Biotech Project Leadership - Clinical Trials Job at Parexel

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

New

Biotech Project Leadership - Clinical Trials

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

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Undergraduate degree in a clinical or health related field (advanced degree preferred)
Minimum 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 and strategic vision
Detailed-oriented, computer proficient and possess superior interpersonal and organizational skills

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 the day-to-day operations
Achieve operational excellence through on time delivery within budget and to the highest quality

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
Flexible work arrangements (remote, in-office and hybrid roles)
Career progression opportunities
Supportive and inclusive environment

Fulltime

Clinical Trial Oversight Manager

Do more with the knowledge you’re working hard to acquire and the passion you al...

Location

Italy , Milan

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree OR Doctorate degree OR BA/BS/BSc or qualified nurse (RN)
Work experience in life sciences or medically related field, including Biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience as a CRA, CTA, and/or Clinical/Regional Manager in the biopharmaceutical industry
Experience in a project leadership role
Experience working with or for Functional Service Provider or Contract Research Organizations
Supervisory Experience
Knowledge of or work experience with a biopharmaceutical GRDCA or QC department
Familiarity with advanced concepts of clinical research, extensive knowledge of ICH/GCP regulations and guidelines, strong knowledge of clinical trial operations, and understanding of Functional Service Provider operational model
Computer and system operation skills

Job Responsibility

Perform sponsor oversight activities of SM-FSP, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen clinical trials
Collaborate closely with SM-FSP Line Manager (FSPLM) to ensure appropriate level of their staff oversight is deployed
Support SM-FSP staff onboarding and training
Be a point of escalation for all stakeholders to support resolution of issues on quality, staff turnover and performance concerns
Work with SM-FSP vendor(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out
Conduct on-site quality visits with CRAs where/when appropriate and supports the maintenance of Amgen investigator site relationships
Support inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution
Organize and lead the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable
Be involved in local and global site management and cross functional stakeholder collaboration
Actively participate in role forums including local and global functional and cross-functional initiatives

What we offer

Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Project leader

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

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Undergraduate degree in a clinical or health related field (advanced degree preferred)
Minimum 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 and strategic vision
Detailed-oriented, computer proficient and possess superior interpersonal and organizational skills

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 the day-to-day operations
Achieve operational excellence through on time delivery within budget and to the highest quality

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
Flexible work arrangements (remote, in-office and hybrid roles)
Career progression opportunities

Executive Director, Global Clinical Operations

We are seeking an Executive Director, Global Clinical Operations, (GCO), who wil...

Location

United States

Salary:

285000.00 - 320000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
Minimum 20 years of clinical research experience, including at least 5 years leading global projects from inception to completion
Minimum of 7 years line management experience
Minimum of 3 years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, etc.
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally
Excellent communication skills with ability to develop strong relationships and present to a variety of stakeholders and tailor message accordingly
Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally

Job Responsibility

Manage and plan CTO resourcing for assigned programs
Lead, build and mentor CTO team supporting assigned program(s)
Serve as a member on Clinical Operations Leadership Team (COLT)
Create and support implementation of Clinical Operations processes, platforms and/or systems
Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs
Clinical operations representative on Program Teams (PT)
Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans
Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
Strong collaboration and partnership with cross functional colleagues globally

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

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

Study Start-up Manager

Drive the planning and execution of clinical study start-up activities, ensuring...

Location

United States

Salary:

122229.00 - 150449.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Pharma and clinical trial processes and operations expertise
Experience leading and managing global teams
Project management experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
Doctorate degree OR Master’s degree and 3 years of clinical execution experience OR Bachelor’s degree and 5 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR High school diploma / GED and 12 years of clinical execution experience

Job Responsibility

Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met
Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track
Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration
Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start
Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed
Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution
Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities
Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub

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

Biotech Project Leadership - Clinical Trials

Parexel

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 04, 2026

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