Associate Director, Global Medical Publications Job at The Muse

Associate Director, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Director, Medical Affairs

As the Associate Director, UCAN Medical Affairs, you will play a pivotal leaders...

Location

United States , Deerfield

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced healthcare degree with 10+ years of clinical experience
Background in ICU, Med-Surg, or Clinical Informatics strongly preferred
Prior Medical Affairs experience highly desirable
Proven experience within the healthcare or life sciences industry
Strong leadership, interpersonal, analytical, and problem-solving skills
Clinical trial experience with a solid understanding of Good Clinical Practice (GCP)
Working knowledge of biostatistics and clinical trial design
Strong digital fluency, including advanced PowerPoint capabilities
Expertise in literature review, synthesis, and scientific analysis
Confidence and effectiveness in public speaking and scientific presentations

Job Responsibility

Provide regional Medical Affairs leadership for new product development, ensuring scientific rigor and clinical relevance
Identify evidence-generation gaps and drive regional evidence strategies in collaboration with Global Business Unit (GBU) Medical Affairs teams
Develop and execute scientific communication and non-promotional education (NPE) plans aligned with product and portfolio strategy
Design, lead, and support advisory boards, clinical investigator meetings, roundtables, and scientific forums
Partner with cross-functional stakeholders to shape long-term Medical Affairs strategies, including comprehensive thought leader engagement plans
Represent Medical Affairs at regional, national, and international medical congresses, providing scientific support and translating emerging data into actionable insights
Monitor and communicate scientific trends, opportunities, and risks that may impact the business
Maintain strong alignment with Global Medical Affairs, ensuring collaboration across data generation, clinical trials, publications, advisory boards, CMEs, and literature strategy
Oversee Grants and Sponsorships, ensuring compliance, accurate documentation, and timely execution
Ensure strict adherence to all internal, legal, regulatory, and compliance standards

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Medical Director, Global Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field
At least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

Clinical Scientist Associate Director

In this role, the Clinical Scientist Associate Director supports the design, exe...

Location

Spain

Salary:

90787.65 - 122830.35 EUR / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience

Job Responsibility

Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards
Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments
Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring
Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions
Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable
Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites
Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts
Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees
Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies
Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders

Fulltime

Director, Global Content Design and Delivery, Oncology

The Director, Global Content Design and Delivery, Oncology in the Global Scienti...

Location

United States; Switzerland; United Kingdom , Collegeville; Baar; Durham; London; Philadelphia; Upper Providence

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Advanced degree in science, medicine, pharmacy, communications or a related field
7+ years of related experience in scientific communications, medical content design and delivery, or a related field within the pharmaceutical or healthcare industry
Experience in leading cross-functional teams and driving strategic communication plans
Mastery developing and executing innovative communication tools, including digital and social media strategies
Project management expertise with multiple projects simultaneously, meeting deadlines
Experience in developing and delivering medical training materials
Proficiency in digital content creation and management tools with solid technical capabilities in Excel, PowerPoint, and Team sites
Interpreting, analyzing, organizing, and presenting complex data to a broad range of audiences required

Job Responsibility

Chair the Global Integrated Medical Communication Teams (GIMCT) for assigned assets/therapeutic areas to drive the development of Integrated Medical Communication Plans (IMCP), inclusive of content, channel, and congress plans/tactics
Drive key asset deliverables including the Scientific Communication Platform (SCP), Scientific Narratives, Content and Channel plans, Congress Plans and all associated tactics
Serve as a key partner to therapeutic area medical leaders, global publications, R&D, Global Medical Team (GMT), and priority markets and regions
Collaborate with internal stakeholders on the development and execution of innovative tools for internal and external communication, including digital/social medical delivery
Drive timely execution of all deliverables within the IMCPs for assigned assets, ensuring they are scientifically accurate, evidence-based, and comply with relevant regulations, industry guidelines, and ethical standards
Accountable for aligning with key stakeholders and for the input of the IMCP framework and related engagement planning elements within the asset annual business planning process
Lead annual scope of work development with procurement for IMCP deliverables with agencies of record, and provide continuous oversight and feedback to drive effective collaboration and partnership
Ensure content development follows all relevant codes and system requirements (e.g. ABPI code of practice, GSK Code, and use of Content Lab), particularly with respect to the delivery of promotional versus non-promotional information
Participate in initiatives on Gen AI platforms being leveraged for content creation and personalization/adaptation to ensure broader scalability and use
Gather and share best practices across Global to ensure consistency, high standards, and excellence are maintained across the organization

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

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment
Ability to multitask priorities to align with program objectives

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

Senior Director, Head of Argentina Clinical Data Sciences

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit wit...

Location

Argentina , Buenos Aires

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree. Advanced degree preferred
Ideally 20 or more years’ experience in drug development with at least 10 years in Clinical Data Management
At least 10 years' line management or global project team leadership experience
Clinical development and business experience in order to have a thorough understanding of regulatory processes at a global level
Recognition in peer community as expert and leader in topic area
Ability to leverage network to establish/maintain contact with scientific community
Exceptional technical and problem solving skills, and ability to evaluate computer systems for Data Management
Excellent understanding of clinical trials methodology, GCP and medical terminology
Experience of interaction with major regulatory authorities (not only in India)
Ability to work under pressure, demonstrating a high level of initiative and flexibility

Job Responsibility

Within CDS, lead a regional team comprised of multiple specialized functions and the local resources supporting and/or leading global trials across multiple TAs
Lead and influence across R&D on behalf of their TA Group or Function as a key component of cross-functional R&D planning
Build a brand-new and/or foster CDS departmental presence that has a strong local culture while being a fully integrated member of the worldwide CDS organization
Develop a departmental roadmap starting with the departmental vision, defined through targeted outcomes, strategic initiatives, and tactical deliverables
Ensure strong partnerships within global CDS, across R&D through collaborations with senior leaders (SVP, VP, ED and SD), senior level stakeholders and with external vendors
Act as a thought leader with the network to drive innovation within the organization and across the industry. Lead the conversation in key industry forums through presentations and publications
Lead clinical and non-clinical cross-functional special projects aimed to evolve CDS and partner functions in line with the Pfizer organization and the changing industry landscape
Set current and future strategy as a core member of the CDS Leadership Team
Span of control of 50 or more people or equivalent in terms of functional areas of accountability
As requested, deputize for the responsibilities of the Global Head of CDS

Fulltime

Vice president global head of statistics vcrd

Pfizer is seeking a Vice President, Global Head of Statistics to join our thrivi...

Location

United States , Pearl River; Collegeville

Salary:

274000.00 - 426800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Advanced degree in statistics, biostatistics, or related field required. PhD preferred.
15+ years of experience in drug development
5-10 years of experience in vaccine development
At least 5 years of managerial experience in drug development
Capability to provide statistical leadership to cross-functional teams and the ability to both communicate and influence the biostatical perspective to diverse audiences
Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization
A compelling and inspiring leadership style with a sharp scientific mind, who combines broad knowledge and understanding of biological systems and statistics. A world-class leader in his/her field.
Ability to perform sophisticated mathematical and statistical calculations, and to perform complex data analysis
Disaggregates complex problems to facilitate problem solving
Adept at distinguishing the relevance of information inputs to the decision-making process

Job Responsibility

Sets the vision and leadership for providing the highest level of data management, modeling, and statistical advice across the function to senior Vaccines Research and Development (VRD) leadership
Is accountable to lead the necessary stakeholders to plan, direct and coordinate a large and expanding portfolio of specialized and complex Vaccine Research and Development (VRD) projects spanning phase 1 through phase 4 clinical development
Must have the broadest knowledge of clinical data management and statistical analysis tools and interpret results from clinical, non-clinical, modelling and simulation, and epidemiologic studies
Is accountable to develop and roll out new initiatives and lead the VCRD Statistics group in strategic planning
Leads the activities of Senior Directors directing the statisticians and modelers in VCRD and at Functional Service Providers
Provides senior management review of protocols and CSRs, and is the senior representative to internal review committees, DMC-related company steering committees, etc.
Influences cross functional (TA) activities, in a consultative role, and provides the SVP of Clinical Research with more strategic advice as to the present and future direction for the VCRD Statistics group
Provides the highest level of strategic and statistic leadership to VRD leadership and the full vaccine portfolio
Lead and inspire the VRD statistics organization to provide the highest level of statistical and modeling support. Evaluates the material generated by supervised staff including senior director reports for validity, quality, and effectiveness of presentation and coaches them in preparation for regulatory and Key Opinion Leader interactions.
Provide senior management statistical review of key documents (protocols, CSRs, regulatory briefings)

What we offer

eligibility for 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 support available

Fulltime

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Associate Director, Global Medical Publications

Job Description

Job Responsibility

Requirements

What we offer

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