Senior Director jobs at Daiichi Sankyo - 2518 jobs
Senior Director, Cardio & Renal Statistics Lead
CSL Behring 4.6
King of Prussia, PA jobs
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems.
Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
The SeniorDirector, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development.
This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders.
The SeniorDirector manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional collaboration.
Key Responsibilities
Lead the Biostatistics function for the assigned Cardio and Renal Therapeutic Area (TA), with accountability for statistical deliverables across all stages of clinical development.
Provide statistical thought leadership to Clinical Development teams in the design of clinical development plans, and clinical trials, ensuring robust methodology and alignment with program objectives.
Partner with Therapeutic Area (TA) leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans (CDPs), target product profiles (TPPs), and regulatory submissions.
Ensure high-quality statistical input into study protocols, analysis plans, clinical study reports, and regulatory documentation.
Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA) and contribute to preparation of statistical content in submission dossiers.
Champions the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks (e.g., Go/No-Go criteria, assurance).
Collaborate with other functions (e.g., Epidemiology, Safety) on initiatives such as real-world evidence and patient safety analysis.
Manage, develop, and mentor statisticians within the therapeutic area to build technical capabilities and ensure delivery excellence.
Build relationships and oversee external vendors and CROs to ensure quality and compliance with timelines and standards.
Contribute to departmental strategy, process improvement, and the advancement of statistical methodology and operations.
Qualifications and Experience
PhD in statistics or related field
10+ years of experience in clinical development within the pharmaceutical or biotechnology industry
Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions
Experience partnering with cross-functional teams and interacting with health authorities
People management experience required; mentorship and team-building strongly preferred
Experience managing external partners (CROs, consultants)
Exposure to or leadership of statistical innovation initiatives preferred
Competencies
Strong statistical methodology knowledge and clinical trial design expertise
Ability to collaborate and influence across functions and levels
Excellent communication and interpersonal skills
Experience with CDISC standards, programming oversight, and statistical operations
Strategic and analytical mindset with a focus on execution
Ability to work in a matrixed environment and lead through influence
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$122k-180k yearly est. Auto-Apply 2d ago
Looking for a job?
Let Zippia find it for you.
Senior Manager US Advertising & Promotion Lead
CSL Behring 4.6
King of Prussia, PA jobs
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next Senior Manager US Advertising and Promotion Lead? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional
Position Purpose
Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties.
Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products.
Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance.
Adhere to related SOPs and work instructions for established MCC/PRC processes.
Main Responsibilities and Accountabilities
Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations.
Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL's commercial success.
Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes.
Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas.
Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45.
Maintain technical biologics/medical knowledge for assigned therapeutic areas.
Actively contribute to the global CSL regulatory community through designated projects and assignments.
Review and advise product development teams on communication strategies or tactics regarding investigational products.
Experience
Bachelor's Degree Life Science
Minimum 3 years in Regulatory, Medical, or Legal Affairs or other relevant experience.
Skilled in implementing regulatory science and monitoring enforcement trends.
Ability to read and comprehend product-related technical and medical information.
#LI-HYBRID
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$91k-138k yearly est. Auto-Apply 2d ago
Sr. Director, Omnichannel Engagement US
CSL Behring 4.6
King of Prussia, PA jobs
The Sr. Director, Omnichannel Engagement Leads and develops a high-performing team to drive digital and omnichannel transformation across IBTs/Affiliates/Functions.
Acting as a senior thought partner to Marketing, Medical and Commercial Leaders on a regional level (US/INT) to align strategy and orchestrate adoption of Omnichannel Customer Engagement.
Advocate on behalf of regions/affiliates with
Platform Management
,
Digital & Web Enablement
, and
Content & Omnichannel Excellence
teams to ensure appropriate prioritization, unmet needs communication, and digital capability support
Main Responsibilities and Accountabilities:
Leadership & Vision
Co-create a cohesive omnichannel engagement strategy together with the Omnichannel & Digital Strategy LT as well as with regions across the full product-portfolio
Set long-term roadmap for adoption of tools/systems/frameworks around omnichannel and commercial excellence
Translate senior leadership priorities (Marketing, Medical, Commercial) into actionable omnichannel plans
Stakeholder Partnership
Act as a senior thought partner to Marketing, Medical and Commercial Leaders on a regional level (US/INT) to align on strategy and orchestrate adoption of Omnichannel Customer Engagement.
Partner with and advocate for local and regional needs with global enablement functions (e.g. I&A, I&T, etc.) to ensure the right technological, analytical or other strategically relevant capabilities and projects are successfully executed
Team Leadership & Development
Build, lead, mentor and grow cross-functional team of senior specialists that can deliver across the omnichannel spectrum
Foster learning and professional development and promote a culture of continuous improvement, innovation and responsiveness
Implementation & Operational Execution
Oversee successful rollout/adoption of new systems, tools and processes/frameworks relevant to omnichannel engagement
Ensure integration of right content, right channel, right timing thinking
Design, map, optimize customer journey for different segments in alignment with Marketing, Medical, etc. ensuring that touchpoints across channels are coherent and act with KPIs focusing on ROIs
Use state of the art transformation & change management
Budget & Resource Management
Manage budget within responsibility and ensure to allocate resources (people, partners, tech, etc.) optimally and manage vendor relationships
Position Qualifications and Experience Requirements:
Education
Bachelor's or master's degree in a scientific or business field
Experience
12 plus years' experience in the pharma/biotech industry, with direct commercial experience or IT experience in support of commercial
Strong interpersonal skills to quickly build rapport and credibility with senior leaders
Local knowledge of relevant business, legal, compliance, privacy, security, and regulatory requirements
Multiple years' experience working in an international environment and with matrixed, cross-functional teams
Excellent project management, stakeholder management, communication, and relationship-building abilities
Familiarity with global regulations and cultural nuances
Strong Change and Leadership skills
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$122k-180k yearly est. Auto-Apply 5d ago
Associate Director Clinical Assay Strategy Transplant & Immunology and Immunoglobulins
CSL Behring 4.6
Waltham, MA jobs
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay.
You will be part of a specialized non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a broad and deep knowledge base in relation to development and validation of PK, ADA and biomarker assays. This role requires high excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross functional teams and execute externalization of compliant bioanalytical and biomarker assays . The candidate will need to have a deep understanding the regulatory requirements across bioanalytical and biomarker assay as it relates to different platforms, assay types and context of use.
Main Responsibilities:
Leadership and Strategy
Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company's overall goals and objectives, supporting clinical programs with moderate complexity.
Within a matrix environment provide leadership and mentor scientists within and across functional groups, fostering innovation and excellence.
Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality, regulatory expectations, clinic/submission readiness and associated risks.
Research and Development
Ensure the timely support for progression of projects from nonclinical development through all phases of clinical development, including submissions and post marketing requirements.
Direct the strategy and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance. Identify and proactively manage risk with externalization of critical bioassays.
Establish operational plans to ensure the success technical transfer of assays to external vendors with required compliance, concordance, quality and within timelines to meet project requirements.
Project and Resource Management
Work with Clinical Bioanalytics and Biomarker leadership team to execute robust insourcing outsourcing strategy, ensuring strategic decisions and effective utilization of available resources.
Support the selection of vendors through in depth technical, strategic and scientific review. Contribute to governance meetings, escalation of issues and tracking of KPIs.
Optimize workflows to ensure optimal turn around times, assay transfers, budgets, and resource allocation.
Scientific Oversight
Interpretation of moderate complexity data, ability to troubleshoot and define next steps across areas of expertise for often complex issues.
Recognized subject matter expert in job area typically obtained through advanced education and work experience.
Provide scientific guidance and expertise across the Clinical Bioanalytics and Biomarkers function.
Ensure best practices in experimental design, data analysis, and compliance with regulatory requirements to support project needs.
Contribute to the preparation and review of regulatory submissions, providing expert input on bioanalytical and biomarker data responding to regulatory queries
Communicate scientific results clearly and concisely to appropriate audiences.
Collaboration and Networking
Initiate and foster partnerships with cross-functional CSL R&D teams, external vendors, industry experts, and collaborators to ensure timely project progression and risk management.
Represent the organization at scientific conferences and industry meetings.
Innovation and Technology
Drive innovation by using up-to-date latest advances in platforms, bioanalytical/biomarker formats, assay design and data analysis, automated workflows and use of AI in regulated environments.
Stay updated on advancements throughout the field to support current and emerging modalities.
Qualifications and Experience Requirements:
Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field, Hematology/CVR/Transplant/Immunology.
8+ years' relevant industry experience and / or equivalent experience in a relevant academic environment.
Strong and proven scientific background in relevant Life Sciences discipline.
Demonstrated ability in managing highly effective teams that are cross-functional, multicultural and international.
Deep understanding of relevant regulatory guidance's and industry best practices.
Excellent analytical skills, ability to address complex problems through investigation and analysis.
#LI-HYBRID
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$112k-169k yearly est. Auto-Apply 3d ago
Senior Manager, Targeting
CSL Behring 4.6
King of Prussia, PA jobs
The Senior Manager, Targeting will be responsible for leading the design, implementation, and ongoing management of sales force targeting and alignment processes for US sales forces. This role will ensure that customer segmentation, call planning, and territory alignments are executed with precision to optimize field effectiveness and support brand and corporate strategies.
The position requires strong analytical, operational, and cross-functional collaboration skills to ensure that targeting strategies are aligned with business objectives and are executed in a compliant and efficient manner. The Senior Manager will partner closely with Sales, Marketing, and other I&A teams to provide actionable insights and operational excellence in targeting and alignment.
Responsibilities:
Lead the targeting and alignment strategy for three US sales forces, ensuring optimal customer coverage and resource deployment.
Manage the execution of territory alignment processes, including design, updates, and communication to field leadership.
Partner with brand and field leadership to translate strategy into actionable customer segmentation and call planning.
Conduct geographic and customer-level analyses to identify market opportunities and optimize field force allocation.
Collaborate with cross-functional partners to develop, test, and enhance targeting methodologies, tools, and business rules.
Support periodic alignment refreshes and special projects (e.g., new product launches, resourcing shifts, field force expansion).
Build and maintain processes to ensure accurate, timely, and transparent communication of targeting changes to the field.
Develop reporting and dashboards to monitor territory performance and targeting effectiveness.
Ensure compliance with corporate, legal, and regulatory requirements in all targeting and alignment processes.
Qualifications:
7+ years of experience in pharmaceutical or biotech commercial operations, analytics, or sales force operations.
Hands-on expertise in sales force targeting, segmentation, and territory alignment.
Strong analytical and problem-solving skills with ability to manage large, complex data sets.
Experience with targeting/alignment software platforms and field deployment tools preferred.
Excellent communication and collaboration skills with ability to interact effectively with senior stakeholders and field leadership.
Demonstrated ability to manage multiple projects and deliver results under tight timelines.
Knowledge of US pharmaceutical commercial, legal, and compliance environment.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$91k-138k yearly est. Auto-Apply 2d ago
Associate Director, Data Science & AI
CSL Behring 4.6
King of Prussia, PA jobs
The Associate Director, Commercial Data Science & AI is crucial in driving the overall strategy for (Gen) AI tools and technologies within CSL. This individual will spearhead the application of advanced analytics, machine learning, and AI solutions to unlock new insights, accelerate decision-making, and enhance commercial outcomes across CSL Behring's portfolio. The role will focus on embedding AI and predictive modeling into core commercial processes, including patient identification, Medical and Tender Analytics, forecasting, and customer insights. The AD will serve as a bridge between CSL's commercial business needs and technical innovation, ensuring scalable and responsible use of AI to create measurable business impact. The ideal incumbent brings deep domain expertise, a strong innovation mindset, and a proven track record of translating AI capabilities into impactful business solutions.
In this role you will be reporting in to the SeniorDirector of Commercial Business Analytics Reporting & Data Science.
Lead development and deployment of advanced analytics and AI models to address critical commercial challenges (patient identification in rare disease, HCP segmentation, Medical and Tender use cases)
In close partnership with ABCIA Commercial, Medical Affairs, and Market Access teams to ensure solutions are aligned with strategic business needs.
Translate business problems into well-defined data science use cases and develop proof-of-concept pilots through to production.
Drive adoption of AI-enabled tools across the commercial organization, ensuring business users understand and trust the outputs.
Partner with I&T and Data Governance to ensure responsible AI practices, data quality, and scalable infrastructure.
Drive CSL innovation in the field, leading to high visibility publications in top AI conferences and patents around Generative AI, reasoning, multi-agent systems, etc.
Establish KPIs and frameworks to measure ROI and business impact of data science projects.
Qualifications:
Bachelor's degree required. In Data Science, AI, Computer Science, Statistics, Applied Mathematics, or related quantitative discipline preferred.
10+ years of experience in advanced analytics, data science, or (Gen) AI within pharma/biotech or healthcare; commercial analytics experience strongly preferred.
Strong track record of developing and deploying machine learning models in commercial or clinical contexts. Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions
A deep understanding of the pharmaceutical industry, including regulatory requirements, market dynamics, and emerging AI technologies, with the foresight to identify and map both current and future AI opportunities, is preferred.
Experience leading cross-functional AI/ML initiatives from concept through deployment.
Familiarity with cloud environments (AWS and Snowflake), data engineering workflows, and modern ML frameworks (TensorFlow, PyTorch, scikit-learn) and familiarity with no-code data science SaaS tools.
Demonstrated ability to translate business problems into analytical solutions and communicate results to senior leadership.
Ability to adapt strategies and approaches in a rapidly evolving technological landscape. Additional Qualifications - Preferred
Experience in rare disease patient-finding models a plus.
Experience building evaluation frameworks for LLMs (factuality, faithfulness, bias, toxicity) and human-in-the-loop review
Knowledge of responsible AI frameworks, data governance, and compliance in pharma settings. Experience Leading design, training/fine-tuning, and evaluation of ML/LLM/Agentic systems (retrieval-augmented generation, tool-use, routing, multi-agent workflows).
Ability to thrive in a matrix environment and influence without direct authority.
This is a hybrid role. You are required to be in the office three days a week and one of those days must include a Monday or Friday.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$99k-149k yearly est. Auto-Apply 1d ago
Associate Director, US Field and Channel Insights
CSL Behring 4.6
King of Prussia, PA jobs
Main Responsibilities and Accountabilities:
Accountable for the analysis and the generation of subnational and channel performance insights
Execute analytics projects related to key customer or subnational views
Implement a framework for integrating primary and secondary data sources to monitor performance and identify geographic trends across key customer channels (e.g., HCPs, HCOs, patients, SPs, payers)
Partner with cross-functional leads to enhance business tools/processes, identify areas of improvement, and share best practices related to data and reporting
Collaborate with field and account managers to support review performance and gather field intelligence
Support strategic pull-through of brand initiatives related to accounts and channels
Operationalize collaborative forums with field and corporate accounts leads to support strategic priorities, share intelligence, and generate actionable insights
Manage and deliver communication of account and channel performance narratives to commercial stakeholders
Education
Bachelor of Arts or Science in business, life sciences, or related field.
Experience
10+ years of experience in the commercial pharmaceutical or biotech industry
Strong interpersonal skills to quickly build rapport and credibility with CSL leaders and key external stakeholders.
Demonstrates competencies in problem solving, operations, execution and project management.
Ability to manage multiple projects and stakeholders
Excellent negotiation, communication, and relationship-building abilities
Knowledge of relevant business, legal, and compliance requirements
.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$99k-149k yearly est. Auto-Apply 1d ago
Associate Director, Government Pricing
CSL Behring 4.6
King of Prussia, PA jobs
Main Responsibilities and Accountabilities:
1. Lead and coordinate activities to increase scalability and effectiveness of pricing & government reporting activities through developing integrated processes to leverage organization resources including building efficiencies in processes, systems and harmonization of policies & procedures; continuous process improvement mindset and ability to drive positive change within the organization.
2. Support evaluation, modeling, and provision of strategic insights into the financial and market impact of pricing decisions on government programs and related commercial considerations. Support forecasting efforts including coordination with Finance for updates to GTN & accruals for Government related liabilities
3. Oversee and fulfill all Federal and state specific pricing transparency requirements. Coordinate the activities of both internal and external resources to manage the required data collection and submit all reports needed for compliance.
4. Work with SeniorDirector, Policy Advocacy & Government Affairs, & Legal to interpret and implement updates to CMS guidance, federal regulations, and industry standards. Assist with review and understanding the financial impacts of new/proposed government programs and operational considerations
5. Develop and manage internal reports/dashboards to monitor government exposure and comparison to operations and forecast and update assumptions as applicable
6. Collaborate cross-functionally on design and implementation of pricing strategy, tactics, policies and procedures as they relate to government programs as well as working with internal departments and external stakeholders to resolve data issues and ensure smooth operations.
7. Assist with maintaining and updating all government pricing related internal control procedures, Policies, SOPs and Job Aids on a regular basis to ensure compliance and audit readiness.
8. Support governance and compliance support for Audit, Legal or Finance as requested
9. Provide management oversight on the records supporting the disclosure of data to federal and state agencies. Ensures compliance to federal record retention requirements.
Position Qualifications and Experience Requirements:
Education
Requires a Bachelor's degree, preferably in Business, Life Sciences, or Healthcare Policy and 10+ years of biotech/pharmaceutical experience.
Experience
Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other Federal regulations mandating price and/or transparency disclosures.
Experience with implementation and utilization of financial & pricing systems. Model N preferred.
Strong Excel skills as well as MS Office proficiency
Demonstrated ability to function independently, critical thinking, prioritization and coordination of job responsibilities
Competencies
Simplify complex subjects for broader comprehension.Business Acumen/Strategic Thinking
Collaboration across multiple functions Change Management & Process Improvement
Integrity and Trust
Ability to Influence without authority
Executive Presence
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
Job Title: Associate Director, Strategic Forecasting and Portfolio Analytics
Reporting to: Director, Strategic Forecasting & Portfolio Analytics
· Reporting to the Director of Strategic Forecasting & Portfolio Analytics, you will lead forecasting programs centered around decision analytics for the CSL portfolio.
· You will lead forecasting projects across Hematology CSL therapy area. This role will be the direct point of contact for all forecasting needs for the commercial development of in-line and pipeline assets
· This position is critical for investigating and answering key business questions globally, influencing R&D and clinical programs, guiding asset strategy, and contributing to go-no-go decisions of various development programs across CSL
· You will be a trusted partner, both within the Global Forecasting & Portfolio Analytics team and across the organization
· You will lead the Long-Range Plan for Hematology and its end-to-end execution.
Main Responsibilities & Accountabilities:
• Lead the development and management of comprehensive long-term forecasting models for global therapeutic areas, ensuring accuracy and alignment with business objectives.
• Collaborate closely with therapeutic area leaders within commercial development organization as well as PST/GPLs within R&D, and commercial & corporate finance teams to integrate forecasting insights into the annual long-range planning workstream and other strategic initiatives
• Provide strategic guidance on market trends, competitive landscapes, and emerging therapeutic opportunities to inform global forecasting and business strategies
• Manage and work with a team of contractors and offshore resources to deliver long-term strategic volume and revenue forecasting projects covering multiple CSL therapeutic areas
• Oversee sales data analysis, market research, and external benchmarks to develop robust and reliable forecasts
• Present forecast scenarios and recommendations to senior leadership and key stakeholders, ensuring alignment with organizational goals and market expectations
• Collaborate and support other functions within the Forecasting COE - particularly BD&L, three-year forecasting, and Portfolio/Decision Analytics
• Lead the execution of long range-plan which entails coordinating with the short-term forecast team/regions to along on the 3-year forecast; Developing 4-to-10-year volume forecast (baseline & events); Alignment with Global & Regional and pricing teams through review meetings/workshops; Overseeing scenario modeling; forecast submission
• Stay updated on industry trends, regulatory changes, and advancements in forecasting methodologies within the biotech and pharmaceutical sectors
Qualifications & Experience Requirements:
· Minimum of a Bachelor's Degree with preferred focus in a scientific or business field (decision sciences, finance, analytics, economics, analytics/statistics or related). Post-graduate qualifications preferred.
· 10+ years experience in the pharmaceutical/biotechnology industry working across multiple therapeutic areas; plus at least 5+ years or experience running/leading forecasting/analytics teams in biotech/pharma industry
· Strong analytical and problem-solving skills, with the ability to translate complex data into actionable insights.
· Excellent communication and stakeholder management skills, with the ability to influence and collaborate effectively across functions and levels of the organization.
· Strength in storytelling, data visualization, and developing effective presentations
· Ability to prioritize and manage multiple priorities in a lean organization; Experience working in multi-site/global environment
· Experienced with multiple forecasting & BI tools including Flexicast, Forecast Pro, Decision Suite/@Risk or any monte carlo simulation tools, Tableau, QlikSense etc.
· Experience with multiple epi, sales, and syndicated datasets such as Oracle EpiDB, Datamonitor, Clarivate, Evaluate Pharma, Globaldata, IQVIA, Symphony, ADIVO, GERS, UNOS etc.
· Experience working with Rx, patient claims, pricing (WAC) and managed markets data sources (e.g. IQVIA, SHS, MMIT, Komodo, Clarivate, IPD Analytics)
· Entrepreneurial attitude and approach; Positive attitude and strong collaboration skills
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$99k-149k yearly est. Auto-Apply 1d ago
Associate Director, Business Analytics
CSL Behring 4.6
King of Prussia, PA jobs
The Associate Director of Business Analytics US I&A is data and analytics leader in support CSL‘s brand teams with strategic insight through quantitative analytics and reporting. The role is to guide the Business Team to proactively plan, design and lead initiatives for in-line and launch products. Contribute to the development of portfolio and brand strategy development through understanding the quantitative and qualitative market context and CSL Behring's strategic opportunities. Develop metrics, KPI Dashboards, and other tools to quantify key performance indicators that connect strategic intent with tactical execution.
The role will serve as the subject matter expert on healthcare data and will coach & mentor other analysts/Managers on use/best practices.
The incumbant will take a leadership role in making CSL Behring more responsive to market changes driven by consumer needs and competitive dynamics. With strong business acumen, this role must be able to integrate and cross analyze both quantitative and qualitative information from multiple sources into a comprehensive evaluation with well supported recommendations that are relevant, timely and actionable. An entrepreneurial mindset and a drive to grow with the position are most important success factors.
Responsibilities
As a leader in business analytics team proactively plan, manage and execute commercial data modeling and scenario analysis using a mix of competitive intelligence, secondary and primary research techniques as needed.
Deliver high quality, timely and actionable insights that characterize opportunities and risks and translate into clear management recommendations with associated implications for the business.
As a technology leader in manage & support enterprise analytical projects, platform development, data acquisitions, analytical vendor relationships, Omnichannel etc..
Decision support using a broad range of quantitative techniques to analyze, interpret and understand main business and market dynamics. Present detailed quantitative analysis and qualitative insights to senior leadership in a manner that is easily interpreted and aids strategic decision-making.
Operate as a business partner to CSL Behring brand teams through provision of research and analysis to provide quantitative market, competitor and brand insights.Build a working relationship with US Market Research & CI leads to develop a deeper understanding of patient dynamics, competitive landscape to proactively identify growth opportunities for CSL US portfolio.
Partner with external vendors to initiate secondary data research to identify the barriers and opportunities for demand generation in CSL brands.
For assigned projects, monitor, control, and negotiate all research & analytics related expenses to ensure the cost-effective use of resources.
Strong business acumen & presentation skills to senior leadership to aid & influence the data driven decision making.
Qualifications
Bachelors degree with quantitative focus required (engineering, statistics, mathematical sciences, economics). Master's Degree preferred
8 to 10 years' professional experience with a focus on quantitative analysis and decision support.
Advanced Knowledge of Pharmaceutical data including but not limited to IQVIA Claims, DDD, Symphony Non Retail, SP Claims
Prior commercial analytics experience in Rare diseases, oncology , novel therapies or Biotech is a huge plus.
Prior experience in management consulting, Brand analytics, patient analytics or Market Access analytics or equity research analysis.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$99k-149k yearly est. Auto-Apply 1d ago
Associate Director, Field Reimbursement Manager Resourcing
CSL Behring 4.6
King of Prussia, PA jobs
The Associate Director, Field Reimbursement Manager Resourcing (FRM), US Portfolio, is responsible for developing and implementing in office resources and solutions across the portfolio to support HCP and patient access to CSL products. The individual will collaborate across functions in the development of customer specific needs delivered by a field-based reimbursement manager team. In addition, the incumbent will lead key go-to-market activities in preparation for launch and support the team in the development of customer needs by connecting larger market access requirements to local healthcare professionals.
The role will be responsible for FRM resourcing across the portfolio, as aligned with brand needs.
Main Responsibilities and Accountabilities:
Lead market and customer insights to support access to US CSL Portfolio
Develop resources in collaboration with FRM leadership to help advance access to CSL products
Work closely US brand leaders, Patient Experience Leadership, Strategic Pricing and Contracting and Policy Advocacy and Government Affairs to provide a point of view and resourcing to advance customer engagement
Develop brand specific customer segment strategies to inform FRM resourcing needs
Active participation in the development of value-based care delivery and while advancing capabilities in field reimbursement
Advances process, standards and operational plans to advance CSLs capabilities of field reimbursement and resourcing.
Provides frequent updates to executive leadership while managing large complex initiatives that are aligned to the US Commercial vision of field reimbursement
Lead large cross functional teams with an orientation to the external market to identify thought partnership, trends and future standards that enable greater patient access to CSLs portfolio
Utilizes systems, measurement and analytics to advance platforms of field reimbursement teams while acting on trends and insights to build continued capabilities
Position Qualifications and Experience Requirements:
Education
Required: BA/BS Degree
Experience
Minimum of 10 years combined healthcare industry experience, including at least 3 years in marketing or market access
Demonstrated understanding of the in-office reimbursement
Demonstrated understanding of US healthcare trends and policy issues and their potential impact upon our company's business opportunities
Strong knowledge of marketing principles, with ability to leverage data analytics and activate market research for insights
Ability to translate market trends and customer needs into customer resources or tactics.
Ability to learn quickly and to assess a variety of scenarios, strategically and operationally
Demonstrated strategic thinking, complex problem solving, analytical critical thinking
Excellent leadership and communication skills
Demonstrated success in establishing, developing and maintaining business relationships
Strong collaboration, with “Win as one team” mindset
Preferred Experience and Skills:
Experience in healthcare related commercial and / or reimbursement of biologics or medical device
Experience developing field-based resourcing / reimbursement support materials
Previous experience in Rare Disease
Product launch or launch planning
Consulting/Stakeholder Management experience in cross-functional capacity
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$99k-149k yearly est. Auto-Apply 1d ago
Associate Director, Corporate Accounts
CSL Behring 4.6
Hartford, CT jobs
The Associate Director, Corporate Accounts is responsible for managing all aspects of CSL's business within a defined group of Specialty Pharmacies, Specialty Distributors, Group Purchasing Organizations, IDN's, ACO's and Hospital accounts. This includes acting as the primary point of contact for CSL with the accounts, analyzing and understanding sales trends for each product sold to each account, achieving defined goals and objectives, and promoting a mutually beneficial business relationship while adhering to CSL Behring Core Values. Works closely with the SeniorDirector, Corporate Accounts to establish strategic and tactical initiatives that align closely with those of key CSL brands. Also responsible for cultivating a close relationship with cross functional Team colleagues in Sales, Medical Affairs, Marketing and Market Access to implement corporate, market access and brand specific strategies and tactics.
Acts as the primary point of contact for CSL with assigned accounts. Fosters and develops multi-level and senior relationships within assigned accounts and affiliated organizations to create a foundation for developing new business opportunities. Develops internal champions within each account.
Analyzes accounts' near-term and longer-term objectives and promotes consideration of company products and services to meet and align with identified objectives. Develops strategic account and sales plans to increase penetration of CSL Behring products. Provides timely feedback to CSL regarding accounts and resulting effect on CSL sales. Provides timely and accurate forecast for each assigned account.
Maintains thorough depth and breadth of customer interaction at various (senior management and operational) levels of the customer's organization, builds and maintains relationships with key individuals to enable market access of CSL's products and a favorable environment for pull-through at the national, regional and local provider levels.
Secures meetings with appropriate customer personnel to review the clinical and reimbursement information and adopt appropriate treatment protocols and policies that are supportive of CSL therapies.
Represents CSL Behring at key Institutional, trade and Specialty Pharmacy Association meetings. Contributes to training on appropriate topics for CSL sales representatives, MSL and others, as needed.
Integrate with Regional Business Managers (RBM) to drive penetration and initiative implementation in each region. Integrate with other Account Managers to coordinate and leverage relationships to ensure CSL Behring therapies are properly integrated with end-user customers.
Troubleshoots accounts to overcome clinical issues and barriers involving the company's product portfolio. Key tasks will be to educate selective customers on the company, and the unique benefits involving CSL products and programs available to support their appropriate use.
Collaborate with business teams, marketing and medical affairs to ensure alignment and full utilization of resources at account level. This includes utilization of marketing material, execution of in-services, development and execution of marketing or other service agreements.
Manages Corporate Account Management process to ensure account objectives are met. Organizes structured quarterly business reviews, ensuring appropriate CSL and customer participation.
Qualifications:
Bachelor or Master degree in a scientific or business field preferably in in Business, Pharmacy, Health Policy or Life Sciences, or equivalent experience.
8-10 years' experience in sales management and/or large account management
Experience in product marketing and/or sales of pharmaceutical/biotech products
A proven track record of successful large account management, market share growth and product profitability, with:
extensive knowledge of the US health care market
broad knowledge of US healthcare delivery, financial and reimbursement mechanisms.
experience in executing strategies through cross-functional teams.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$102k-154k yearly est. Auto-Apply 1d ago
Director, Epidemiology
CSL Behring 4.6
King of Prussia, PA jobs
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three days onsite.
Responsibilities:
• As the epidemiology lead for designated products proactively define epidemiology research strategies to contribute to R&D and Commercial objectives.
• Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports.
• Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests).
• Lead structured benefit-risk assessments, using qualitative and quantitative methods.
• Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company.
• Assist the head of department to facilitate ongoing development and growth of the department.
• Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc.
Qualifications:
• Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master's degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry.
• Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products. Ability to proactively advise and lead product teams in this regard.
• Sustained autonomous performance as epidemiology lead to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity.
• Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting.
• Demonstrated experience leading organizational process improvement or change management initiatives.
• Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities.
#LI-HYBRID
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ***************************
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$56k-110k yearly est. Auto-Apply 2d ago
Director, BD&L Forecasting
CSL Behring 4.6
King of Prussia, PA jobs
The Opportunity:
Reporting to the SeniorDirector of Global Forecasting & Portfolio Analytics, you will lead the BD&L forecasting and Analytics for Cardiovascular and Renal (CVR) and Transplant and Immunology (T&I) therapy areas
In this role, you will drive decision-making across all BD&L due diligence efforts via commercial revenue forecasting for both pre- and full-fledged due diligence workstreams and represent Insights & Analytics (I&A) forecasting within the commercial due diligence team
You will be expected to follow all CSL I&A forecasting standards, ensuring accuracy and alignment with business stakeholders
You will be the primary point of contact representing I&A forecasting for maximization and special projects across the CSL portfolio
This role would require strong consultancy orientation and the ability to communicate effectively and efficiently with all organizational stakeholders.
As a part of the Global I&A team, you will play a pivotal role in shaping our strategic direction and optimizing our pharmaceutical portfolio.
The Role:
Lead end to end forecasting & analytics efforts for all business development workstreams at CSL for CVR and T&I
Would include conducting high level assessments for early research stage assets as well as deep dive commercial assessments and valuations for late-stage opportunities or a mix of both
Would need prior experience with conducting and validating market research and competitive landscape analysis along with thoughtful incorporation into BD&L forecasts
Would need the ability to plan, execute and deliver multiple time sensitive projects with both accuracy and speed under tight timelines
Leverage internal forecasting standards and triangulate inputs from R&D, Commercial Development, Market Research, Competitive Intelligence, Pricing & Access, Legal/IP to create robust and defendable forecasts/scenarios
Represent Forecasting and Portfolio Analytics function within commercial due diligence team, providing critical insights and analysis to support strategic decisions.
Collaborate with cross-functional teams to integrate data-driven insights into strategic planning, commercial strategies, and decision-making processes.
Oversee the analysis of market trends, competitor landscapes, and emerging technologies to identify opportunities and risks for business growth.
Provide leadership in the evaluation of potential partnerships, licensing agreements, and M&A opportunities by delivering data-driven insights.
Stay updated on industry trends, regulatory changes, and advancements in forecasting and analytics methodologies within the biotech and pharmaceutical sectors.
Support to ensure strategic fit of opportunities coherent with CSL TA strategy
Drive continuous improvement in BD&L forecasting capabilities within the Forecasting COE, including identification of talent gaps and develop training programs to enhance team capabilities
Qualifications:
Minimum of a bachelor's degree with preferred focus in a scientific or business field (finance, analytics, economics, analytics/statistics or related). Post-graduate qualifications preferred
10+ years' experience in the pharmaceutical/biotechnology industry working across multiple therapeutic areas
6+ years of experience running/leading forecasting teams in biotech/pharma industry
Hands on expertise with all forecasting techniques including time series modeling and statistical trending algorithms, patient-based/TRx modeling
Experienced in multiple forecasting & BI tools including but not limited to Forecast Pro, @Risk or other monte-carlo simulation tools, Tableau, QlikSense etc.
Experience with conducting detailed literature reviews for Epidemiology as well as expertise & thoughtful utilization of available datasets such as Oracle DB/Legacy Kantar, Datamonitor, Evaluate, Globaldata, IQVIA, Symphony, ADIVO, GERS, UNOS etc.
Experience working with Rx, patient claims, pricing (WAC) and managed markets data sources (e.g. IQVIA, SHS, MMIT, Komodo, Clarivate, IPD Analytics)
Strong interpersonal skills to quickly build rapport and credibility with organization leaders and key external stakeholders
Extensive experience leading planning cycles in commercial, forecasting, or analytical roles
This is a hybrid position out of our King of Prussia offices. You must be in the office 3 days a week and one of the days must include a Monday or Friday.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
$56k-110k yearly est. Auto-Apply 1d ago
Director of Marketing & Customer Analytics
Avara 4.1
Dallas, TX jobs
Reports to: Director of Planning & Analysis
Shop Avara is seeking a strategic and hands on-leader as our Director of Marketing and Customer Analytics to lead data-driven insights that fuel growth of our brand. This role will be the go-to partner for the Marketing and E-commerce teams - helping the organization deeply understand customer behavior, campaign performance, attribution, and lifetime value. You will blend analytical rigor with business understanding, turning complex data into actionable findings that can allow the marketing team to optimize acquisition, retention, and engagement. The ideal candidate thrives in a fast paced, entrepreneurial environment and is passionate about using data to unlock profitable customer growth and brand potential.
Key Responsibilities
Customer & Audience Insights
Lead deep understanding of who our current customer is - their motivations, preferences, purchase drivers, and behavioral patterns.
Own customer segmentation and profiling to identify high-value audiences and behavioral patterns.
Analyze customer acquisition, retention, repeat purchase, and churn dynamics across channels.
Build and maintain dashboards tracking customer KPIs (LTV, CAC, retention rate, frequency, AOV).
Partner with the Marketing and E-commerce teams to inform targeting, personalization, and lifecycle strategies.
Marketing Performance Analysis
Lead measurement and reporting of marketing campaign performance across paid, owned, and earned channels.
Build and refine marketing attribution models to assess ROI and inform budget allocation.
Identify drivers of traffic, conversion, and engagement to optimize channel strategy and creative direction.
E-commerce & Digital Analytics
Collaborate with the E-commerce team to monitor site performance, conversion funnel, and customer journey metrics.
Conduct deep-dive analyses on site behavior to identify conversion opportunities and UX improvements.
Partner on A/B testing strategy and post-campaign performance evaluations.
Data Infrastructure & Tooling
Work with Data Engineering partners to ensure data pipelines, tagging, and integrations are optimized for marketing measurement.
Define data requirements and metrics for new marketing channels, campaigns, and customer programs.
Implement and manage analytics tools and visualization platforms (e.g., GA4, Looker, Amplitude, or similar).
Cross-Functional Partnership
Work closely with FP&A to align marketing performance insights with financial outcomes (CAC, payback, contribution margin).
Collaborate cross functionally on insights that inform product development and brand storytelling.
Present findings and strategic recommendations to cross functional partners and leadership in a clear, compelling, and actionable way.
$87k-139k yearly est. 4d ago
DIRECT HIRE - Mitsubishi Tanabe Pharma America - Senior Director, Trade & Distribution
Eversana 4.5
Jersey City, NJ jobs
EVERSANA has partnered with Mitsubishi Tanabe Pharma America, Inc. for this Direct Hire opportunity. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan's most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson's (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.
MTPA is rapidly expanding its operations across all functional areas. MTPA's commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA (edaravone) injectables in 2017 and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.
Job Description
Direct Hire Opportunity!
The SeniorDirector, Trade & Distribution, will build, lead, and manage the team while focusing on developing strategies to support the launch and lifecycle management of our leading Parkinson's and ALS therapies, as well as future products in the United States. The primary responsibility of the SeniorDirector Trade & Distribution is to develop and implement the distribution strategies across the specialty businesses. This includes specialty pharmacies, distributors and all channels that would support any present or future MTPA products. This person will have an intimate knowledge of the distribution systems from all aspects including durable medical equipment. The ideal candidate will possess strong leadership experience in managing teams that work both directly and indirectly with specialty vendors, coupled with exceptional analytical skills to identify operational gaps and implement effective solutions. Cross-functional collaboration with supply chain, marketing, sales, and customer-facing teams will be key to success in this role.
Responsibilities
Provides overall leadership and direction for Trade Market Access strategy for Mitsubishi Tanabe Pharma US' lead Parkinson and ALS products
Evolve and innovate distribution network by aligning it with business needs, identifying growth opportunities, and addressing operational gaps to overcome challenges and drive access. Serves as the Distribution and Trade Strategy Team Leader, representing
trade across all teams and driving key success factors to support long-term distribution strategies. Lead the development and execution in Federal Markets, including VA and Department of Defense to drive product access, distribution, and growth. Act as subject
matter expert from a Market Access perspective for 340B program and other government programs.
Informs senior and corporate executives informed about changes and emerging issues in the broad, trade customer environments and subsequent implications for Mitsubishi Tanabe Pharma US
Develops awareness of market and government policy changes in collaboration with legal and compliance and implications across key stakeholders to help inform/update commercial strategies
Assists market access marketing agency (and other vendor relationships) to develop promotional programs, tactics and materials aligned with our distribution process
Develops/maintains thorough understanding of dynamics driving various market access segments and channels and how distribution impacts each function
Effectively manages budgets and project timelines including contract management
Oversight in the negotiation, execution, and adherence to the Distribution Service Agreements (DSAs), Product Purchase Agreements, and other contract offerings as appropriate
Develop account metrics against strategic, financial, and product access KPI's
Develops and monitors KPIs, continually assessing impact and execution of access services & offerings including feedback from service users and internal stakeholders
Attends professional, provider programs, and patient conferences, and keeps up to date on innovation and recommends ways to improve business.
This is a home office based position. The expectation is to be in the office 3 days a week.
Qualifications
Bachelor's Degree Required, Masters preferred
Must have 15 plus years within the pharmaceutical industry and 10 years' experience in Distribution, Account Management or Aligned Market Access functions.
Experience with distribution for early-stage pipeline programs
Experience in Federal Markets including VA, Department of Defense and 340B Program preferred.
Device/Drug combination strongly preferred
Minimum 5 years of people management experience required
Track record of closing complex negotiations within the specialty pharmacy arena
Preferred experience includes:
All aspects of distribution
Launch and life cycle management for the distribution process
Experience in Market Access marketing
History of successful negotiations
Broad based knowledge of the Pharma/Biotech industry, healthcare finance, and all forms of product distribution: DME, Orals, and Solutions
Firm grasp of legal, regulatory and compliance issues in the healthcare space
Analytical/strategic thinker with proven ability to:
conduct situation analysis of the external distribution environment; synthesize relevant information to develop strategic plans
understand the best pathway for distribution based on the product and its attributes
conduct strategic gap analysis and implement metric-based solutions
Strong interpersonal and internal/external relationship-building skills in order to drive change and innovation and succeed in a highly specialized distribution environment
Excellent oral/written communication skills, coupled with exceptional presentation skills, including ability to present to large audiences
Ability to prioritize and manage complex projects, with multiple stakeholders, and drive high-quality results within allotted budget
Highly proficient in MS Office; advanced Excel skills
Must be able to travel domestically and internationally (approximately 40%)
Additional Information
Mitsubishi Tanabe Pharma America Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.
MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.
$133k-196k yearly est. 3d ago
Director, Market Access and Marketing
EPM Scientific 3.9
Trenton, NJ jobs
Director, Marketing & Access Strategy
Trenton, NJ (4 days on-site)
A fast‑growing, commercial‑stage biopharmaceutical organization with an expanding portfolio across oncology, dermatology, and biosimilars is seeking a hungry access & marketing expert for their specialty product. This highly visible role will lead market access and strategic marketing efforts for a major upcoming launch. If you excel in dynamic, scaling environments and want to make a direct impact on patient access and brand success, this could be your next opportunity!
Key Responsibilities:
Market Access Strategy & Execution: Build and refine strategies to optimize coverage, pricing, reimbursement, and distribution across Commercial, Medicare, VA/DoD, GPOs, and corporate accounts.
Translate clinical and economic data into compelling payer‑focused messaging and materials for key stakeholders across payers, IDNs, and provider systems.
Stay ahead of market access trends, policy changes, and competitive shifts, communicating impact and recommended actions to senior leadership.
Create payer and field‑facing access materials supporting both corporate account teams and sales teams.
Provide strategic insights for pricing and contracting in buy‑and‑bill, Part B, and specialty pharmacy environments.
Manage patient and reimbursement support services and ensure all projects are delivered on time and within budget.
Qualifications:
8-10 years pharmaceutical experience, including 3-5 years in Market Access.
Experience in oncology, rare disease, or biosimilars strongly preferred.
1-2 years of HCP marketing experience is a plus.
Prior launch experience in branded and/or biosimilar markets.
Strong cross‑functional collaboration skills, including agency management.
Comfort working in fast‑paced, evolving, start‑up‑like environments.
Ability to travel up to 30%.
Note: Applicants who do not meet the above qualifications will not be considered
$98k-163k yearly est. 3d ago
Sr Director Engineering
PCI Pharma Services 4.1
Philadelphia, PA jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary Of Objective
The main responsibilities of the Sr. Director - NPI Engineering is focused on the planning and execution of projects from estimating to launch:
Manage and communicate the site portfolio of NPI projects, ensuring projects are managed to intended capital and resource cost and scope
Provide resources and oversight to project estimating activities to develop a trusted project resource plan
Own the resource planning process for the NPI engineering team, coordinated with other functional leaders (quality, validation, facilities, etc.) providing resources to project teams.
Provide support to project teams, taking on risk mitigations, issue resolution, and escalations to ensure on-time launches at target quality and unit cost
Leading change and continuous improvement activities for the NPI process
Primary Key Performance Indicators (KPI) are On Time Equipment Commissioning and Product Launch; Project Cost Performance; Product Launch Quality and Cost Target Achievement
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Oversees NPI engineering project management.
Supervises a staff of engineers and/or engineering technicians and provides guidance, leadership, and mentorship in areas of engineering, project management, and professional development.
Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan.
Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements.
Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive bids and analysis developed by site Project Managers.
Adapts NPI engineering organization to meet changing product portfolio and customer demands through appropriate hiring and organizational structuring.
Communicates significant equipment or process issues to site leadership.
Measure and analyze performance metrics of the NPI project portfolio, and undertake escalations to address time, cost and scope issues.
Ensure effective communication, planning and coordination between other functions
Prepares equipment/engineering estimates for potential projects (to be submitted to sales).
Analyzes sales requests to determine equipment, tooling, or delivery systems needed.
Oversee the Engineering review of all components for new jobs (size, capability of equipment, bar codes).
Conducts and/or participates in customer meetings and attends occasional off-site meetings.
Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
Responsible for the administration, implementation, and project management of assigned projects, including using company-wide standardized methodology.
Coordination of outside design, integration, and equipment manufacturing services.
Manages the site facilities and utilities to accommodate new equipment and meet all regulatory requirements.
This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required
Bachelor's Degree in Engineering or related field
7-10 years experience in a related industry
College Level Mathematical Skills
Program and Project management
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
High standard of report writing.
Preferred
Ability to adapt to changing work environments.
Ability to effectively present information to various people as the job requires.
Ability to work independently and/or as part of a team.
Ability to display excellent time management skills.
Lean/Six Sigma training
GAMP5 experience with drug-device assembly processes
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
$100k-154k yearly est. 1d ago
Director GHEOR
EPM Scientific 3.9
Conshohocken, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
$55k-110k yearly est. 2d ago
Director GHEOR
EPM Scientific 3.9
Philadelphia, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.