A leading pharmaceutical company in Boston is seeking an experienced Associate Director to lead training initiatives within the Oncology team. The role involves developing comprehensive training programs and collaborating with sales leaders to enhance team capabilities. Candidates should have a strong background in pharmaceutical sales, preferably in oncology, along with leadership and project management skills. This position offers a competitive salary and a hybrid work environment.
#J-18808-Ljbffr
$112k-207k yearly est. 5d ago
Looking for a job?
Let Zippia find it for you.
Director, New Product Planning and Business Development Forecasting, Global Oncology
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description Director, New Product Planning and Business Development Forecasting, Global Oncology Takeda Pharmaceutical Cambridge, MA About the role:
The Director will be a key strategic though partner to the business development and new product planning teams in creating forecasts for pipeline assets and Business Development (BD) opportunities within Takeda's Oncology Business Unit (OBU).
The individual will perform strategic market analysis for pipeline assets and BD opportunities through the integration of secondary healthcare data analytics, competitive intelligence, and primary market research, and other data inputs to create quantitative insights and facilitate key business decisions. As part of this role, the individual will be interacting regularly with working with cross functional team across commercial, clinical, medical, and access/pricing teams to perform asset evaluations.
The individual will be interacting with senior leadership of the Oncology business unit to present commercial potential and will also work closely with team members from US, Japan, and EU. The individual is expected to be able to regularly synthesize key analytical outputs in management-ready deliverables to help inform and drive strategic business decisions. In addition to strong therapeutic area knowledge, the individual is expected to have a strong grasp of incorporating insights across market research, competitive intelligence and secondary data analytics to drive the commercial assessment.
How you will contribute:
Ensure that customized, global, strategic forecasts are developed for pipeline assets and BD opportunities with assumptions based on facts and research
Collaborate with team members from commercial/NPP, market research, analytics, competitive intelligence, global pricing and market access, to make sure all relevant market insights inform the forecasts.
Lead the consensus‑building process to gain alignment and/or endorsement for forecast assumptions with the senior stakeholders and Oncology Leadership Team (OLT)
Leverage advanced analytics and integrate data available across multiple sources to enhance our understanding of market impact of the assets being considered
Lead development, training and dissemination of Long Range Forecasting and applicable templates and management summaries for all relevant oncology products to regions and local operating companies of the Oncology Business Unit
Leverage advanced analytics and integrate data available across multiple sources to enhance our understanding of market impact and as a result, Takeda's brand and business strategy.
Lead identification, maintenance, and generation of data references/databases, analogs for continuously improving oncology epidemiology and other forecast inputs, across markets
Create forecasts that are range based, identifying key risk and opportunities of the brands/assets under consideration
Serve as a strategic thought partner to the commercial/NPP teams and other key stakeholders as they work through the strategy to accelerate pipeline assets and evaluate BD opportunities
Manage and supervise a team of Takeda resources and vendors (onshore & offshore team) to deliver on key priorities
Minimum Requirements/Qualifications:
BA/BS degree, Advanced degree preferred.
Minimum of 10 years of relevant experience in forecasting, market research, or business analytics in the biopharmaceutical industry.
Significant experience conducting complex assets valuations in a fast‑paced environment.
Experience with advanced spreadsheets, patient based forecast modeling including dynamic patient models
Experience in business development forecasting, preferred
Experience in oncology, solid tumors, hem tumors or similar specialty areas
Experience with quantitative techniques including smoothing, regression, time series analyses, and simulation. Experience with data analysis and data visualization tools.
Product launch and Global experience. Consulting experience with forecasting, market research or business analysis firm(s)
Broad working knowledge of commonly used biopharmaceutical industry databases
Working knowledge of global access and reimbursement policies, and competitive environment and potential impact on product development and commercialization strategy
Ability to facilitate large meetings and influence senior stakeholders
Ability to work collaboratively in a team‑based environment, including external vendors
Demonstrated excellence in project management and effectively managing multiple projects/priorities.
Exceptional oral and written communications skills with the capacity to present effectively to a diverse range of audiences.
Ability to explain complex concepts to stakeholders in simple language and lead/drive consensus building
Demonstrated analytical skills combined with a client‑service mindset
Demonstrated ability to think strategically, identify key issues and value drivers, and translate strategic insights into an appropriate analytical framework.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as “hybrid” in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#J-18808-Ljbffr
$174.5k-274.2k yearly 6d ago
Hybrid: Global Regulatory Data & Systems Leader
Takeda 4.7
Remote or Boston, MA job
A leading global biopharmaceutical company is seeking a Head of Global Regulatory Information, Data and Systems to develop and implement a comprehensive strategy. This pivotal role involves guiding a team, ensuring regulatory data integrity, and driving system adoption. The ideal candidate has 15+ years of experience in regulatory affairs and data systems, along with a bachelor's degree. The position is hybrid based in Boston, MA, with an attractive salary range between $208,200 and $327,140, plus benefits.
#J-18808-Ljbffr
A global biopharmaceutical leader is seeking an Associate Director, Clinical and Safety Quality Compliance in Cambridge, MA. This hybrid role is pivotal for ensuring the quality of processes and product outputs in compliance with regulations. Candidates should have a BSc in a relevant field, over 7 years of experience in pharma, and strong project management and communication skills. If you're looking to contribute to impactful clinical initiatives, apply now.
#J-18808-Ljbffr
$128k-194k yearly est. 5d ago
Sales Representative - Primary Care - Columbus, Ohio
Shionogi 4.4
Columbus, OH job
The Sales Representative (SR) for Primary Care is responsible for promoting and selling primary care product(s) to healthcare providers, driving sales performance in alignment with business goals within the assigned territory. This includes driving demand, clinical education and sales by developing, coordinating, and implementing a strategic business plan for Primary Care Physicians.
The position reports to the District Manager and will collaborate closely with Marketing, Market Access, and other internal partners, as appropriate, to drive sales results. The span of coverage will be within the Columbus, Ohio territory.
This role requires strong interpersonal skills, a deep understanding of the healthcare market, and the ability to meet and exceed sales targets.
Responsibilities
Effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients
Function independently with sales proficiency to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations
Build and develop professional relationships with (but not limited to) primary care healthcare professionals, pharmacy staff, within assigned customers and territory
Develop and maintain in-depth knowledge of market, demographic, and managed care information relative to assigned territory
Drive appropriate utilization of approved primary care product(s); the incumbent will work closely with cross-functional partners to generate pull-through within local payers, community HCPs, etc.
Work with District Sales Manager and Regional Sales Director to develop a local strategy and business plan to generate high-performing sales in assigned territory
Capitalize on formulary approvals and other opportunities through effective implementation of targeting plans by using a wide variety of promotional, digital, personnel resources and analytical tools to enhance effectiveness in assigned sales territory, based on local assessment of customer needs.
Leverage expertise and knowledge of primary care marketplace, applicable competitors, industry and cross-functional activities/plans to anticipate and effectively manage business opportunities and challenges
Provide special education to healthcare providers through appropriate programs that fall within Shionogi's guidelines
Provide relevant, thoughtful input to other commercial colleagues (e.g. sales leadership, regional account managers) in regard to strategic and tactical planning for territory, area, and region
Prioritize time and effort to ensure optimal coverage of appropriate physician targets based on opportunity and potential through in-person and virtual discussions
Understand fully the assigned customers' product and business needs and works to meet those needs while adhering to all of Shionogi company ethics and compliance standards
Anticipate potential barriers to achievement of goals and proposes responsible solutions for success
Handle customer objections effectively and exceed customer expectations with the value they bring to physicians. Occasionally will be called on to share your exemplary skills with others in the region in a training capacity
Leverage and embrace emerging technologies to enhance performance, while continuously striving to improve your proficiency
Understand and comply with pharmaceutical industry guidelines and regulations and apply high ethical standard in day-to-day work
Minimum Job Requirements
Qualifications
BS/BA degree required
Minimum 3+ years of experience in pharmaceutical, medical device preferred or related transferrable sales experience
Proven track record of consistent high performance in a sales-focused role or other relevant experience
Proven track record in developing long-standing relationships with customers
Ability to work independently and manage multiple clients
Strong understanding of the primary care market and healthcare industry highly preferred
Demonstrated ethical behavior and compliance with company policies and applicable laws
Knowledge of the medical, healthcare or pharmacy industry and skills in clinical is preferred
Product launch experience is a plus
Knowledge of territory and relationships with key stakeholders already established is a plus
Proficiency in Veeva CRM, Microsoft Teams, Outlook, and calendar-based call planning tools is a plus
Marketing and other commercial experiences with an understanding of financial processes, Market Access, Project Management skills and knowledge of the Regulatory environment within biotech/pharma industry is a plus
Competencies
Possess strong written, organization, administrative and communication skills
Excellent judgment and decision-making skills
Excellent presentation and negotiation skills
Proven ability to receive effective feedback and redirect performance
Results oriented with demonstrated time management skills
Ability to learn, analyze, understand and convey complex information
Ensures compliance with all corporate and industry policies and regulations
Effective prioritization, flexibility and change management in a dynamic environment
Focuses on customer excellence; actively seeks to discover and meet the needs of internal and external customers by building relationships and delivering innovative solutions
Develops positive and mutually beneficial relationships internally, to meet and exceed all Company access goals
Proactively takes ownership of situations with a can-do approach
Advanced business analytical skills to identify trends opportunities and threats
Ability to problem solve and determine actions to drive business or overcome challenges
Ability to utilize corporate reporting tools and technology or overcome challenges
Ability to utilize corporate reporting tools and technology
Other Requirements
Ability to comply with any customer credentialing and safety requirements (e.g., up-to-date vaccinations, trainings)
Complete full onboarding curriculum including clinical modules, CRM documentation, and call standards
Pass live call certification and mock objections during training
Attend refresher meetings on product and disease-state updates
Significant field travel (approximately 80%) which can include some overnight and/or weekend work
Valid driver's license with a clean driving record and ability to pass a complete background check
Must have valid licenses and credentialing required to conduct business in assigned territory
Driving in a safe manner to required meetings and appointments
Ability to drive or fly to target accounts, customers, meetings and conventions
Additional Information
The base salary range for this full-time, field-based position is $110,000-$140,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, vehicle allowance, bonus, long-term incentive, or any additional compensation that may be associated with this role.
EEO
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling ************ or by sending an email to ***********************.
$110k-140k yearly Auto-Apply 11d ago
Research Scientific Director, Large Molecule AI Development
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.
We are seeking a strategic, visionary Research Scientific Director to lead the next generation of AI/ML-enabled biologics discovery at Takeda. This senior leadership role has two primary mandates:
Drive AI/ML application to accelerate and de-risk large-molecule pipeline projects Build and scale AI/ML platform capabilities as a core competitive advantage for biologics discovery.
You will be a key leader within the AI/ML organization, setting strategy, building partnerships across R&D, and delivering measurable impact on our biologics portfolio. You will be accountable for converting state-of-the-art AI/ML science into validated, production-grade decision tools that change how Takeda discovers, designs, and optimizes large-molecule therapeutics.
This role requires a leader who can operate at multiple altitudes, defining long-term vision and roadmaps while also ensuring scientific rigor, technical depth, and operational excellence in execution.
Key Responsibilities
1. AI/ML Application to Pipeline Projects
Drive the AI/ML strategy for antibody and other large-molecule discovery programs from target assessment through lead optimization.
Ensure AI/ML activities are aligned with program and portfolio goals, with clear milestones, timelines, and success criteria.
Deliver production-grade decision tools (for example, variant ranking, developability risk flagging, zero-shot design) that are seamlessly integrated into discovery workflows.
Act as a hands-on technical leader across multiple programs:
Define modeling strategies and architectures
Prioritize methods and experiments
Review and challenge scientific output for quality and robustness
Partner with Discovery Platform Heads and project leaders to embed AI/ML milestones into program plans, stage-gates, and decision forums (discovery, engineering, mult-specifics)
2. AI/ML Platform Build and Innovation
Define and own a multi-year platform roadmap for large-molecule AI/ML capabilities, including models, tools, data assets, and infrastructure.
Lead the development and deployment of foundational models for antibody and protein sequence, structure, and function prediction.
Drive integration of physics-based methods (for example, MD, FEP, docking) with machine learning approaches to create hybrid models with improved accuracy and generalization.
Own data strategy for large-molecule AI/ML (data requirement, quality standard, governance)
Partner closely with engineering, computational, and laboratory teams to ensure the platform is usable, reliable, and scalable across programs and sites
3. Leadership, Talent, and Culture
Build, mentor, and retain a high-performing, multidisciplinary team of scientists and engineers.
Provide clear goals, expectations, and development paths and ensure high standards of scientific excellence and reproducibility.
Champion an inclusive, collaborative, and learning-oriented culture that values curiosity, rapid iteration, and rigorous validation.
Communicate complex AI/ML concepts and results clearly to non-experts, including project teams and senior leadership, enabling data-driven decision-making.
Qualifications
Required:
PhD degree in Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years relevant experience
Proven track record of leading AI-driven projects in a research pharmaceutical setting.
Significant depth of expertise in at least one field relevant to the job (for example, machine learning, biotherapeutic design, etc.).
Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction.
Significant depth of expertise in at least one relevant area, such as:
Machine learning or deep learning
Protein or biotherapeutic design
Structural modeling or computational biophysics
Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute both individually and through teams
Versatile communicator who can explain complex ideas to non-specialists and influence diverse stakeholders
Preferred:
Experience leading teams that integrate machine learning with physics-based modeling (for example, MD, FEP, docking)
Experience building or owning AI/ML platforms or foundational models used across multiple programs
Prior leadership of cross-functional initiatives spanning discovery biology, protein engineering, and data or engineering teams
ADDITIONAL INFORMATION
The position will be based in Cambridge, MA. This position is currently classified as “hybrid” by Takeda's Hybrid and Remote Work policy
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly Auto-Apply 37d ago
2026 U.S Summer Internship Program: Data Scientist Computational Biology Intern
Takeda 4.7
Remote or Cambridge, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
The intern in the Early Clinical Development (ECD) computational biology group at Takeda GI-TAU will implement and test machine learning/deep learning based methods, to integrate and analyze large screening datasets and metadata information to generate actionable insights and interpretation for drug discovery and development questions in Gastrointestinal & Inflammation Therapeutic Area
How You Will Contribute:
As a Computational Biology Intern, you will have the opportunity to…
Leverage proprietary clinical multi-omics data assets and implement advanced AI/ML approaches.
Explore and experiment with innovative strategies for data integration, visualization, and analytical approaches.
Engage in the exploration of cutting-edge methodologies aimed at enhancing the precision and depth of analyses.
Contribute to the development of advanced techniques within the field of Precision Medicine and Biomarker Discovery.
Job Requirements:
This position will be Fully Remote out of the Round Lake, Illinois location
Must be pursuing a Doctoral Degree in Computational Biology, Bioinformatics, Biostatistics and any other relevant fields.
Familiar with machine/deep- learning frameworks/libraries. Experience in testing and implement different deep learning architecture is preferred
Strong programming skills in R/Python. Proficiency in Unix/Linux shell, AWS/HPC environment is preferred
Working knowledge in molecular biology and clinical metadata
Highly motivated with a strong interest in bioinformatics data analysis in drug discovery and development
Quick learner, Outstanding oral and written communication skills.
Internship Eligibility
Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
Must be currently enrolled in a degree program graduating December 2026 or later
The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
The intern must be able to commit to one of these time frames
Able to work full time 40 hours a week during internship dates
Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
Program Highlights:
Hands-on experience with real projects and responsibilities
Dedicated mentorship program pairing interns with experienced professionals
Networking opportunities with industry professionals and fellow interns
Internship events focused on professional and skills development
Exposure to multiple business areas or departments within a Pharmaceutical Organization
Applications will be accepted between October 31st- November 16th
Takeda Compensation and Benefits Summary
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Cambridge - Binney St
U.S. Hourly Wage Range:
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
Paid sick time
Civic Duty paid time off
Participation at company volunteer events
Participation at company sponsored special events
Access to on-site fitness center (where available)
Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - Cambridge - Binney StWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$21-46 hourly Auto-Apply 60d+ ago
2026 U.S Summer Internship Program: Data Scientist Computational Biology Intern
Takeda Pharmaceuticals 4.7
Remote or Cambridge, MA job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
The intern in the Early Clinical Development (ECD) computational biology group at Takeda GI-TAU will implement and test machine learning/deep learning based methods, to integrate and analyze large screening datasets and metadata information to generate actionable insights and interpretation for drug discovery and development questions in Gastrointestinal & Inflammation Therapeutic Area
**How You Will Contribute:**
As a Computational Biology Intern, you will have the opportunity to...
+ Leverage proprietary clinical multi-omics data assets and implement advanced AI/ML approaches.
+ Explore and experiment with innovative strategies for data integration, visualization, and analytical approaches.
+ Engage in the exploration of cutting-edge methodologies aimed at enhancing the precision and depth of analyses.
+ Contribute to the development of advanced techniques within the field of Precision Medicine and Biomarker Discovery.
**Job Requirements:**
+ This position will be Fully Remote out of the Round Lake, Illinois location
+ Must be pursuing a Doctoral Degree in Computational Biology, Bioinformatics, Biostatistics and any other relevant fields.
+ Familiar with machine/deep- learning frameworks/libraries. Experience in testing and implement different deep learning architecture is preferred
+ Strong programming skills in R/Python. Proficiency in Unix/Linux shell, AWS/HPC environment is preferred
+ Working knowledge in molecular biology and clinical metadata
+ Highly motivated with a strong interest in bioinformatics data analysis in drug discovery and development
+ Quick learner, Outstanding oral and written communication skills.
**Internship Eligibility**
+ Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
+ Must be currently enrolled in a degree program graduating December 2026 or later
+ The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
+ The intern must be able to commit to one of these time frames
+ Able to work full time 40 hours a week during internship dates
+ Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
** ** **Program Highlights:**
+ Hands-on experience with real projects and responsibilities
+ Dedicated mentorship program pairing interns with experienced professionals
+ Networking opportunities with industry professionals and fellow interns
+ Internship events focused on professional and skills development
+ Exposure to multiple business areas or departments within a Pharmaceutical Organization
**Applications will be accepted between** **October 31** **st** **- November 16** **th**
**Takeda Compensation and Benefits** **Summary**
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - MA - Cambridge - Binney St
**U.S. Hourly Wage Range:**
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
+ Paid sick time
+ Civic Duty paid time off
+ Participation at company volunteer events
+ Participation at company sponsored special events
+ Access to on-site fitness center (where available)
+ Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - MA - Cambridge - Binney St
**Worker Type**
Employee
**Worker Sub-Type**
Paid Intern (Fixed Term) (Trainee)
**Time Type**
Full time
**Job Exempt**
No
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$21-46 hourly 60d+ ago
Rebate Associate (Manager Level), Commercial Contracts, US Oncology
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:
As a member of Takeda Oncology your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Patient Value and Access team, you will report to the Contracting Operations Lead and work with key stakeholders.
Perform calculations and generate payments in compliance with executed reimbursement Agreements and maintain all assigned account responsibilities.
Assist in the identification and development of information and process requirements. Consult with managers and key stakeholders to make well-informed decisions, drive process improvement and other initiatives. Provide support for data governance, business process management, and assist in the performance and maintenance of controls, data quality, and accuracy.
Understand business and operational strategies and processes, respond to data requests with appropriate information and analysis. Respond to routine business, systems, and data questions, and assist the team with problem resolution. Assist as needed with routine variance analysis to ensure data completeness and payment accuracy. Conduct research and provide training and guidance as needed.
Provide support for the management and coordination of data and information resources. Maintain an inventory of policy, procedure, training, and other documentation. Support the development of standard reporting and other metrics as required. Support all compliance and audit reviews.
Coordinate resources to support for cross-functional projects and activities.
How you will contribute:
Perform all the functions required for the management and administration of assigned accounts. Ensures all pertinent contract attributes are properly translated into the correct contract set-up in the rebate payment system. Ensures the accuracy, integrity, and timeliness of all payments for Commercial and Medicare Part D contracted customers, including rebates, fees and chargebacks. This process includes the interpretation and translation of contract language, ensuring formulary/benefit compliance, data validation and rebate calculations. Adhere to all audit requirements and any/all reporting regulations as defined within Takeda's policies and guidelines related to rebate processing.
Gain a thorough understanding of contract terms and requirements and respond to non-routine questions and data problems. Coordinate with internal teams to bring all issues to a satisfactory resolution.
Gather Payer claim level data files, reconcile Payer invoices and perform detailed payment analysis to ensure contract compliance and rebate payment accuracy. GPO roster reconciliation, GPO sales volume reconciliation, run superlist performance reports, and calculate rebates. Maintain trading partners and process rebates and fees within ModelN FLEX revenue management system for both Payer and GPO contracts. Support data requests from US OBU Patient Value & Access field team, Distribution, Data Stewards, and IT, as well as external parties including Payers and GPOs.
Supports all Commercial and Medicare Part D internal/external audits by preparing and providing the necessary documentation to Director, Commercial Contracting Operations
Assists with the implementation of system and/or process improvements to develop more efficient business processes. Provide production support testing of new system enhancements, defects or new programs. Performs all system user acceptance testing for any systems that support the rebate payment process. This also includes working with IT on updating test scripts.
Assists Commercial Contracting Managers with updating rebate training manual and other supporting materials (i.e., quality control checklists).
Minimum Qualifications/Requirements:
Bachelor's degree or 4 years contracts and pricing experience required.
2+ years of rebate processing experience in the pharmaceutical industry required.
ModelN/Flex Revenue Manager experience in contract implementation and maintenance preferred.
Experience with various commercial contracting price protection methodologies preferred.
Ability to think through how decisions will impact Takeda, customers and stakeholders prior to execution.
Strong critical thinking and problem solving skills.
Strong verbal and written communication skills.
Must demonstrate excellent organization and time-management skills.
Ability to handle multiple projects and tasks in a matrix environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$111,800.00 - $175,670.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$111.8k-175.7k yearly Auto-Apply 60d ago
Director, Global Quality Systems (DMS & LMS)
Takeda 4.7
Remote or Lexington, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role
As Director, Global Quality Systems (DMS & LMS), you will serve as the enterprise Business System Owner for Takeda's Document Management System (DMS) and Learning Management System (LMS). You you will drive the design, implementation, and deployment of the DMS & LMS electronic systems. You will be expected to navigate highly complex, cross-functional challenges-balancing compliance, business needs, and technological innovation-while remaining sufficiently hands-on to understand system configurations, investigate issues, and support end users when needed. As the business owner of these critical quality systems, you will play an essential part in advancing Takeda's digital quality landscape. Takeda is fully leaning into the capabilities and promise of AI and digital advancement, and we are looking for a Director who is motivated by exploring innovation within the pharmaceutical environment. Your leadership will help transform our Global Quality organization by encouraging innovative thinking and delivering scalable, future-ready digital solutions.
How you will contribute
Lead the implementation, enhancement, and lifecycle management of enterprise DMS and LMS solutions, ensuring alignment with global standards, GxP requirements, and Takeda's quality management framework.
Provide senior leadership for highly complex issues, acting as the primary escalation point for systemic problems, inspection/audit observations, and cross-functional decision making related to DMS and LMS.
Translate business needs into robust technical and process solutions, collaborating closely with IT, Quality, Manufacturing, R&D, and Commercial to design efficient, compliant workflows and integrations.
Maintain a strong hands-on understanding of the systems, including configuration, data structures, user roles, and interfaces, enabling you to guide troubleshooting, support complex user issues, and validate technical proposals.
Define and govern business processes and procedures related to document and learning management, ensuring effective system integration, regulatory controls, training curricula, and data integrity.
Lead change at enterprise scale, leading change management initiatives, major system upgrades, and migrations/retirements, and ensuring that business needs, data requirements, and impact on users are fully addressed.
Establish and oversee governance forums and user communities, fostering knowledge sharing, user engagement, and continuous improvement through regular meetings, communications, and feedback loops.
Monitor and continuously improve system performance and inspection readiness, using metrics and analytics to proactively address risks, strengthen compliance, and enhance user experience.
Drive digital innovation and automation, partnering with internal and external experts to explore AI, advanced analytics, and other emerging technologies that can modernize quality practices and reduce manual effort.
Represent Global Quality Systems with senior stakeholders, aligning priorities, managing expectations, and influencing decisions that affect Takeda's global quality and digital ecosystem.
What you bring to Takeda
A strategic, innovative mindset with the ability to shape and execute a long-term vision for global quality systems while delivering tangible, short-term improvements.
Extensive experience in the pharmaceutical or biotech industry, with deep knowledge of GxP regulations, global quality standards, and inspection expectations related to document and learning management.
Proven leadership in enterprise-level DMS and/or LMS ownership, including strategy, implementation, and ongoing governance.
Ability to operate at both strategic and hands-on levels-comfortable engaging with senior leaders on risk and investment decisions, and equally comfortable diving into system details, data issues, and complex user problems.
Strong analytical and problem-solving skills, capable of diagnosing process and system gaps, balancing compliance and efficiency, and implementing effective, scalable solutions.
Demonstrated success in leading through change in a complex, global environment-able to influence without authority, build consensus, and guide diverse stakeholders through digital and process transformation.
Excellent communication and collaboration skills, with experience working across functions, geographies, and cultures, and translating technical topics into clear business language.
A track record of promoting digitalization, data quality, and innovative thinking, ideally including AI, automation, and data-driven decision making in quality or GxP contexts.
Experience in a large, global pharma or biotech company; background from a top-20 global pharmaceutical organization is a strong plus.
Commitment to Takeda's core values, including patient focus, trust, reputation, and business excellence, and a genuine passion for improving how quality is delivered through modern digital systems
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly Auto-Apply 51d ago
Associate Director, Scientific Training Lead, Global Medical Affairs Oncology
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:
As a member of Takeda Oncology, your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Head of Medical Excellence & Scientific Training.
Responsible for identification of learning needs, development and execution of strategic, tailored training plans and packages, and measurement of training success for Medical Affairs Scientific Training plans within GMAO, which includes ongoing needs assessments, developing and updating training programs, and establishing reinforcement training, including booster and focal training, to drive continual enhancement of GMAO scientific knowledge of Takeda Oncology marketed and pipeline products, relevant disease states, and competitor data
Ensure strategic collaboration with regions and countries to better understand training needs and deliver programs that meet these needs
Work with and oversee vendors to help support training initiatives.
Serve as a subject-matter expert and consultant to the regions and countries within GMA
Liaise with members of the GMAO team and key cross-functional stakeholders such as Global Outcomes Research, and be a key contributor to the successful operations of the GMAO Medical Capabilities department
How you will contribute:
Perform baseline and ongoing assessments to identify training needs, and to develop tailored training packages and plans to address those needs
Lead development and updating of high-quality medical affairs education and training plans and materials to drive a consistent and deep understanding of, scientific knowledge on, and communication fluency with, Takeda Oncology products, respective disease states, and competitor data aligned with product scientific platforms
Develop and execute GMAO on-boarding training programs for Disease and Product data, and ensure GMAO teams across regions and countries are trained and certified as scientific experts on Takeda Oncology products
Collaborate with the Head of Medical Excellence and Scientific Training to implement training systems/platforms, as appropriate, to facilitate ease of training; deliver innovative training that maximizes multiple learning approaches including, but not limited to, modules/slides, e-learning, webinars, live meetings, workshops, and posters
Collaborate with the Oncology Business Unit (OBU) regions and countries to build, customize, and use, tools and systems that enable improved GMAO and regional interactions, which will foster a cohesive culture and allow for deeper learning
Identify and engage internal or external speakers, as appropriate, to deliver topic‑specific expertise
Become a subject matter expert on Takeda Oncology products and act as a resource for countries and regions to provide scientific expertise
Ensure compliance with all relevant SOPs, policies, and procedures
Minimum Requirements/Qualifications:
Doctoral degree (PhD, PharmD) in a scientific discipline with a minimum of 5 years of healthcare or related experience, inclusive of 3+ years of experience in medical affairs and/or training
Master's degree in a scientific discipline with a minimum of 8 years of healthcare or related experience, inclusive of 6+ years of experience in medical affairs and/or training
Experience with oncology
Experience working with cross-function teams
Vendor management experience
Strong communication, prioritizing, problem-solving, planning, and organizational skills
Experience with training
Preferred:
Experience in Medical Affairs or Clinical Development, and in adult education, is strongly preferred
Prior curriculum development, and experience with educational outcome assessment, and application of adult learning principles
Significant experience in pharmaceutical or biomedical writing and communications, including group facilitation and presentation to diverse audiences
Experience with learning management systems
Broad product/disease area knowledge
Experience using influence and negotiation to secure positive outcomes
Travel requirements
Ability to travel up to 25% per year including international travel
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$168,700.00 - $265,100.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$168.7k-265.1k yearly Auto-Apply 45d ago
CDMO-CTO Management Strategy and Operations Director
Takeda 4.7
Remote or Lexington, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
CDMO-CTO Management Strategy and Operations Director
OBJECTIVES/PURPOSE:
The Strategy and Operations Director owns the alignment of the supply base to PharmSci's short and long-term goals. The Director works to maximize our organization's efficiency and effectiveness by standardizing our processes to manage external partners and the engagement of our internal stakeholders. Works in close coordination and collaboration with CDMO-CTO Relationship Managers, the functions, and shared services (such as procurement, legal, and finance) to achieve Takeda's objectives.
Support alignment of strategic supplier base with our network strategies, Future Fit, Digital Readiness, and Innovation needs working closely with each PharmSci R&D function (Drug Product & Device Development, Analytical Development, Biologics Process Development, Synthetic Molecules Process Development, and Program Leadership)
Develop and maintain CDMO-CTO Management's Vendor Network Strategy through continuous governance and evaluation of performance, effectiveness and strategic fit of vendors selected.
Continually optimize and socialize CDMO-CTO Relationship Management operating model and standardize our supplier-centric processes to maximize our efficiencies with our engagements with internal stakeholders (PharmSci Technical functions, Legal, Finance, Procurement, and Global Manufacturing Services) and our strategic external suppliers.
Create and maintain necessary GXP documentation and trainings on operating model
Support the ongoing management and oversight of existing critical vendors including performance management, KPIs, business/financial risk evaluations, and governance
ACCOUNTABILITIES:
Represent CDMO Management on strategic initiatives such as clinical manufacturing site selection and capacity planning. Develop strategies to reduce the external manufacturing footprint by 10% year over year.
Align the global vendor network strategies across categories, regions and business functions (including but not limited to Global Manufacturing Services, Global Procurement, Global Clinical Supply Chain, Legal)
Develop a framework to capture network vendor performance through fit-for-purpose KPIs, translating to dashboards and operationalize a solution to enable continuous network optimization
Build and manage a strategic road map across People, Process and Systems to standardize work and improve efficiency across CDMO-CTO team and the wider PharmSci teams
Act as business process standardization and optimization SME. This includes: manage vendor governance meeting charters, templates and procedures; create, update and maintain procedures and processes for CDMO-CTO Relationship Management; update and socialize CDMO-CTO team operating model; update and optimize Site Selection process, inventory management etc.
Help identify, onboard, and then manage the business relationship of our new and existing strategic suppliers in line with functional and network strategies.
Establish a strategy to import CDMO data into Takeda's data fabric to enable aspirational digital innovation
Build / drive an optimal usage of existing system solutions to allow centralized production visibility across the internal and external vendor base, ensure inventory compliance, enable lot genealogy and provide an interface with finance, global clinical supply chain and technical functions.
Plan and maintain a rolling annual calendar of vendor governance meetings (Business Review Meetings - BRMS, Joint Steering Committees - JSC etc) with CDMOs, CTOs and Medical Device suppliers and support internal vendor network governance meetings as well as manage engagement at trade shows like DCAT and CHPI,
Provide support to Product Operating Model (POM) as required
Create and maintain standardized processes for site selection, vendor performance review and governance to be utilized by CDMO Relationship Managers and socialize within Pharm Sci
Serve on Pharmaceutical Sciences cross-functional workstreams as CDMO Management SME and represent teams responsibilities and strategies
CORE ELEMENTS RELATED TO THIS ROLE:
Establish strong relationships with team members and internal stakeholders to facilitate operating model awareness and consistency
Work closely with PharmSci Leads, Analytical development, Device Development Leads, , and other internal business partners (Procurement, Finance, Legal, Global Manufacturing Sciences) to proactively identify program / portfolio risks and develop robust mitigation and contingency plans
Proactively identify, action, or elevate internal and external supplier issues and conflicts in a professional and timely manner
Partner with Takeda stakeholders to select among existing or develop new CDMOs who can meet program requirements and augment Takeda's internal or external manufacturing network capabilities
Establish clear and consistent supplier governance models to ensure clear lines of communication, meeting cadence, and escalation paths
Establish and support global network / supplier strategies that align with PharmSci R&D function needs and expectations, short and long term strategies
Ability to critically review, process and understand complex business challenges, provide potential solutions
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Bachelor Degree in Engineering, Biotechnology, Business or scientific field. MBA or Masters Degree preferred.
Minimum of 10-15 years relevant clinical/commercial drug, device, and/or combination product Pharmaceutical experience
This position is currently classified as “hybrid” by Takeda's Hybrid and Remote Work policy
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly Auto-Apply 56d ago
Associate Director, Global Clinical Supply Chain Operations
Takeda 4.7
Remote or Lexington, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Clinical Supply Chain Operations in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver
Better Health and a Brighter Future
to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
POSITION OBJECTIVES:
The Associate Director, GCSC Operations is responsible for providing leadership and direction to facilitate the planning and execution of GCSC activities globally. Under the direction of the GCSC Director, the Associate Director manages Clinical Supply project delivery in support of Takeda Global R&D Clinical Trials and other supportive research or development needs; coordinates, procures and manages drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction activities of clinical trial material.
Works with both internal and external customers and suppliers to develop and communicate clinical supply project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner.
Provides expertise, collaborates internally and leads Global Clinical Supply Chain group initiatives including the active participation of the study oversight process for Global Clinical Supply Chain activities.
POSITION ACCOUNTABILITIES:
Works with GCSC Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines, and budgets.
Utilizes the Smart Supplies Database (PMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality. Understands IRT standards and PMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
Interfaces with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of clinical trial material for shipment to sites.
Interfaces with Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported with in progress stability programs, and/or appropriate expiry dating.
Works closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.
Works with GCSC Specialists to manage and troubleshoot shipment requests, drug returns, SmartSupplies, and IRT processes. Works with them to ensure creation and maintenance of project documentation and according to established procedures and to manage clinical trial material inventory for projects assigned.
Oversees and coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with service providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Takeda.
Key interface with Clinical Operations and Regulatory Affairs on all information required for Health Authority Submissions.
Evaluate and propose system improvements and technology enhancements/opportunities.
Manages and oversees external consultants and third-party vendors, including vendor selection and agreement development, to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements. Ensures that key project milestones are met across multiple programs; negotiates and communicates supply plan timelines to internal and external customers, partners and GCSC leadership team.
Accountable and responsible for amending budgets through defined change management processes. Manages all finance activities with clinical team including request for proposal for bidding and vendor selection, purchase orders and invoice approval. Responsible for forecasting for materials, costs and managing variances across multiple programs with multiple late phase protocols.
Coaches and mentors less experienced staff.
Evaluate current processes, identify, and implement improvement opportunities and implement business processes related to the Clinical Supplies Team as required.
Manages specialized or high profile projects
Serves as a back up to the director when needed
Effectively leads workstream to support departmental initiatives and goals
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Degree in Pharmacy, other scientific/technical degree, or significant job-related experience.
Minimum of 8 years relevant Pharmaceutical Industry and/or Contract/Service Provider experience is preferred.
Experience with oncology a plus.
Strong understanding of cGMP requirements
Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus
This position is currently classified as “ hybrid” in accordance with Takeda's Hybrid and Remote Work policy.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
#LI-JV2
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U.S. Base Salary Range:
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$153.6k-241.3k yearly Auto-Apply 2d ago
Research Scientific Director, Large Molecule AI Development
Takeda Pharmaceutical Company Ltd. 4.7
Remote or Boston, MA job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.
We are seeking a strategic, visionary Research Scientific Director to lead the next generation of AI/ML-enabled biologics discovery at Takeda. This senior leadership role has two primary mandates:
Drive AI/ML application to accelerate and de-risk large-molecule pipeline projects Build and scale AI/ML platform capabilities as a core competitive advantage for biologics discovery.
You will be a key leader within the AI/ML organization, setting strategy, building partnerships across R&D, and delivering measurable impact on our biologics portfolio. You will be accountable for converting state-of-the-art AI/ML science into validated, production-grade decision tools that change how Takeda discovers, designs, and optimizes large-molecule therapeutics.
This role requires a leader who can operate at multiple altitudes, defining long-term vision and roadmaps while also ensuring scientific rigor, technical depth, and operational excellence in execution.
Key Responsibilities
1. AI/ML Application to Pipeline Projects
* Drive the AI/ML strategy for antibody and other large-molecule discovery programs from target assessment through lead optimization.
* Ensure AI/ML activities are aligned with program and portfolio goals, with clear milestones, timelines, and success criteria.
* Deliver production-grade decision tools (for example, variant ranking, developability risk flagging, zero-shot design) that are seamlessly integrated into discovery workflows.
* Act as a hands-on technical leader across multiple programs:
* Define modeling strategies and architectures
* Prioritize methods and experiments
* Review and challenge scientific output for quality and robustness
* Partner with Discovery Platform Heads and project leaders to embed AI/ML milestones into program plans, stage-gates, and decision forums (discovery, engineering, mult-specifics)
2. AI/ML Platform Build and Innovation
* Define and own a multi-year platform roadmap for large-molecule AI/ML capabilities, including models, tools, data assets, and infrastructure.
* Lead the development and deployment of foundational models for antibody and protein sequence, structure, and function prediction.
* Drive integration of physics-based methods (for example, MD, FEP, docking) with machine learning approaches to create hybrid models with improved accuracy and generalization.
* Own data strategy for large-molecule AI/ML (data requirement, quality standard, governance)
* Partner closely with engineering, computational, and laboratory teams to ensure the platform is usable, reliable, and scalable across programs and sites
3. Leadership, Talent, and Culture
* Build, mentor, and retain a high-performing, multidisciplinary team of scientists and engineers.
* Provide clear goals, expectations, and development paths and ensure high standards of scientific excellence and reproducibility.
* Champion an inclusive, collaborative, and learning-oriented culture that values curiosity, rapid iteration, and rigorous validation.
* Communicate complex AI/ML concepts and results clearly to non-experts, including project teams and senior leadership, enabling data-driven decision-making.
Qualifications
Required:
* PhD degree in Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years relevant experience
* Proven track record of leading AI-driven projects in a research pharmaceutical setting.
* Significant depth of expertise in at least one field relevant to the job (for example, machine learning, biotherapeutic design, etc.).
* Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction.
* Significant depth of expertise in at least one relevant area, such as:
* Machine learning or deep learning
* Protein or biotherapeutic design
* Structural modeling or computational biophysics
* Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute both individually and through teams
* Versatile communicator who can explain complex ideas to non-specialists and influence diverse stakeholders
Preferred:
* Experience leading teams that integrate machine learning with physics-based modeling (for example, MD, FEP, docking)
* Experience building or owning AI/ML platforms or foundational models used across multiple programs
* Prior leadership of cross-functional initiatives spanning discovery biology, protein engineering, and data or engineering teams
ADDITIONAL INFORMATION
* The position will be based in Cambridge, MA. This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly 37d ago
Long-Term Care (LTC) Sales Account Manager - Ohio East
Shionogi & Co., Ltd. 4.4
Columbus, OH job
The Long-Term Care (LTC) Sales Account Manager is responsible for establishing access and generating demand in targeted LTC settings, including but not limited to Skilled Nursing Facilities, Nursing Homes, and LTC Pharmacies within an assigned territory. This role involves identifying and developing strategic business relationships with key decision makers and influencers (e.g. prescribing HCPs, Consultant Pharmacists, LTC Facility Medical Directors, LTC Pharmacy Directors, Directors of Nursing, Nursing Staff, Administration), understanding their needs and educating targets on clinical value and appropriate use of our product(s) to generate demand. This role will also be responsible for establishing and maintaining relationships with LTC affiliated provider association, advocacy groups and professional service providers.
This role will cover the Ohio East territory. Ideal living locations for this position include Cleveland, OH and Columbus, OH.
Responsibilities
* Effectively and consistently call on LTC facilities and affiliated business entities daily through one-on-one meetings and presentations, professional education programs and other appropriate means, targeting HCPs (MDs/NPs), Medical Directors, Administrators, DONs, consultant pharmacists, and pharmacy directors to educate on clinical profile, access process, and appropriate utilization.
* Responsible for executing and tracking a high level of call and field productivity; expected to meet and exceed expectations for target number of account and customer calls per day.
* Analyze territory information and insights to develop and execute effective target mapping, account plans, optimize routing, and maximize field resources to achieve results.
* Establish professional relationships and maintain an effective communication network with the customer at multiple levels, including HCPs (MDs/NPs), Medical Directors, Administrators, DONs, consultant pharmacists, and pharmacy directors.
* Develop and implement sales strategies to achieve sales targets and expand access and utilization.
* Execute brand sales strategies to ensure a consistent company marketing message.
* Manage and grow existing accounts within the long-term care sector.
* Partner with reimbursement and market access team to proactively address patient access issues.
* Perform Company business in accordance with all regulations (i.e., PDMA/Sample), Company policy and procedures. Demonstrates high ethical and professional standards at all times.
* Maintain comprehensive call documentation, access barriers, and response metrics in Veeva CRM.
* Responsible for accurately reporting field activities, territory expenses and submitting written reports as necessary by the deadline set forth and defined by Shionogi management.
* Maintain accurate records of sales activities, customer interactions, and market feedback.
* Identify and communicate field issues, opportunities and competitive activities through appropriate organizational venues. Escalate emerging trends in utilization gaps, drop-offs, or prescriber feedback.
* Collaborate with Regional Account Management, Market Access, Medical Affairs, and Marketing on all needs and opportunities, customer touch points, and changes.
* Represent the company at LTC-focused medical/pharmacy association events.
* Create opportunities for product education while enhancing Shionogi's image and commitment to medicine, working directly with local/regional thought leaders and professional societies.
* Appropriately manage and maintain all company equipment and promotional materials (company literature, computer, etc.) according to necessary company guidelines.
* Actively pursue continuous learning and professional development on efficient sales, communication, managed care and product knowledge training.
* Attend all company-sponsored meetings as directed by company management (POAs, National Meetings, National/Regional Conventions, etc.). In-person attendance may be required according to most current company policy.
* Maintain a deep understanding of the company's products, industry trends, and competitor activities.
* Provide exceptional customer service and support to ensure customer satisfaction and loyalty.
Minimum Job Requirements
Qualifications
* Bachelor's Degree (BA or BS).
* Minimum of seven (7) years of sales experience in the pharmaceutical or healthcare industry, experience selling in long-term care is required.
* Experience calling on SNFs, ALFs, LTC pharmacies, or consultant pharmacist networks.
* Experience selling in a complex reimbursement and access environment.
* In-depth understanding of the pharmaceutical industry, product launch strategies, and long-term care market and practices including pharmaceutical product review.
* Experience in building rapport and relationships within the long-term setting in order expand awareness and utilization of product(s) and make an immediate impact on healthcare professionals.
* Ability to understand and navigate long-term care systems in order to gain access to key decision makers.
* Proficiency in Veeva CRM, Microsoft Teams, Outlook, and calendar-based call planning tools.
* Business to business experience and/or ability to demonstrate strong influencing skills.
* Documented record of demand generation, performance and achievement in Long Term Care
* Successful long-term care launch experience is a required.
Competencies
* Excellent oral, presentation and written communication skills.
* Strong clinical acumen with the ability to communicate clinical data in order to demonstrate competence and communication of a high-level scientific product.
* Strong organizational, interpersonal and listening skills.
* Thrives in an ever-changing environment.
* Ability to work independently and collaborate internally as a team member to deliver results.
* Proactive; can do approach, takes ownership of situations.
* Demonstrated self-starter, highly motivated, problem-solving skills.
* Digital competence; ability to deliver presentations digitally using iPad.
* Proficient in MS Office Suite; Word, PowerPoint, Excel and Outlook.
* Tact, diplomacy, and a high level of professionalism are essential.
Other Requirements
* Complete full onboarding curriculum including clinical modules, CRM documentation, and fair balance call standards.
* Pass live call certification and mock objections during ride-along training.
* Attend refresher meetings on disease-state updates, HUB workflows, and patient retention strategy.
* Significant field travel (approximately 80%).
* Driving in a safe manner to required meetings and appointments.
* Valid driver's license with a clean driving record and ability to pass a complete background check.
* Must have valid licenses and credentialing required to conduct business in assigned territory.
* Ability to drive or fly to target accounts, customers, meetings and conventions.
* Some overnight and/or weekend travel may be required.
Additional Information
The base salary range for this full-time, field-based position is $135,000-$175,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.
EEO
Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.
If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling ************ or by sending an email to ***********************.
$19k-39k yearly est. 40d ago
Senior Manager, Global Regulatory Labeling Strategy - Remote
Takeda 4.7
Remote or Massachusetts job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of assigned product(s) in various stages of drug development, which may include products of medium complexity and updates to TLP, CCDS, USPI and EU SmPC. You will also be responsible for providing support to the development and implementation of labeling content and strategy of high complexity product(s).
How you will contribute:
With appropriate supervision and guidance:
Management of Labeling Cross-Functional Teams
Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, for assigned product(s), with appropriate supervision and guidance.
Assists in the development of labeling strategies and content and to ensuring cross-functional alignment for other medium and/or high complexity products.
Interface with Senior Management Cross-Functional Team (GLOC)
Coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels, with appropriate supervision, guidance and alignment with TAU/MPD Labeling Lead.
Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.
Labeling Documents Authoring, Submission, and Labeling Negotiations
Authors revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation, with appropriate supervision and guidance.
With appropriate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs.
Authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance.
Employs project management skills to interface with global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and participates in label negotiations with Health Authorities.
Ensures labeling content conform to regulatory requirements.
Management of Local Exceptions and LOC Interactions
Manages the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance.
Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc.
Escalation Process and Stakeholder Management
Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.
Proactively strengthen and foster robust relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure highly effective communication of labeling strategy and content.
Precedent Search and Labeling Trends
Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals.
Working within Labeling Team and GRA
Represents Global Labeling at Global Regulatory Team (GRT)
Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.
Participates in departmental and cross-functional task-forces and initiatives.
Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products.
Support in Managing Labeling Deliverables for Medium and/or High Complexity Products
Assist in managing high complexity products by working with GLLs and labeling management on assigned labeling tasks such as review and edit labeling documents, assist in leading LWG meetings, coordinate labeling local update / exception process etc.
Vendor Management
Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
Minimum Requirements/Qualifications:
BSc degree, preferred; BA accepted.
Advanced scientific degree (MSc, PhD, or PharmD) preferred.
6+ years of pharmaceutical industry experience. This is inclusive of 4 years of labeling experience or combination of 4+ years regulatory and/or related experience.
Knowledge of US and EU product labeling regulatory requirements and guidelines.
Familiarity with US and/or EU regulatory requirements and guidelines.
Familiarity with other relevant regional regulatory nuances and requirements.
Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development.
Ability to co-author, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions with appropriate supervision and guidance.
Ability to identify factors and requirements necessary for regulatory recommendations.
Ability to develop regulatory strategies based on regulatory requirements and competitive landscape.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - Virtual
U.S. Base Salary Range:
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$137k-215.3k yearly Auto-Apply 60d+ ago
Global Ethics & Compliance Investigations Head, Americas
Takeda 4.7
Remote or Cambridge, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:
The Global Ethics & Compliance Investigations Head, Americas, senior director level, leads the team that reviews and investigates allegations of misconduct and/or potential violations of laws, regulations, or Company policies across North and South America.
This role involves leading, managing, and developing talent on the Americas investigations team; planning and conducting thorough investigations; preparing and presenting detailed findings to senior stakeholders; and collaborating cross-functionally to identify, mitigate, and remediate identified risks.
As part of the Global Ethics & Compliance team, this role will report to the Global Head of Ethics & Compliance Investigations.
How you will contribute:
Be a core contributor to the development, enhancement, and implementation of a comprehensive enterprise-level global investigations program. Incumbent owns the Investigation Process in Americas for Takeda, adapting it in response to regulatory, technological or organizational shifts.
Assess concerns and allegations in the Americas region to determine if an investigation is warranted
Oversee case distribution, and provide guidance, mentoring, and oversight to direct reports
Prepare investigation plans and conduct thorough investigations into compliance and regulatory issues. Incumbent runs Tier-1 investigations and deals with sensitive cases and stakeholders. This role interacts with Legal Litigations team to hand over for legal action as needed.
Prepare and present detailed investigation reports to different levels of organization, including executive level
Collaborate across all BU/BF with Legal, Ethics & Compliance, HR, business functions, and other departments to identify root cause(s) and mitigate or remediate risks that impact Takeda, beyond the investigations function
Ensure adherence to applicable laws, regulations and company policies
Provide training and guidance on investigations and compliance matters.
Proactively identify opportunities to mitigate company risk through training and sharing of case studies/ best practices
Provide regular reporting on investigation trends and takeaways to the Head of Global E&C Investigations, Head of Governance, Risk & Compliance Program, the Chief Ethics & Compliance Officer, and other senior leaders and executives
Represent Global Investigations in different cross-functional forums, ensuring consistency and compliance in the investigation's cases across Americas.
Capabilities:
Strategic and pragmatic approach to investigations, including the ability to make timely decisions in ambiguous situations with limited information
Impeccable integrity, sound and independent judgment, discretion, and finesse in handling sensitive matters/information
Highly skilled in cross-functional collaboration as well as with external consultants and experts
Demonstrated ability to proactively develop and continuously enhance an Investigations Program, including its framework, processes, and governance
Strong personal and business acumen to build strong relationships at all levels in the organization and to navigate and manage complex stakeholder interactions effectively
Ability to interpret, contextualize and apply rules, guidelines, policies, procedures, and controls
Takes initiative, works independently, and appropriately prioritizes work on multiple cases/projects
Minimum Requirements/Qualifications:
10+ years of hands-on experience managing sensitive and complex investigations in the United States is required; additional international investigations experience in Central / South America is preferred
A graduate degree (i.e., JD, MBA) and/or a professional credential (i.e, CPA, CFE, CCEP) is required
Proven track-record in leading teams and planning and executing corporate investigations as outside counsel, in-house legal, compliance, or audit professional, and/or as an enforcement agency prosecutor; prior experience in the pharmaceutical or medical device industry is required
Deep knowledge of the laws, regulations, and industry codes relevant to the healthcare industry in North & South America (e.g., FCPA, SOX, False Claims Act, Antikickback Statute, PhRMA Code, DOJ Guidelines for Corporate Compliance Programs), as well as their real-world application and enforcement
Proficiency in English is required; additional language proficiency in Spanish and/or Portuguese is preferred
Legal, compliance, audit, or risk-management background is highly preferred
Strong analytical, problem-solving, and communication skills
Ability to work independently and handle sensitive information with discretion is required
Experience managing sensitive and complex investigations in the United States and internationally, including cases of fraud, harassment, and corruption, amongst others
Travel Requirements:
Ability to travel domestically / internationally up to 15% as required to perform investigations
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Cambridge, MA
U.S. Base Salary Range:
$208,200.00 - $327,140.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$208.2k-327.1k yearly Auto-Apply 11d ago
Associate Director, PI HCP Marketing
Takeda 4.7
Remote or Cambridge, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:
This is an exciting time for the Plasma Derived Therapies business unit, Immune Deficiency and Neuromuscular franchise! Join our launch team as Associate Director, HCP Marketing, where you will be a key leader responsible for helping develop the strategic direction of our newest addition to the IG portfolio as we prepare for a best-in-class launch in PI. This role is highly visible and important, as its remit will span all HCP marketing stakeholders and channels. Working closely with our customer engagement colleagues, you will develop and execute tactics likely including but not limited to personal and non-personal promotion, search, professional engagements, and congress presence. Success in the role will depend on effective cross-functional partnership and collaboration. You will also leverage data and insights to inform the decision-making processes and ensure that our strategies are rooted in deep understanding of HCPs' needs and behaviors. You will accomplish all of this through a focus on the end goal of winning for patients. You will report to the Director, USBU PDT Launch Lead.
How you will contribute:
Partner with the Launch Lead in developing:
- Positioning: brand personality, differentiation, brand pillars
- Campaign: core creative platform, research to inform concept selection
Be the daily lead in the implementation of all HCP pull-through marketing, partnering with multiple internal stakeholders and external agencies.
Partner with SCIG brand team to ensure clarity in brand differentiation.
Partner with Insights & Analytics to sharpen portfolio strategy with this new brand entrant. Distill insights, validate business opportunities, optimize channel mix, and educate HCPs.
Own strategically aligned engagement plans and tactics ensuring successful execution. Collaborate with brand and franchise teams to launch:
- HCP and Access marketing resources
- HCP fee-for-service plan and pull through (advisory boards, speaker pro grams, consulting)
- P2P strategy and resource development
- National and regional congress plans, including exhibit design/strategy, symposia/product theater content, KOL engagements
- Regional marketing resources as appropriate
Recognize industry/competitive trends to identify brand growth opportunities and identify industry and internal best practices to build organizational capability
Manage multiple agencies from strategic brief ideation through to delivery, holding them accountable to Takeda USBU policies, standards, timelines and budgets
Oversee the direction and deliverables of multiple priorities ensuring internal stakeholder alignment, across agency partners, and cross functional partners including PRT, medical affairs, compliance, and IT
Minimum Requirements/Qualifications:
Bachelor's degree
8+ years' experience with increasing responsibilities in sales, marketing or related function
4+ years of dedicated experience engaging with HCPs
Foster collaboration, and enable teamwork
Set priorities, develop roles and responsibilities, and manage external partners
Deep understanding of a brand/franchise strategy and how to effectively engage HCPs; have a strong understanding of business, finance and risks/benefits of decisions
Experience in marketing strategy and tactic design with an ability to communicate ideas to internal colleagues and external partners
Broad-based HCP Marketing knowledge from non-personal (e.g., designing/running a CRM program) to field sales (e.g., managing deployment of assets)
Leverage data and analytics to distill insights and drive data-based decision making
Comfortable with emerging technologies, adaptability to digital tools, and openness to AI-enabled processes.
Preferred:
MBA
Pharmaceutical industry experience
Experience working on a product launch
Experience in PDT, particularly Primary Immunodeficiency
Experience developing engagement plans for thought leaders / key opinion leader management and ability to comfortably liaise with these customers
Travel:
Requires approximately 25-40% travel, which includes travel to Cambridge, MA office
Ability to travel to various internal and external meetings and conferences that could include overnight stays ranging from one to several nights.
Some weekend travel may be required.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Cambridge - Kendall Square - 500
U.S. Base Salary Range:
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - Cambridge - Kendall Square - 500Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$153.6k-241.3k yearly Auto-Apply 60d+ ago
Research Scientific Director, Large Molecule AI Development
Takeda Pharmaceuticals 4.7
Remote or Boston, MA job
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.
The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you.
We are seeking a strategic, visionary Research Scientific Director to lead the next generation of AI/ML-enabled biologics discovery at Takeda. This senior leadership role has two primary mandates:
**Drive AI/ML application to accelerate and de-risk large-molecule pipeline projects** **Build and scale AI/ML platform capabilities as a core competitive advantage for biologics discovery.**
You will be a key leader within the AI/ML organization, setting strategy, building partnerships across R&D, and delivering measurable impact on our biologics portfolio. You will be accountable for converting state-of-the-art AI/ML science into validated, production-grade decision tools that change how Takeda discovers, designs, and optimizes large-molecule therapeutics.
This role requires a leader who can operate at multiple altitudes, defining long-term vision and roadmaps while also ensuring scientific rigor, technical depth, and operational excellence in execution.
**Key Responsibilities**
**1. AI/ML Application to Pipeline Projects**
+ Drive the AI/ML strategy for antibody and other large-molecule discovery programs from target assessment through lead optimization.
+ Ensure AI/ML activities are aligned with program and portfolio goals, with clear milestones, timelines, and success criteria.
+ Deliver production-grade decision tools (for example, variant ranking, developability risk flagging, zero-shot design) that are seamlessly integrated into discovery workflows.
+ Act as a hands-on technical leader across multiple programs:
+ Define modeling strategies and architectures
+ Prioritize methods and experiments
+ Review and challenge scientific output for quality and robustness
+ Partner with Discovery Platform Heads and project leaders to embed AI/ML milestones into program plans, stage-gates, and decision forums (discovery, engineering, mult-specifics)
**2. AI/ML Platform Build and Innovation**
+ Define and own a multi-year platform roadmap for large-molecule AI/ML capabilities, including models, tools, data assets, and infrastructure.
+ Lead the development and deployment of foundational models for antibody and protein sequence, structure, and function prediction.
+ Drive integration of physics-based methods (for example, MD, FEP, docking) with machine learning approaches to create hybrid models with improved accuracy and generalization.
+ Own data strategy for large-molecule AI/ML (data requirement, quality standard, governance)
+ Partner closely with engineering, computational, and laboratory teams to ensure the platform is usable, reliable, and scalable across programs and sites
**3. Leadership, Talent, and Culture**
+ Build, mentor, and retain a high-performing, multidisciplinary team of scientists and engineers.
+ Provide clear goals, expectations, and development paths and ensure high standards of scientific excellence and reproducibility.
+ Champion an inclusive, collaborative, and learning-oriented culture that values curiosity, rapid iteration, and rigorous validation.
+ Communicate complex AI/ML concepts and results clearly to non-experts, including project teams and senior leadership, enabling data-driven decision-making.
**Qualifications**
**Required:**
+ PhD degree in Computational Biology, Bioinformatics, Computer Science, or a related field with 10+ years relevant experience
+ Proven track record of leading AI-driven projects in a research pharmaceutical setting.
+ Significant depth of expertise in at least one field relevant to the job (for example, machine learning, biotherapeutic design, etc.).
+ Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction.
+ Significant depth of expertise in at least one relevant area, such as:
+ Machine learning or deep learning
+ Protein or biotherapeutic design
+ Structural modeling or computational biophysics
+ Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute both individually and through teams
+ Versatile communicator who can explain complex ideas to non-specialists and influence diverse stakeholders
**Preferred:**
+ Experience leading teams that integrate machine learning with physics-based modeling (for example, MD, FEP, docking)
+ Experience building or owning AI/ML platforms or foundational models used across multiple programs
+ Prior leadership of cross-functional initiatives spanning discovery biology, protein engineering, and data or engineering teams
**ADDITIONAL INFORMATION**
+ The position will be based in Cambridge, MA.This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Boston, MA
**U.S. Base Salary Range:**
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Boston, MA
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$174.5k-274.2k yearly 36d ago
Director, Regulatory Site CMC
Takeda 4.7
Remote or Boston, MA job
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities-including small molecules, biologics, and external manufacturing sites-the role employs an agile approach to drive standardization, scalability, and sustainability.
This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes.
We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
How you will contribute:
Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements.
Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes.
Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities.
Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.
Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings.
Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.
Promote sustainable practices and scalability in site-level regulatory operations.
Minimum Requirements/Qualifications:
BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred.
10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA.
Strong practical experience with global HA requirements, beyond EU/US.
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
Analyze issues with attention to detail.
Ability to assess alternative approaches.
Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines.
Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management.
Understands who is responsible for different decisions and escalates as necessary.
Applies directions taken by the company.
Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
Intentionally promotes an inclusive culture.
Applies given prioritization framework with limited support.
Excellent written and oral communication skills required.
Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.
#LI-Hybrid
#LI-AA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Zippia gives an in-depth look into the details of Aytu BioPharma, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Aytu BioPharma. The employee data is based on information from people who have self-reported their past or current employments at Aytu BioPharma. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Aytu BioPharma. The data presented on this page does not represent the view of Aytu BioPharma and its employees or that of Zippia.
Aytu BioPharma may also be known as or be related to AYTU BIOSCIENCE INC, AYTU BIOSCIENCE, INC, Aytu BioPharma, Aytu BioScience, Aytu BioScience, Inc. and Aytu Bioscience, Inc.