Integration Delivery Director- Clinical Job at Advocate Health Care (Milwaukee)

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Interim Chief Medical Officer

The Interim Chief Medical Officer (CMO) serves as the organisation’s most senior...

Location

United Kingdom , Welwyn Garden City

Salary:

109725.00 - 145478.00 GBP / Year

Remedium Partners

Expiration Date

Until further notice

Requirements

GMC registration with a licence to practise (GP or Specialist Register)
Minimum 1 year of NHS experience
Level 4 Safeguarding Training
Postgraduate medical qualification (e.g. MRCGP, MRCS)
Inclusion on the NHS England Performers List (GP route)
Evidence of ongoing professional and leadership development
Significant leadership experience at Medical Director, CMO, or equivalent senior clinical leadership level
Comprehensive experience in urgent care, primary care, NHS 111, out-of-hours, or unscheduled care
Proven organisational-level experience of clinical governance, safety, and quality improvement
Strong influencing, communication, and stakeholder engagement skills

Job Responsibility

Provide comprehensive reporting to the Board on clinical performance, safety, risks, and improvement initiatives
Hold organisational accountability for clinical safety and quality across all services
Lead the development of clinical policies, innovation proposals, and integration strategies for Board approval
Oversee serious incidents, complaints, and professional concerns, ensuring learning is effectively embedded
Produce and assure key governance outputs, including monthly board reports, annual quality accounts, audits, and evidence for regulatory compliance
Lead compliance with statutory, regulatory and professional standards across all services
Serve as the senior accountable clinical leader for all services within the organisation
Provide visible, inspirational leadership to the Senior Leadership Team and the wider clinical workforce
Deliver appraisal, performance management, and strategic oversight of clinical teams
Ensure compliance with organisational values, objectives, NHS standards, and regulatory requirements

Fulltime

Global Development Transformation Director

In this vital role as Development Transformation Director you will serve as a st...

Location

United States

Salary:

188957.00 - 226073.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 5 years of transformation initiative experience
Masters degree & 6 years of transformation initiative experience
Bachelors degree & 8 years of transformation initiative experience
5 years of managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources

Job Responsibility

Lead and support the implementation of global development transformation initiatives
Identify inefficiencies and recommend sustainable Clinical Trial solutions to improve operational performance
Ensure integration of transformation efforts with technological advancements and digital tools
Collaborate with cross-functional teams to ensure alignment and address interdependence
Monitor progress and develop KPIs and assess the impact of transformation initiatives
Proactively identify and mitigate risks to project success
Conduct project scoping and chartering, define implementation strategy, and guide project completion
Accountable for measuring and demonstrating tangible business impact of solutions and analyzing data to assess ROI and making continuous data-driven decisions to maximize value creation
Accountable for communication internally and externally to Amgen leadership and governance regarding project status, milestones, risks and value capture
Instill and maintain a culture of performance, continuous improvement, and diversity, inclusion, and belonging

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

Clinical Scientist Director – Early Development, Oncology

In this vital role, the Clinical Scientist Director will support early phase cli...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience
5 years of pharmaceutical clinical drug development experience
Industry or academic experience in early-phase drug development within Oncology
Strong communication & presentation skills in English
Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, database lock, data extract, producing outputs of data
Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
Serving as a contributing author to scientific publications and data presentations at scientific conferences

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Clinical Scientist Director – Early Development, Oncology

In this vital role, the Clinical Scientist Director will support early phase cli...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience
5 years of pharmaceutical clinical drug development experience
Industry or academic experience in early-phase drug development within Oncology
Strong communication & presentation skills in English
Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, database lock, data extract, producing outputs of data
Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
Serving as a contributing author to scientific publications and data presentations at scientific conferences

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Clinical Scientist Director - Late Development, Rare Disease

In this vital role, the Clinical Scientist Director will support late-phase clin...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience
5 years of pharmaceutical clinical drug development experience
Strong preference for individuals with proven track record of clinical trial process improvement
Industry or academic experience in late-phase drug development for the Rare Disease therapeutic area
Strong communication & presentation skills in English
Experience with designing, monitoring, and implementing clinical trials for the Rare Disease therapeutic area and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross-functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Clinical Scientist Director - Late Development, Rare Disease/Inflammation

In this vital role, the Clinical Scientist Director will support late-phase clin...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of life sciences/healthcare experience
Master’s degree and 7 years of life sciences/healthcare experience
Bachelor’s degree and 9 years of life sciences/healthcare experience
5 years of pharmaceutical clinical drug development experience
Strong preference for individuals with proven track record of clinical trial process improvement
Industry or academic experience in late-phase drug development for the Rare Disease therapeutic area
Strong communication & presentation skills in English to clearly communicate scientific concepts/data to leadership committees both internally or externally (both written and oral)
Experience with designing, monitoring, and implementing clinical trials for the Rare Disease therapeutic area and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions

Job Responsibility

Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity
Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues
Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
Work cross-functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents
Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval
Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results
Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements
Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements