The R&D Digital Enablement Lead ensures that the people, processes, and systems across R&D are fully prepared to adopt and benefit from digital transformation. This role drives agile delivery, change management, and process design to accelerate adoption and value realization of digital solutions within the scientific organization.
Main Responsibilities & Accountabilities
•Lead business analysis and discovery to align TES digital projects with R&D priorities.•Drive process design, reengineering, and operating model evolution for digital programs.•Oversee agile delivery frameworks and support scrum teams as needed.•Lead change management and communication strategies for adoption.•Monitor value realization and build metrics frameworks to assess progress.•Collaborate with R&D stakeholders to continuously improve digital workflows.
Qualifications & Experience Requirements
•Bachelor's or Master's in Business, Life Sciences, or Technology-related field.•12+ years of experience in digital transformation, business analysis, or change management.•Proven success delivering agile initiatives in a global scientific or R&D setting.•Experience with tools such as Jira, Smartsheet, Miro, or similar.•Strong understanding of stakeholder engagement and adoption strategies.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 4d ago
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Senior Director, AI/ML/Advanced Analytics, Automation & Digital Agent CoE
CSL Behring 4.6
King of Prussia, PA jobs
The AI/ML Advanced Analytics, Automation & Digital Agent CoE Lead is responsible for shaping and executing the AI and automation strategy across R&D. This role integrates advanced analytics, machine learning, intelligent automation, and digital agents to drive scientific and operational excellence. The leader oversees capability building, governance, technical standards, and external engagement to deliver innovation at scale while ensuring compliance and measurable business value.
Main Responsibilities & Accountabilities
•Define and implement integrated AI/ML and automation strategy across R&D, aligned with business priorities.•Oversee development and deployment of advanced analytics models, automation tools, and digital agents to streamline R&D processes.•Lead governance and establish standards for responsible AI, ML Ops, and automation toolkits.•Collaborate with internal stakeholders (e.g., Digital Business Partners, I&T, lab owners) and external groups (e.g., TransCelerate, Pistoia Alliance) to identify, pilot, and scale impactful use cases.•Develop talent, tools, and platforms through training, hackathons, guilds, and workshops.•Ensure integration of automation and agentic solutions with data platforms and existing workflows.•Track KPIs such as efficiency gains, accuracy improvements, and user adoption.•Support audit readiness and ensure compliance with regulatory expectations for AI and automation
Qualifications & Experience Requirements
•Bachelor's or Master's degree in Data Science, Engineering, Computer Science or related field.•12+ years of leadership in AI/ML, automation, or advanced analytics within life sciences.•Proven success in model development and.or digital agent deployment in R&D environments.•Deep expertise in ML Ops, data science platforms, automation frameworks, and AI governance.•Familiarity with scripting, middleware, and low/no-code tools for automation.•Strong user-centered design approach and experience with change management.•Knowledge of regulatory frameworks and compliance in AI-enabled systems.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 5d ago
Director, Search Platform Lead
CSL Behring 4.6
Waltham, MA jobs
Responsible for the strategy, development, and optimization of digital platforms that support external innovation, business development, market analysis, and competitive intelligence. This role ensures the organization has a strategic edge by enabling timely, accurate, and actionable insights from external data sources, partnerships, and market signals.
Main Responsibilities & Accountabilities
•Lead the design and evolution of search and intelligence platforms that aggregate and analyze data from scientific literature, patents, clinical trials, market databases, and competitor pipelines•Collaborate with business development, R&D, strategy, and digital teams to define platform requirements, use cases, and key performance indicators (KPIs)•Integrate AI/ML, NLP, and semantic search technologies to enhance discovery, relevance, and insight generation•Manage external vendors and data providers, ensuring high-quality service delivery, innovation, and cost-effectiveness•Establish governance for data sourcing, tagging, access, and compliance with licensing and privacy regulations•Drive user adoption through training, support, and continuous improvement based on feedback and analytics•Monitor emerging technologies and trends in competitive intelligence and digital search to maintain a strategic advantage
Qualifications & Experience Requirements
•Bachelor's or Master's degree in Life Sciences, Data Science, Information Systems, or a related field•12+ years of experience in digital platforms, competitive intelligence, or external innovation within a scientific or business development context•Strong understanding of search technologies, data integration, and analytics platforms•Experience managing external vendors, data subscriptions, and technology partnerships
Excellent communication, stakeholder engagement, and strategic thinking skills
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.
$76k-153k yearly est. Auto-Apply 4d ago
Associate Director - Statistics
Takeda 4.7
Cambridge, MA jobs
Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Our Data and Quantitative Sciences(DQS) is committed to harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.
As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence.
Delivery & Business Accountabilities:
Lead delivery for one or more assets at GPT level or specialty area in clinical
Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors
Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission
Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation
Create an internal cross functional and external with vendors sphere of influence in predictable delivery
Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them
Contributions:
Asset-level GPT strategy and delivery
Broadly DQS functions
Parts R&D functions.
Core Elements Related to this Role:
Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
Strong statistical programming skills
Excellent oral and written communications skills.
Specialized statistical expertise in multiple therapeutic areas or development phases.
Strong inter-personal and people management skills.
Strong project management skills.
Strong collaborative skills and ability to work with a cross-functional team.
Technical/Functional (Line) Expertise:
Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics
Scientific understanding of drug R&D to inform methodological input with product team or in a platform
Strong communication skills and ability to translate effectively across functional lines
Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs that he/she is involved in
Leadership:
Lead one or more assets at GPT level or specialty area in preclinical, clinical, translational
Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D
Enable the tactical execution of the SQS and DQS vision and mission
Lead and be accountable for asset level strategies being implemented
Demonstrate mentorship, matrix or direct management of small team of SQS colleagues
Create an internal and external sphere of influence in area of expertise
Education:
PHD with ~ 5 years experience
MS with ~ 8+ years experience
Behavioral Competencies:
Inspire teamwork
Assess benefit risk of options
Develop understanding of business beyond SQS
Focuses on priorities
$128k-194k yearly est. 5d ago
Associate Director Pricing and Contracts
EPM Scientific 3.9
Boston, MA jobs
AssociateDirector, Contracts and Pricing
Department: Market Access
About Our Client Our client is a global leader in healthcare innovation, focused on improving patient access and delivering value through science and technology. They operate across prescription medicine, consumer health, and specialty care, driving growth through strategic partnerships and cutting-edge solutions.
Job Summary
The AssociateDirector, Contracts and Pricing - Prescription Business Unit (U.S.) will lead initiatives to develop, model, execute, and measure access and reimbursement strategies. This role ensures successful product launches, maximizes market adoption, and supports lifecycle management from early development through loss of exclusivity.
Key Responsibilities
Achieve financial targets: manage forecasts, invoices, accruals, and validation through budgeting and financial review processes.
Oversee market access and reimbursement operations, including managed care contracting, payer negotiations, and rebate budgets.
Lead Gross-to-Net modeling for portfolio and new launches; develop robust forecasts using contract data and insights.
Collaborate with leadership and cross-functional teams to align on market access strategies and GTN assumptions.
Serve as SME for payer negotiations; assess risks and opportunities to inform contract terms and conditions.
Manage communication plans, KPI reporting, and compliance with healthcare regulations.
Support business development and new product launches with market access assessments and go-to-market strategies.
Qualifications
Strong experience in market access, pricing, and contracting within the pharmaceutical or healthcare industry.
Expertise in financial modeling, forecasting, and payer negotiations.
Ability to manage complex projects and collaborate across functions.
Excellent analytical, communication, and strategic thinking skills.
$112k-169k yearly est. 5d ago
Associate Director Regulatory Affairs
EPM Scientific 3.9
Boston, MA jobs
Title: AssociateDirector of Regulatory Strategy
A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented AssociateDirector of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development.
Key Responsibilities
Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.
Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters.
Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor.
Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.
Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities.
Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation.
Qualifications
Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development.
Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).
Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
Familiarity with 505(b)(2) development strategies or innovative delivery platforms.
Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas.
Proven track record of successful interactions with the FDA and/or global regulatory agencies.
Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.
$112k-169k yearly est. 2d ago
Director, Clinical Operations
EPM Scientific 3.9
San Francisco, CA jobs
San Francisco, CA - Hybrid
$200,000 - $250,000
Director, Clinical Operations - Emerging Metabolic Biotech
Join an early-stage biotech on a mission to transform metabolic disease treatment. Our client is building a first-in-class metabolic pipeline and seeking a Director of Clinical Operations to lead the execution of thier initial clinical programs.
What You'll Do
Own end-to-end clinical operations strategy and delivery for early-phase trials.
Select and manage CROs, vendors, and sites to ensure quality and timelines.
Drive inspection readiness and compliance across global studies.
Partner cross-functionally with Clinical Development, Regulatory, and CMC teams to shape program strategy.
What We're Looking For
10+ years in clinical operations with proven leadership in early-phase studies.
Experience in metabolic or related therapeutic areas strongly preferred.
Ability to thrive in a fast-paced, resource-conscious environment.
Hands-on approach with strategic vision-comfortable building processes from the ground up.
This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.
$200k-250k yearly 2d ago
Associate Director, Clinical Operations
EPM Scientific 3.9
Boston, MA jobs
Base Salary: $145K-$215K USD + Bonus | Full-Time | Remote
A fast-growing, clinical-stage biotech is redefining treatment paradigms with cutting-edge bispecific antibody therapies for immune and inflammatory disorders. Backed by strong investors and powered by a lean, agile team, this company is on a mission to deliver transformative biologics for patients with complex immune-mediated conditions. Be part of a team where innovation meets purpose-and help shape the next generation of therapies.
Key Responsibilities
Lead and oversee global Phase I-III clinical trials across immunology and inflammatory indications.
Manage CROs and specialty vendors, ensuring adherence to GCP, ICH, and regulatory standards.
Own budgets, timelines, and risk mitigation plans for all clinical programs.
Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality teams.
Drive inspection readiness and ensure audit preparedness.
Qualifications
Minimum 8 years of clinical operations experience in biotech/pharma, including 3+ years in a leadership role.
Proven track record managing global trials and CROs.
Strong knowledge of GCP, ICH, and regulatory requirements.
Immunology or inflammatory disorder experience preferred.
If you or someone you know fits this experience and shows interest, we'd love to speak with you!
$145k-215k yearly 5d ago
Associate Director, HCP Marketing, Rare Disease
Ipsen 4.9
Cambridge, MA jobs
Ipsen's Rare Disease franchise has been expanding through both organic growth and acquisitions. From a marketing standpoint, there is a critical need for excellence in strategic planning and in execution to clearly define how we will best drive education of appropriate healthcare providers, deliver successful launches, and win in highly competitive spaces.
The AssociateDirector, HCP Marketing, PBC is a key role on the Rare Disease Commercial Team and will report to the Iqirvo Brand Lead. The AD will support US marketing initiatives and key promotional activities to help the Rare team achieve near-term revenue goals and support the ongoing successful launch of Iqirvo. Responsibilities will encompass traditional HCP marketing including brand planning, development of materials and messages for multichannel engagement focused on congresses, advisory boards, peer to peer educational programs and KOL engagements. The role will include execution of both personal and non-personal promotional tactics.
The AD will collaborate with the Thought Leader Engagement Team, Field leadership, Sales training, Medical Affairs, Legal & Business Ethics to execute tactics focused on HCP Marketing.
Main Responsibilities & Job Expectations:
Core Marketing Activities
Lead key initiatives to implement tactical HCP Marketing plan
Development & execution congress marketing plans & materials
Speaker bureau content strategy, training, execution & ongoing management
Advisory board planning and execution
Amplify peer to peer messaging through multichannel engagement tactics
Develop and monitor KPIs for brand tactical plan and communicate performance vs leading and lagging indicator to Rare disease leadership
Contribute to Brand Planning and Tactical Plan development for Iqirvo
Ensure compliant execution of all promotional activities
Collaborate with:
Rare disease field leadership to provide support with sales force execution and gain feedback and insights to adjust and enhance materials / messages
Other brands teams within marketing to ensure cohesive delivery of portfolio strategy and unified external voice to customers
Thought Leader Liaison team & Sales Leadership on marketing material development, execution and performance
Promotional review committee to ensure compliant development of field resources in line with the strategy
Business ethics & legal team to ensure compliant development and implementation of projects
Cross Functional Collaboration & Stakeholder Management:
Incorporate insights from primary and secondary research into development of field promotional tactics
Share leadership responsibilities for regular cross-functional meetings including congress planning, bureau operations and brand team meetings
Work with advanced analytics to ensure appropriate understanding and implementation of brand strategy.
Knowledge, Abilities & Experience:
BA/BS is required: PharmD or MBA preferred
At least 10 years of experience in commercial pharmaceutical roles, with a minimum of 5 years in marketing
Successful launch experience in the rare of specialty categories, hepatology would be a strong plus
Excellent leadership, strategic planning, and project management skills
Proven track record of developing and executing successful healthcare professional (HCP)marketing strategies
Strong understanding of the rare disease landscape and patient needs
Excellent communication and interpersonal skills along with the ability to influence others
Ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously
Strong analytical skills with the ability to interpret data and make informed decisions
Knowledge of the AMA, ACCME, PhRMA and FDA regulations associated with promotion and industry-supported scientific education activities
Able to work from our Cambridge, MA HQ on a hybrid model including 2-3 days in office
Willingness to travel, including international, when needed
The annual base salary range for this position is $151,500 to $222,000
This job is eligible to participate in our short-term incentives program. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
$151.5k-222k yearly 5d ago
Director/Senior Director, Analytical Development
EPM Scientific 3.9
New York, NY jobs
Head of Analytical Development: NYC
We are seeking a Director or Senior Director of Analytical Development to lead and expand the analytical development function. This individual will play a pivotal role in supporting late-stage programs, ensuring robust analytical strategies for drug substance and drug product, and driving method development, validation, and transfer activities.
This is a hands-on leadership role for someone who thrives in a dynamic environment, enjoys rolling up their sleeves, and is committed to building best-in-class analytical capabilities. The ideal candidate will be comfortable commuting to the New York site four days per week and collaborating cross-functionally with CMC, Quality, and external partners.
Key Responsibilities
Lead the Analytical Development team responsible for method development, qualification, validation, and transfer for drug substance and drug product.
Develop and implement analytical strategies to support late-stage development, scale-up, and commercialization.
Oversee characterization studies, stability programs, and specification setting in alignment with regulatory requirements.
Partner closely with Process Development, Quality, and Regulatory teams to ensure seamless integration of analytical deliverables.
Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met.
Provide technical leadership and mentorship to a growing team, fostering a culture of scientific excellence and accountability.
Contribute to regulatory submissions (IND, NDA) and represent Analytical Development in health authority interactions as needed.
Qualifications
Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
10+ years of experience in analytical development within the biotech or pharmaceutical industry, with a strong focus on small molecule late-stage development and commercialization.
Proven track record of leadership in method development, validation, and transfer for complex modalities (biologics experience strongly preferred).
Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for global filings.
Excellent communication and collaboration skills; ability to work effectively in a fast-paced, matrixed environment.
Willingness and ability to be onsite in New York 4 days per week.
Why Join?
Opportunity to shape analytical strategy for a late-stage pipeline with high-impact programs.
Work in a well-funded biotech with strong pharma partnerships and a clear path to commercialization.
Collaborative, science-driven culture where your contributions make a tangible difference.
$129k-189k yearly est. 1d ago
Executive Director, Corporate Legal Counsel
Crinetics Pharmaceuticals, Inc. 3.9
San Diego, CA jobs
Executive Director, Corporate Legal Counsel page is loaded## Executive Director, Corporate Legal Counselremote type: Hybrid-San Diegolocations: San Diego, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR000519**Salary Range**The salary range for this position is: $281,000 - $351,000.*In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*
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$101k-168k 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.
$55k-110k yearly est. 5d 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. 5d ago
Associate Director, Commercial Training & Field Effectiveness
Akebia Therapeutics 3.7
Cambridge, MA jobs
AssociateDirector, Commercial Training & Field Effectiveness LinkedIn Twitter Email Message Share
Commercial Operations
Cambridge, MA * ID: 25R-32 * Full-Time/Regular
Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
Job Summary
Reporting to the Sr. Director of Commercial Excellence, the AssociateDirector of Field Engagement and Effectiveness is responsible for gathering field insights regarding launch effectiveness requirements, developing commercial & sales training programs and delivering operational support to the customer-facing roles. This will include disease state, product/therapeutic landscape knowledge, compliance (OIG), and other commercialization processes and systems. The incumbent will need to collaborate across Medical, Marketing, Sales, Market Access, Legal, People and Culture, Regulatory, and other Partner Organizations.
Training (50% of the time)
Aligning to Akebia's annual strategy for sales and marketing focus
Develop a sales training curriculum that motivates customer-facing personnel to achieve their goals and align with the strategy.
Establish a collaborative, clinical, sales focused learning environment with core principles of adult learning
Optimize curriculum that allows ongoing education for customer-facing teams to ensure consistency in disease state and product knowledge. (product/non-product training modules)
Lead and coordinate new hire onboarding and training programs for customer-facing teams.
Collaborate with Subject Matter Experts (SMEs) to create the appropriate learning content for the respective customer-facing role.
Direct Field Trainers who will be peer-to-peer trainers with their colleagues within the sales team.
Liaise with home office/field management about the development and delivery of training material.
Document and maintain proper records of training initiatives.
Collaborate with the administration of the Promotional, Medical, Legal, & Regulatory (PRC) process to identify the training requirements and the delivery of material for use.
Support efforts in Company meeting planning and execution, including agenda creation, workshop development, and delivery as well as overall meeting facilitation for POAs & NSMs.
Manage vendors and partners to produce meaningful curriculum within established scope and timeframes.
Perform additional responsibilities and participate in special projects as assigned.
Field Effectiveness Insight Generation (30% of the time)
Work with Sales Leadership Team to review team effectiveness with the aim of identifying performance gaps and create sales tactics and/or training programs to address them.
Interpret sales data and KAM call information to develop appropriate training reinforcement and development plans.
Perform ride along with KAMs to provide feedback on promotional effectiveness, customer engagement and territory management.
Develop and implement KAM feedback tool to provide written feedback to KAMs to highlight performance attributes affecting promotional success.
Develop and manage feedback from sales organization on key initiatives
Engagement Effectiveness Administration (20% of the time)
Manage Learning Management System (Akebia Learning) partnering closely with Compliance, Commercial and Human Resources
Participate in the implementation/deployment of technologies (Veeva CRM, Sales portal) to be used by the field force to increase efficiency, and effectiveness and determine the best way to train the team.
Requirements
Bachelor's degree required.
8+ years' experience in a commercial role within a pharma or biotech company and at least 5 years in a sales/product training-focused role.
Previous Experience in building a sales training continuum for a life science company
Proficient in Microsoft Office Suite, including PowerPoint, Excel, and Word
Proficient in sales reporting and analytics tools (e.g., Tableau), as well as CRM and Learning Management Systems (LMS)
Demonstrated experience with best-in-class means of training delivery including eLearning, self-study, assessment, audio/video, classroom, and experiential learning to ensure the sales force is trained and can deliver the attributes of our products.
Strong interpersonal, presentation and facilitation skills required.
Previous field sales experience is strongly preferred.
Demonstrated success in managing numerous projects simultaneously.
Ability to challenge the thinking of an established customer facing team.
Requires 15-35% travel.
Compensation:
Targeted Base: $171,290 - $211,593*
*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.
Are you an Akebian?
An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: **************
Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.
RequiredPreferredJob Industries
Other
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit****************************** more information.
The AssociateDirector (AD), Market Access Marketing - Sleep will support the Sleep Franchise team with a remit of optimally positioning Jazz products to enable patient access in an increasingly challenging and evolving US access landscape.
The AD, Market Access Marketing - Sleep will report to and primarily function as strategic support to the Director, Market Access Marketing - Sleep and lead the tactical execution in support of brand strategy. The AD is responsible for the implementation of the payer value proposition and promotional/non-personal tools and tactics for use with third party payers. In addition, this individual will work cross-functionally with various field teams including Payer Account teams, Field Access and Reimbursement teams, and Field Sales teams to ensure they are equipped with programs, tools, resources, and messaging to optimize customer engagement and ensure patient access.
Key Responsibilities
Strategic Thinking: Think strategically across indications to identify opportunities to align and further complement efforts to maximize value communication
Brand Plan Execution: Work with the marketing team and other stakeholder functions to execute and refine brand tactical plan with the goal of driving both awareness and perception of access among target audiences; participate in the development and execution of the annual brand planning process. Build, coordinate, and orchestrate a cross-functional view of full market access activities and activations
Value Communication: Craft compelling payer value propositions, messaging platforms, and tools that resonate with key stakeholders including payers, providers, healthcare decision-makers
Resource Development: Create innovative tools and materials (e.g., pull through materials, resource guides, AMCP dossiers, value decks, field training modules) to support field teams in effectively communicating product value and outcomes
Cross-Functional Collaboration: Partner with Market Access, HEOR, Medical Affairs, Regulatory, Compliance, Brand Marketing, and Sales teams to align access strategies and ensure consistent execution
Insight Generation: Conduct primary and secondary research, analyze relevant data, and monitor competitive and market trends to generate meaningful payer/HCP insights for use in business decision-making
Performance Measurement: Lead the development and coordination of performance measurement and reporting across responsible assets and KPIs to ensure access messaging is effectively delivering on brand access objectives
Qualifications
Bachelor's degree required; advanced degree (MBA, MPH, PharmD) preferred
7+ years of combined experience in pharmaceutical marketing, market access, or related field
4+ years of experience in Market Access Marketing, Patient Support Services, and/or Payer Account Management
Deep understanding of the U.S. healthcare landscape, including payer dynamics and reimbursement pathways
Thorough understanding of processes to develop and obtain approval of promotional materials, including navigating Medical, Regulatory, and legal reviews
Strong communication, analytical, and project management skills
Ability to thrive in a fast-paced, matrixed environment
Pharmaceutical career progression that demonstrates growth in responsibility and scope, particularly in commercial Market Access positions
The position will be primarily home based, with the expectation that the person is willing to travel to meetings as necessary
Preferred
Specialty pharmaceutical Market Access related experience
Specialty/retail pharmaceutical Marketing related experience
#LI-Remote
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $162,400.00 - $243,600.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: *********************************************
RequiredPreferredJob Industries
Other
$162.4k-243.6k yearly 19d ago
Associate Director, Capital Projects
Cambrex 4.4
Homestead, IA jobs
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview The AssociateDirector of Capital Projects is responsible for the strategic planning, execution, and oversight of capital projects at the CDMO site.
This role provides leadership for project management, engineering design, procurement, construction, and validation of facilities, utilities, and manufacturing equipment.
The position ensures that all projects meet regulatory compliance requirements (cGMP, FDA, OSHA), are delivered on time and within budget, and align with business goals and operational excellence initiatives.
Responsibilities Lead the planning and execution of site capital projects from concept through handover, ensuring quality, safety, cost, and schedule objectives are met.
Develop and manage multi-million-dollar capital budgets and resource plans in collaboration with site leadership and global engineering teams.
Oversee cross-functional teams including engineering, validation, quality, procurement, and operations personnel to ensure project alignment with site needs.
Act as the primary liaison with external architects, engineers, contractors, and regulatory authorities for capital initiatives.
Ensure all projects comply with GMP, environmental, health and safety (EHS), and regulatory requirements.
Provide technical leadership in facility design, utility systems (HVAC, WFI, clean steam), and process equipment implementation.
Drive risk management strategies, contingency planning, and change control processes throughout project lifecycles.
Prepare and present project updates, metrics, and risk assessments to senior management and stakeholders.
Mentor and develop junior and experienced project engineers to support a high-performance project team.
All employees are required to adhere to OSHA, DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
All employees are expected to report to work regularly and promptly.
Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications/Skills Strong knowledge of GMP regulations, validation practices, and pharmaceutical production processes.
Proficient in project management tools (MS Project, Primavera, etc.
) and capital planning software.
Excellent communication, negotiation, and leadership skills.
Ability to work collaboratively in a fast-paced, matrixed environment.
Education, Experience & Licensing Requirements Bachelor's degree in Engineering, Construction Management, or a related field required; Master's degree preferred.
Minimum of 10 years of experience in capital project execution within the pharmaceutical, biotech, or CDMO industry.
At least 5 years in a leadership or managerial capacity overseeing cross-functional project teams.
Demonstrated experience managing complex capital projects ($10M+) in a regulated manufacturing environment.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
#LI-RD1Bachelor's degree in Engineering, Construction Management, or a related field required; Master's degree preferred.
Minimum of 10 years of experience in capital project execution within the pharmaceutical, biotech, or CDMO industry.
At least 5 years in a leadership or managerial capacity overseeing cross-functional project teams.
Demonstrated experience managing complex capital projects ($10M+) in a regulated manufacturing environment.
Lead the planning and execution of site capital projects from concept through handover, ensuring quality, safety, cost, and schedule objectives are met.
Develop and manage multi-million-dollar capital budgets and resource plans in collaboration with site leadership and global engineering teams.
Oversee cross-functional teams including engineering, validation, quality, procurement, and operations personnel to ensure project alignment with site needs.
Act as the primary liaison with external architects, engineers, contractors, and regulatory authorities for capital initiatives.
Ensure all projects comply with GMP, environmental, health and safety (EHS), and regulatory requirements.
Provide technical leadership in facility design, utility systems (HVAC, WFI, clean steam), and process equipment implementation.
Drive risk management strategies, contingency planning, and change control processes throughout project lifecycles.
Prepare and present project updates, metrics, and risk assessments to senior management and stakeholders.
Mentor and develop junior and experienced project engineers to support a high-performance project team.
All employees are required to adhere to OSHA, DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
All employees are expected to report to work regularly and promptly.
Other duties relating to departmental mission, not specifically detailed in this section may be assigned.