operations
achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations

What we offer

Supportive work environment
high degree of empowerment and accountability to lead studies
flexible work arrangements (remote, in-office, hybrid)
career progression opportunities
varied project experience

Fulltime

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Trial Delivery Management (Base)

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