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

New

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

Global Clinical Trial Lead/Senior Clinical Trial Manager

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

Location

Germany

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s degree and minimum 6 years of relevant global trial management experience
Experience in early phase Oncology or Immunology is essential
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies
Effective communication skills via verbal, written and presentation abilities

Job Responsibility

Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s
Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Varied project experience
Career progression

Executive Director, Medicine Development Leader

GSK is seeking a highly skilled Executive Director, Medicine Development Leader ...

Location

United States; United Kingdom , Waltham; London; Stevenage; Collegeville

Salary:

242250.00 - 403750.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree including MD, PhD, PharmD, MBA, MS
Drug development expertise in the global pharmaceutical/biotechnology industry
Filing experience with BLA/NDA/MAA submissions as a core responsibility
Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical and Commercial
Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
Experience building budgets and leading the strategic and budget planning process
Experience the healthcare environment, and access in all major markets

Job Responsibility

Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from proof of clinical activity (POC) to Approval in all major market(s)
Work closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
Work with the functional line Heads supporting RIIRU to select MDT members and lead this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
Leads the cross-functional MDT to: Establish a compelling vision for the medicine and Target Medicine Profile (TMP) which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK’s strategy into asset strategy and actionable plans for multiple areas or functions
Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product’s life cycle
Prioritize and maximize the asset’s development options including developing multiple indications
Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

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

New

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

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Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:December 28, 2025

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