Associate Director - Global Clinical Program Management Job at Amgen (Cambridge)

Associate Director Global Clinical Program Management

In this vital role you will lead the operational delivery of complex clinical pr...

Location

United States

Salary:

182145.00 - 212860.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of clinical execution experience
Master’s degree and 7 years of clinical execution experience
Bachelor’s degree and 9 years of clinical execution experience
Associate’s degree and 12 years of clinical execution experience
High school diploma / GED and 14 years of clinical execution experience
Minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead the operational planning and delivery of multiple clinical studies or programs, ensuring timelines, budget, quality, and strategy are met
Proactively identify delivery risks and guide course-correction to keep studies on track
Drive consistent, high-quality operational practices across all assigned studies and programs
Line-manage and develop Study Delivery Leads, setting clear objectives and fostering high performance
Oversee program-level issues, risks, and escalation, ensuring timely and effective resolution
Partner cross-functionally and with local execution teams to align priorities, resources, and delivery plans
Provide strategic input on study design, country selection, enrolment, diversity, and patient-centric approaches
Manage program-level budgets, vendors, and forecasting while embedding lessons learned and continuous improvement

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

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Associate Director, Clinical Data Manager

Associate Director, Clinical Data Manager (Sponsor Dedicated). ICON plc is a wor...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in Data Science, Statistics, Bioinformatics, or a related field
Experience in all aspects of Data Management related clinical study planning and execution, and in executing the complete range of clinical study activities, from concept sheet through final study report and archiving
Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to at least 10 years
Substantial project management experience
Strong leadership competencies and influencing skills
Effective oral and written communication skills
Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams
Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
Successful completion of multiple studies from beginning to end providing a full scope of DM experience

Job Responsibility

Leading Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity
Serving as the escalation point, work with CRO data managers, vendors, internal team members for resolution
Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) and submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
Project management of all clinical data management related deliverables including operationalization by steering internal and external experts and specialist. Ensuring adherence to planned time, cost and quality
Execution of the clinical data collection strategy in accordance to Sponsor Standards
Accountable for oversight of CROs in the execution of Phase I – IV clinical trial(s)
Represents Data Management within the Global Trial Team and serves as the key Global Development Operations point of contact for the DM related tasks in a trial/project/program
Key contributor to the development of reports and communicating to relevant line management and Clinical Operations Teams
Drives, leads and manages the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials using strong project management, leadership, and organizational skills
Ensures strong oversight, review and delivery of trial/project DM related CAPAs in order to meet corporate compliance standards and timelines

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

Associate Director, Epidemiology (Global Health)

Location

United States , Collegeville

Salary:

129000.00 - 179000.00 CAD / Year

GSK

Expiration Date

Until further notice

Requirements

Master’s degree in Epidemiology, Public Health, Biostatistics, or a related quantitative discipline
Epidemiological experience and ability to influence key internal (matrix leaders) and external (e.g. regulators) stakeholders
Experience applying epidemiologic methods in pharmacoepidemiology, clinical development, or outcomes research
Experience designing and delivering observational and database studies, including protocol development and analysis oversight
Experience working in a matrix environment and influencing multidisciplinary teams
Experience providing the delivery of increasingly complex epidemiological studies, including regulatory requirements
Experience applying epidemiology methods and study design knowledge in execution of their work (e.g. post-approval studies)
Experience working with external regulatory requirements and scientific landscape around RWE

Job Responsibility

Accountable for the epidemiology program for at least one asset or disease area, including proposing and negotiating program content and budget with matrix leaders
Provide expert epidemiological insights to asset matrix teams (e.g., Clinical Development Team, Safety Review Team, Medicine/Vaccine Development Team)
Lead complex epidemiological studies and negotiate new partnerships with oversight from senior staff
Identify new vendors, tools, and data sources to deliver innovative epidemiology solutions for assets or disease areas
Contribute to strategic initiatives on the role of epidemiology at the departmental or R&D level
Represent GSK in scientific interactions with internal governance bodies, external regulators, and at international conferences
Plan and coordinate scientific dissemination of epidemiology data, including authoring regulatory documents, peer-reviewed publications, and presentations at national and international meetings
Partner with external groups conducting epidemiological studies globally and manage external collaborations

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Brazil Country Head, Global Site & Study Operations Associate Director

Provide strategic and operational leadership for all study and site execution wi...

Location

Brazil , São Paulo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of clinical execution experience
Master’s degree and 7 years of clinical execution experience
Bachelor’s degree and 9 years of clinical execution experience
At least 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
+8 years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience
Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
Advanced English proficiency

Job Responsibility

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography
Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography
Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection
Lead, line-manage, and develop the Country/Hub team
Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles
Drive site engagement through a clearly differentiated Amgen site experience
Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight
Lead country governance and risk management, including chairing the Country Management Team (CMT)
Ensure regulatory compliance, inspection readiness, and continuous improvement

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

Regulatory Affair Director - Global Regulatory Leader (Rare Disease)

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States

Salary:

189632.45 - 256561.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly related experience
Master's degree and 8 years of directly related experience
Bachelor's degree and 10 years of directly related experience
at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan
Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling
Provides regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
Leads development, review and approval of the target product label (TPL)
Obtains input from the GRT members (e.g. RRLs, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance
Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents)
Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions
Monitors and assess impact of relevant global regulations, guidances, and current regulatory environment
Ensures guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy

What we offer

A 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
Flexible work models where possible

Fulltime

Associate Director, Product Quality Assurance

The Associate Director of Product Quality for Cell and Gene Therapy Programs wil...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in scientific discipline
12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements
Ability to influence without direct authority
Ability to develop into a primary PQL for Beam programs
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Excellent listening, communication and interpersonal skills fostering team spirit

Job Responsibility

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments
Drives and takes action on Phase Appropriate Quality strategy for Beam’s products
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL
Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives
Support clinical to commercial analytical control strategy
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.)
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations

Fulltime

Associate Director, Biostatistical Programming

How might you defy imagination? If you feel like you're part of something bigger...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 16 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage a large team of programmers in successful and timely completion of all programming activities for highly complex studies and regulatory submissions
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, and others) or R
Prior regulatory submission experience for approval
Thorough understanding and experience with data quality and compliance checks
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Prior staff development leadership and project management experience

Job Responsibility

Partner with Global Programming Leads (GPL) and lead a large offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large, high priority products or indications across products
Accountable and responsible for Global Statistical Programming study results and submission activities for the assigned products or indications across products
Contribute at the department level by leading major GSP technical or operational efficiency initiatives and ensuring compliance with R&D standards
Lead or serve as a member of GSP and cross functional consultancy groups such as Submission Consultancy Group and ADaM Consultancy Group
Drive the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency across the organization

Fulltime

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Associate Director - Global Clinical Program Management

Job Description

Job Responsibility

Requirements

What we offer

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