Global Trial Manager - Early Development Job at iconplc (CARY, BLUE BELL, RAHWAY, NJ)

Global Development Product Lead

Leads multiple cross functional oncology product teams from pre-clinical candida...

Location

United States , La Jolla; Cambridge; Bothell; South San Francisco; New York City

Salary:

295900.00 - 478800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

MD or MD-PhD with 10+ years of industry experience in oncology drug development is preferred, track record in oncology clinical research including early phase drug development
Clinical oncology experience: Board certification in oncology preferred
Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development
Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Demonstrated scientific productivity (publications, abstracts, etc.)
Proven scientific writing skills and good communication skills
Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
Capacity to adapt to a fast-paced and changing environment
Demonstrated history of effective leadership
including cross functional and matrixed teams, managing direct reports when applicable, and experience in seeking and maintaining alignment with cross-functional leaders

Job Responsibility

Leads multiple (~2-4) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages
In close collaboration with functional experts on the product teams, drives the effective integration of an end-to-end cross functional molecule strategy and risk mitigation plan and ensures delivery of data-driven milestones through successful risk identification and mitigation
Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community
Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
To ensure the cross-functional components of the product plans including clinical expertise are provided to project teams, including medical monitoring of clinical trials
Substantial support of CDP development and diligence for external innovation activities
Lead key enterprise level cross-functional workstreams to accelerate R&D decision making
Lead, develop and execute strategic development for early development assets
Ensure timely execution and delivery of product milestones within budget
Communicate with executive management and governance committees to address program needs and provide recommendations

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Site Investigational Product Specialist

As a Site Investigational Product Specialist you will be joining the world’s lar...

Location

United Kingdom , Reading

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A degree in general nursing is required
3- 4 years of recent clinical/hospital experience is required
Experience in antibody treatment, (Oncology (hematology and solid tumor) and / or Immunology Therapeutic Area)
Min. 3 years’ experience with various IP administration routes (IV, SC, IM)
Clinical trial research experience
Minimum of 5+ years of recent clinical/hospital experience is required
Minimum of 5+ years’ experience with various IP administration routes (IV, SC, IM, intravesical, intraperitoneal, blood- and cell products) and priming and flushing procedures required
Extensive knowledge on Administration related requirements (background of anatomy and physiology, metabolism of drugs and IP, hygienic requirements, how to handle hazardous drugs)

Job Responsibility

Play a key role in the safe, efficient and effective Investigational Product preparation and administration in clinical trials
Review and provide input on Investigational Product Preparation Instructions Site Investigational Product Procedures Manual, monitoring guidelines and all specific forms related to Investigational Product preparation and dosing before finalization as applicable
Process risk assessment review where applicable
Close collaboration with the Drug Product Development team and the Drug Preparation Administration Team
Early connection with investigational site pharmacy and nursing staff to review site IP process and equipment
Close collaboration with (Global Trial Lead) GTL, (Study Manager) SM, (Trial Manager) TM, Independent Drug Monitor (IDM) and Pharmacy Investigational Product Specialist (PIPS) for all IPPI related topics
Evaluate and support process for IP ancillary supplies/administration kits are compatible with the site equipment/practice in the country/investigational site
Review of site's dispensing and accountability records to ensure key information is captured to confirm dose delivery and administration is documented e.g. infusion rates/volumes
Collaboration on Investigational Product training material development with key stakeholders
Observe first dosing on site and/or support SM/IDM/PIPS if allowed according to local guidelines and blinding requirements

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

Executive Director, Study Start-Up

In this vital role as Executive Director, Study Start-Up (SSU), you will lead SS...

Location

United States , Thousand Oaks

Salary:

281634.00 - 336501.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of clinical execution experience
Master’s degree and 10 years of clinical execution experience
Bachelor’s degree and 12 years of clinical execution experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
12+ years’ work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making
ability to escalate and resolve challenges in alignment with global study strategy priorities
Extensive knowledge of the clinical and pharmaceutical drug development process, from early to late-stage development with a deep understanding of relevant therapeutic areas to meet the highest scientific and regulatory standards

Job Responsibility

Shape the long-term vision and strategy of the SSU Hub, ensuring alignment with CPSO, GDO, and enterprise priorities
Integrate and harmonize strategies from the six sub-functions into a single global capability strategy, balancing standardization with local/regional adaptability
Act as the global escalation point for study start-up risks and issues, ensuring timely resolution and portfolio-level visibility
Embed within the industry - bringing outside ways of working and representing Amgen back into the industry
Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence
Lead, and mentor the global SSU Hub leadership team, ensuring robust succession planning, talent development, and organizational effectiveness
Drive consistent performance management, alignment, and calibration across sub-functions to ensure equitable resourcing and delivery
Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally
Oversee start-up planning and execution across all new studies globally, ensuring timelines and quality standards are consistently achieved
Partner with Clinical Program Strategy and Operations TA Heads to ensure seamless integration of start-up into program execution

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Lung cancer MAS team lead

Acts as a line manager leading a team of MAS. Shapes the local strategy and ensu...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Minimum requirement: 4-year university undergraduate degree AND master’s degree in life science, or Pharmacists >4-year university graduates with pharmacist license and master’s degree or equivalent life science research experience, or >6–year university graduates with pharmacist license, or Nurses with a master’s degree, or Veterinarians, or Dentists, or MDs
Preferred: MD (clinical experience, board certification preferred), or PhD in Life Science
Experience in the pharmaceutical industry, preferably as a Medical/Scientific Advisor, MSL, team lead, and/or clinical experience with direct patient care and/or professional experience in the pharmaceutical industry in relevant areas
MA/DJ experience and / or research experience preferred
Scientific publication
Strategic Thinking: Ability to consider the direction of Medical from a mid-to-long-term perspective and formulate strategies as a manager at Pfizer
Communication Skills: Ability to conduct clear and efficient communication, including with other departments, and convey information accurately and logically
Decision-Making Ability: Ability and responsibility to make quick and effective decisions even in situations where there is no clear answer
Leadership: Ability to influence teams and departments and drive them towards achieving organizational goals
Financial Skills: Ability to manage budgets and execute actions reliably and on schedule

Job Responsibility

Acts as a line manager leading a team of MAS
Shapes the local strategy and ensures the delivery of scientific-medical expertise and exchange with KOLs in the assigned therapeutic area
Lead the Pfizer Japan medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders
Play a central role as a scientific and medical leader who can identify unmet medical needs(UMRs), drive the building and executing medical plans and oversee establishment of clinical evidence
Demonstrate medical and scientific leadership and expertise
Ensure and oversee the highest scientific standards during in / external activities to provide deep medical and scientific expertise
Lead development of local medical plan aligned with global medical plan to address local UMRs and fill data gaps, and manage implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines
Direct and supervise providing and exchanging medical/scientific information for/from medical facilities in the assigned area and external stakeholders and make strategic decisions on medical strategies for assigned products
Drive and monitor heightened understanding of the burden of disease in the assigned therapeutic area and medical attributes of our products to enhance the safe and efficacious use
Lead achievement of department/team goals, and/or manage cross-organizational projects, providing guidance and accountability for results

Fulltime

Study Physician - Oncology - FSP

The Study Physician (SP) is a critical global role that is created to take up me...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style
Pronounced presentation and training skills
Capability to work proactively and with team spirit in an international environment
Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

Clinical Study Physician - Oncology - FSP

Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is ...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Physician MD, ideally with medical thesis, trained in a clinical setting
Minimum of 4 years of active clinical experience
specialization in internal medicine or general practice preferred
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems
Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

What we offer

Flexible approach to work that meets your personal needs while maintaining quality delivery for patients
Choose the right work arrangement for you - in-office, home-based or a mix
Benefits vary by country, but Parexel is passionate about our team’s overall wellness
Investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career

Fulltime

Global Senior Employment Litigation Counsel

The Senior Employment Litigation Counsel is responsible for strategic oversight ...

Location

United States , Austin

Salary:

192960.00 - 289440.00 USD / Year

AMD

Expiration Date

Until further notice

Requirements

Juris Doctor (JD) or equivalent law degree from an accredited institution
Active bar membership in at least one jurisdiction
Demonstrated experience managing complex, multi‑jurisdictional employment litigation
Strong knowledge of U.S. employment litigation
Experience with international employment disputes strongly preferred
Experience supporting a global workforce across multiple regions (e.g., Americas, EMEA, APAC)
In‑house experience
Prior responsibility for litigation budgeting and outside counsel management at scale
Familiarity with alternative dispute resolution mechanisms internationally
Exceptional legal judgment and strategic thinking

Job Responsibility

Lead and manage all employment‑related litigation, attorney demands and administrative proceedings globally
Develop and execute global employment litigation strategy
Oversee case assessment, early resolution strategies, discovery, trial preparation, and settlement negotiations
Select, retain, and manage outside counsel across multiple jurisdictions
Control litigation budgets, monitor spending, and drive cost‑effective outcomes
Ensure external counsel aligns with company values, principles, and litigation strategy
Partner closely with HR, Ops/Finance and regional Legal teams to proactively manage employment risk
Advise senior leadership and HR stakeholders on litigation exposure, trends, and risk mitigation strategies
Identify systemic litigation risks and recommend process improvements, training, and policy updates
Analyze and report litigation data and trends

Fulltime

Executive Director, Research & Development Quality Assurance

Joining Moderna offers the unique opportunity to be part of a pioneering team th...

Location

United States , Cambridge; Bethesda

Salary:

224900.00 - 404600.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Bachelor's degree in a life science or related field
advanced degree preferred
15+ years of progressive experience in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials, regulatory submissions, laboratories and PV and clinical safety
10+ years' experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals
Expertise to oversee comprehensive resource and staffing management, building high-performing teams and fostering a culture of continuous improvement and accountability
Experience in the development and execution of robust audit schedules, coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration
Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines, including ICH E2 and EU PV legislation
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH regulations, guidance and local legislation for clinical trials, including a ICH E6 (R3)
Proven ability to collaborate and influence in a fast-paced, matrixed environment

Job Responsibility

Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna's entire development portfolio
Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna's innovation agenda
Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas
Embed risk-based quality management principles into study design, data generation, and vendor oversight practices
Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA, EMA, MHRA), ensuring timely and effective resolution of findings
Drive modernization of vendor oversight and shared accountability models, elevating external partnership performance
Build and lead a high-performing, solutions-oriented R&D QA team, rooted in scientific credibility and operational excellence
Enhance Quality Culture across R&D by promoting real-time quality management, early issue detection, and continuous feedback loops
Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance
Own the end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

Global Trial Manager - Early Development

iconplc

Location:
United States , CARY, BLUE BELL, RAHWAY, NJ

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 28, 2025

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Our AI answers in your language

Global Trial Manager - Early Development

iconplc

Location:United States , CARY, BLUE BELL, RAHWAY, NJ

Category:IT - Administration

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:December 28, 2025

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Job Posted:
December 28, 2025