Associate Director, Statistics (Statistical Science Lead, Safety)
Executive director job at Astellas Pharma
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex/novel work in an established area (safety/clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project), This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques.
The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS or the Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the position can act as global safety statistical lead for a late phase or novel asset or represent Astellas on statistical matters related to safety data, clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position may also research innovative solutions and train other statisticians.
Essential Job Responsibilities:
Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs. For assigned projects, provides all required safety statistical support and deliverables by supervising another statistician, or as a member of study team.
* Ensures quality and consistency of key safety data science deliverables.
* Accountable for the Asset Level Safety Assessment Plan (ALSAP).
* For early or non complex asset, independently provides strategic safety statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs ) including design of studies and analyses requiring advanced statistical methodologies.
* Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose.
* Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results.
* Presents summary data and analyses to key stakeholders in a compelling and clear manner
* Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.
* May participate in due diligence activities, reviews safety data and advises company
* Is responsible to implement, explain and validate complex safety statistical methodology
Personal Development / Collaboration
* Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value
* Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards - selection and qualification/audits of vendors)
* Contributes to the recruitment, training, professional development and retention of statistical personnel.
* is a member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation.
Executive Director of Regulatory Ad/Promo
Bridgewater, NJ jobs
Title: Executive Director of Regulatory Affairs Ad/Promo
A global health care company, dedicated to improving people's lives through innovative solutions specialized in pharmaceuticals, medical devices, and over-the-counter products is looking to bring on an Executive Director of Regulatory Affairs Ad/Promo to join their team! The Ad/Promo team is rapidly growing, and they are looking for someone to come in and provide their expertise, based out of their New Jersey office. This role will give you an amazing opportunity to contribute to the company's mission to enrich lives by delivering better health outcomes.
The Executive Director will be responsible for…
Review Ad/Promo materials, new campaigns, and launch strategies for assigned products to ensure regulatory compliance. Ensure timely and accurate evaluation to meet deadlines and requirements
Develop and implement regulatory strategies and solutions to ensure all ad/promo material comply with regulatory requirements and company policies
Monitor FDA activities, including enforcement actions and guidance documents, to assess their impact on company products
Ensure that promotional package inserts and important safety information are updated as necessary
The Executive Director should have the following qualifications:
Bachelor's degree is required in Life Science or related field; Advanced degree (MS, MD, PhD, PharmD) preferred
Minimum of 15 years of industry experience; preferably some experience in GI
People management experience
Course training in ad/promo review
Strong interpersonal skills, ability to work on a team, and communication skills
Benefits:
Medical, Dental and Vision insurance
401(k) matching
Tuition reimbursement
Commuter benefits
Executive Director, Corporate Legal Counsel
San Diego, CA jobs
Executive Director, Corporate Legal Counsel page is loaded## Executive Director, Corporate Legal Counselremote type: Hybrid-San Diegolocations: San Diego, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR000519**Salary Range**The salary range for this position is: $281,000 - $351,000.*In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*
#J-18808-Ljbffr
Associate Executive Director
Marlborough, MA jobs
Primary responsibilities:
Working with department heads and assisting with interviewing, hiring, and training line staff
Staying on top of current programs, regulations, and reporting requirements for all associated agencies
Assisting and assigning duties for special functions
Acting as primary liaison between New Horizons and the business office
Maintaining appropriate records and reports in compliance with regulatory requirements, including confidentiality
Assisting with tours
Completing special projects and assuming other duties as assigned by the executive director
The preferred candidate will possess:
A professional and personable demeanor
A positive, can-do attitude
A collaborative team player mentality
Willingness to challenge the status quo, continually seeking ways to improve and lead by example
Required qualifications:
Bachelor's degree, or equivalent combination of experience and education
Superior interpersonal skills and a strong desire to enhance the quality of life of our residents
Ability to work rotating days as necessary to ensure seven-day director coverage each week
Must pass criminal background check
About New Horizons:
New Horizons at Marlborough is an upscale not-for-profit continuing care retirement community serving 450 residents on a delightful 40-acre suburban campus. Offering both independent and assisted living, New Horizons is seeking a detail-oriented Associate Executive Director for this 30-year-old senior living community in the MetroWest area.
New Horizons is owned and operated by Cummings Foundation, Inc., one of New England's three largest private foundations with net assets of more than $4 billion.
In addition to unlimited career advancement and growth potential, we offer a comprehensive compensation and benefits package that includes:
Tuition Reimbursement
Paid holiday, vacation, sick, and personal time
Cummings Properties Employee Trust (equity compensation)
Medical, dental, vision, life, and disability insurance
Competitive compensation and opportunities for bonuses
401(k) retirement savings plan with generous Company match
Charitable gift match up to $2,000 annually, plus the opportunity to direct an additional $2,000 in Company funds each year to a local nonprofit of your choice
This is an excellent opportunity for an experienced professional with exceptional management and communication skills. The schedule for this position is Tuesday through Saturday. This career opportunity offers a starting salary of $100,000.
NOTE: Candidates must be able to work on site. This is not a remote or hybrid position
Applying to New Horizons:
Interested applicants are encouraged to send a cover letter, resume, and salary history to *******************, or mail to: Cummings Foundation, Attention: Lisa VanStry, 200 West Cummings Park, Woburn, MA 01801. New Horizons is an Equal Opportunity Employer.
New Horizons prohibits smoking anywhere inside or outside of its properties at all times. In the interest of the safety and health of our employees and clients, we have a zero-tolerance policy for prohibited drug use. Please visit ************************** and ************************** to learn more about the Cummings organization.
The Commonwealth also requires CORI checks or criminal background checks for anyone who is employed either full- or part-time in any assisted living community in Massachusetts.
Associate Director Regulatory Strategy
Boston, MA jobs
Title: Associate Director of Regulatory Strategy
A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development.
Key Responsibilities
Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning.
Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters.
Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor.
Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements.
Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities.
Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation.
Qualifications
Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development.
Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies).
Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA).
Familiarity with 505(b)(2) development strategies or innovative delivery platforms.
Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas.
Proven track record of successful interactions with the FDA and/or global regulatory agencies.
Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies.
Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.
Director of Innovation
Industry, CA jobs
Founded in 1984, Best Formulations LLC, a diversified nutraceutical and personal care company headquartered in City of Industry, California, is a contract manufacturer of thousands of branded SKUs, including high quality nutritional supplements. At the core of our ethos is a dedication to personal care, where every product is crafted with meticulous attention to detail and the highest standards of quality. Our longstanding expertise in contract manufacturing dietary supplements has uniquely positioned us as leaders in research, regulatory compliance, and quality assurance.
ABOUT THE ROLE:
The Director of Customer Innovation leads all R&D and innovation initiatives that support the onboarding and development of new customer opportunities. This strategic role is responsible for recommending existing formulations, creating new product concepts, including ingredient selection, and ensuring all regulatory and product documentation is complete and compliant.
Expertise in developing and prototyping soft gels or gummies is essential. This role serves as a key liaison between commercial and innovation teams, driving efficient project execution and customer satisfaction.
The ideal candidate will have extensive experience in the nutraceutical or food industry, with a strong grasp of U.S. regulatory standards, market trends, and supplier qualification processes. Collaboration across departments is critical to ensure alignment with broader business objectives.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
New Product Development & Innovation
Lead the design and development of health supplements and nutraceutical products aligned with consumer needs and market trends.
Translate product concepts into commercially viable solutions, ensuring technical feasibility and regulatory compliance.
Partner with cross-functional teams, Regulatory, Quality, Procurement, Sales, and Marketing, to ensure smooth product development and launch.
Drive business growth through new product innovation and optimization of existing formulations.
Identify opportunities to enhance product performance, consumer appeal, and profitability.
Support technology transfer and scale-up processes in collaboration with manufacturing teams.
Conduct and optimize lab-scale experiments, ensuring accurate data collection and analysis.
Oversee pilot production and testing to validate product quality and functionality.
Recommend improvements in formulation, processes, and equipment based on experimental findings.
Develop comprehensive product specifications, including formulation details, dosage, target audience, health benefits, and supporting documentation.
QUALIFICATIONS
Strong customer-centric mindset with a passion for innovation and problem-solving.
Ability to work independently and collaboratively across global teams and departments.
Proficiency in Microsoft Office and data management systems.
Excellent communication skills, written, verbal, and interpersonal.
Master's degree in food science, Nutrition, Chemistry, or a related field.
Minimum of 10 years of product development experience, including experience in the health supplements industry.
Proven track record of successful product commercialization.
Experience in team leadership and project management.
Prior experience in a contract manufacturing environment is preferred.
Best Formulations is an equal-opportunity employer committed to employing a diverse workforce and providing medical accommodation for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet medical accommodation needs that are made known to Best Formulations in advance.
Director GHEOR
Conshohocken, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Director GHEOR
Philadelphia, PA jobs
Director of Global Health Economics and Outcomes Research
EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets.
Responsibilities:
Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management.
Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication.
Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement.
Provide strategic input into clinical trial design to inform payer and regulatory decisions.
Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs.
Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation.
Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives.
Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget.
Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives.
Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements.
Uphold the highest ethical standards in all external engagements.
Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed.
Requirements:
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship.
**Applicants who do not meet the above requirements will not be considered for this role.
Desired Skills and Experience
Graduate degree in health economics, epidemiology, health services research, or a related field
12-15+ years of HEOR/ RWE/ Outcomes Research experience
Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH)
Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies.
Deep knowledge of drug development process and payer landscape in the United States
Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams.
Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure.
Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences.
History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
Executive Director, Clinical Data Science
Remote
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Job Description Summary
We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards.
Strategic Leadership:
Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio.
Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives.
Innovation & Execution
Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine.
Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices.
Risk Management & Problem Solving
Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges.
Thought Leadership & External Engagement
Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices.
Team Leadership & Development
Manage and mentor a diverse team of data scientists and people managers across geographies.
Foster career growth through open dialogue, performance management, and strategic development planning.
Operational Excellence
Ensure GxP compliance in data science programming for clinical trials.
Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency.
Executive Communication
Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence.
Qualifications
Ph.D. in Biostatistics, Bioinformatics, or related computational sciences.
Deep expertise in statistical methods and their application in clinical trials.
Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.
Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine).
Proven experience presenting at external forums and influencing regulatory authorities.
Strong people leadership experience in a Data Science setting.
Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred.
Eisai Salary Transparency Language:
The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyExecutive Director, Toxicology
Saltaire, NY jobs
Your work will change lives. Including your own. The Impact You'll Make
As the Head of Toxicology, you will sit at the crucial intersection of Discovery and Development, supporting both our internal pipeline and strategic partnerships. You will lead a team responsible for embedding modern, data-driven decision-making into our NCE progression, ultimately accelerating our mission to decode biology to radically improve lives.
As a forward-looking leader, you will be instrumental in positioning Recursion at the forefront of the industry's shift away from reliance on traditional pre-clinical studies. You will champion the adoption and validation of highly predictive human models, as this is central to our TechBio approach of industrializing drug discovery.
In this role, you will:
Guide internal strategy and external collaborations to ensure Recursion's toxicology and safety science remains state-of-the-art, driven by the mantra to "predict more, test less."
Provide pivotal support to Discovery teams, expertly guiding them through exploratory small molecule safety studies toward Development Candidate (DC) nomination.
Support Development teams in successfully navigating regulatory (GLP / IND-enabling) small molecule studies through First-in-Human (FIH) trials and beyond.
Partner with data science, AI, and machine learning experts to design, deploy, and leverage the state-of-the-art computational and predictive tools that generate robust, clinically-relevant translational datasets within the Recursion OS.
The Team You Will Join
You will lead the Toxicology function and operate in a highly cross-functional manner, collaborating closely with leaders across Discovery, Clinical Development, Translational Biology, and our core AI/ML and Data Science organizations across our various locations.
The Experience You'll Need
Ph.D. is strongly preferred together with accreditation such as ERT or DABT.
As an experienced leader, you will have worked at / with a mixture of company types (CRO, large pharma, and biotech).
You are an integrator of information, skilled at synthesizing complex data to provide Project Teams, Partners, and Management with data-driven recommendations and risk assessments as projects advance through the portfolio.
Demonstrated ability to lead interdisciplinary, cross-functional teams in a complex organization. Must be able to manage and prioritize multiple projects to ensure they are high-quality, on time, and on budget.
Proven track record of supporting programs from preclinical discovery into clinical development, specifically supporting research for small molecule drugs.
Strong working knowledge of preclinical drug discovery models and the ability to synthesize scientific content and strategy for senior management. Must be able to manage complex variables and uncertainty to align drug development with preclinical research.
Excellent communication, presentation, and high-level negotiation skills. Ability to resolve conflict and effectively interact with diverse stakeholders, including discovery, clinical, regulatory, and operations teams.
Exceptional attention to detail, with strong planning, time management, and organizational skills.
Working Location & Compensation:
This is an office-based, hybrid position at one of our offices located in Salt Lake City, Utah / London / New York City. Employees are expected to work in the office at least 50% of the time.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $255,200 to $331,100 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyExecutive Director, Toxicology
New York, NY jobs
Your work will change lives. Including your own. The Impact You'll Make As the Head of Toxicology, you will sit at the crucial intersection of Discovery and Development, supporting both our internal pipeline and strategic partnerships. You will lead a team responsible for embedding modern, data-driven decision-making into our NCE progression, ultimately accelerating our mission to decode biology to radically improve lives.
As a forward-looking leader, you will be instrumental in positioning Recursion at the forefront of the industry's shift away from reliance on traditional pre-clinical studies. You will champion the adoption and validation of highly predictive human models, as this is central to our TechBio approach of industrializing drug discovery.
In this role, you will:
* Guide internal strategy and external collaborations to ensure Recursion's toxicology and safety science remains state-of-the-art, driven by the mantra to "predict more, test less."
* Provide pivotal support to Discovery teams, expertly guiding them through exploratory small molecule safety studies toward Development Candidate (DC) nomination.
* Support Development teams in successfully navigating regulatory (GLP / IND-enabling) small molecule studies through First-in-Human (FIH) trials and beyond.
* Partner with data science, AI, and machine learning experts to design, deploy, and leverage the state-of-the-art computational and predictive tools that generate robust, clinically-relevant translational datasets within the Recursion OS.
The Team You Will Join
You will lead the Toxicology function and operate in a highly cross-functional manner, collaborating closely with leaders across Discovery, Clinical Development, Translational Biology, and our core AI/ML and Data Science organizations across our various locations.
The Experience You'll Need
* Ph.D. is strongly preferred together with accreditation such as ERT or DABT.
* As an experienced leader, you will have worked at / with a mixture of company types (CRO, large pharma, and biotech).
* You are an integrator of information, skilled at synthesizing complex data to provide Project Teams, Partners, and Management with data-driven recommendations and risk assessments as projects advance through the portfolio.
* Demonstrated ability to lead interdisciplinary, cross-functional teams in a complex organization. Must be able to manage and prioritize multiple projects to ensure they are high-quality, on time, and on budget.
* Proven track record of supporting programs from preclinical discovery into clinical development, specifically supporting research for small molecule drugs.
* Strong working knowledge of preclinical drug discovery models and the ability to synthesize scientific content and strategy for senior management. Must be able to manage complex variables and uncertainty to align drug development with preclinical research.
* Excellent communication, presentation, and high-level negotiation skills. Ability to resolve conflict and effectively interact with diverse stakeholders, including discovery, clinical, regulatory, and operations teams.
* Exceptional attention to detail, with strong planning, time management, and organizational skills.
Working Location & Compensation:
This is an office-based, hybrid position at one of our offices located in Salt Lake City, Utah / London / New York City. Employees are expected to work in the office at least 50% of the time.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $255,200 to $331,100 (USD). You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
* We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
* We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
* We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
* We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
* We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
* We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyExecutive Director, Clinical Data Science
Hartford, CT jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Job Description Summary
We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards.
Strategic Leadership:
Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio.
Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives.
Innovation & Execution
Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine.
Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices.
Risk Management & Problem Solving
Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges.
Thought Leadership & External Engagement
Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices.
Team Leadership & Development
Manage and mentor a diverse team of data scientists and people managers across geographies.
Foster career growth through open dialogue, performance management, and strategic development planning.
Operational Excellence
Ensure GxP compliance in data science programming for clinical trials.
Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency.
Executive Communication
Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence.
Qualifications
Ph.D. in Biostatistics, Bioinformatics, or related computational sciences.
Deep expertise in statistical methods and their application in clinical trials.
Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.
Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine).
Proven experience presenting at external forums and influencing regulatory authorities.
Strong people leadership experience in a Data Science setting.
Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred.
Eisai Salary Transparency Language:
The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyExecutive Director of Clinical Development
Saltaire, NY jobs
Your work will change lives. Including your own.
The Impact You'll Make
Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. You will lead program(s) across our growing pipeline of novel small molecule therapeutics in cancer while leveraging your strong track record of advancing precision medicines in Oncology from bench to POC clinical trials with scientific rigor and a thorough understanding of target and disease biology.
In this role, you will:
Oversee the development of first-in-class/first-in-disease molecules in precision oncology
Generate and continually refine the integrated clinical development strategy for Recursion's oncology medicine portfolio from IND to POC
Contribute to regulatory submissions and participate in regulatory agency meetings
Utilize strong therapeutic area expertise to enhance innovation and efficiency in clinical trial design and execution
Deliver medical, disease-specific, and development perspective into specific research programs or broader research initiatives
Provide scientific and medical expertise for business development assessments and due diligences
The Team You'll Join
As an Executive Director of Clinical Development you will report directly to the VP of Clinical Development. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities.
The Experience You'll Need
Medical Degree required and MD/PhD preferred
5+ years of experience developing, executing and analyzing Phase 1/2 Oncology trials and preferably within a biotech or pharmaceutical company
Deep knowledge and understanding of oncology and genetic diseases; precision oncology drug development paradigms, clinical pharmacology with technical and regulatory approaches
Strong networks and connections to external experts and key opinion leaders in oncology. Ability to form effective collaborations with external scientific community, academia and CROs
Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders
Highly motivated, decisive, and results-oriented individual who is proactive, resourceful, and efficient with the flexibility and creativity to excel in and contribute to a rapidly growing drug discovery and development company
Working Location & Compensation:
This position is based at either of our offices located in Salt Lake City or New York City. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office. Relocation support can be provided for this role.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $316,800 to $413,600. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyExecutive Director of Clinical Development
New York, NY jobs
Your work will change lives. Including your own. The Impact You'll Make Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. You will lead program(s) across our growing pipeline of novel small molecule therapeutics in cancer while leveraging your strong track record of advancing precision medicines in Oncology from bench to POC clinical trials with scientific rigor and a thorough understanding of target and disease biology.
In this role, you will:
* Oversee the development of first-in-class/first-in-disease molecules in precision oncology
* Generate and continually refine the integrated clinical development strategy for Recursion's oncology medicine portfolio from IND to POC
* Contribute to regulatory submissions and participate in regulatory agency meetings
* Utilize strong therapeutic area expertise to enhance innovation and efficiency in clinical trial design and execution
* Deliver medical, disease-specific, and development perspective into specific research programs or broader research initiatives
* Provide scientific and medical expertise for business development assessments and due diligences
The Team You'll Join
As an Executive Director of Clinical Development you will report directly to the VP of Clinical Development. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities.
The Experience You'll Need
* Medical Degree required and MD/PhD preferred
* 5+ years of experience developing, executing and analyzing Phase 1/2 Oncology trials and preferably within a biotech or pharmaceutical company
* Deep knowledge and understanding of oncology and genetic diseases; precision oncology drug development paradigms, clinical pharmacology with technical and regulatory approaches
* Strong networks and connections to external experts and key opinion leaders in oncology. Ability to form effective collaborations with external scientific community, academia and CROs
* Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external stakeholders
* Highly motivated, decisive, and results-oriented individual who is proactive, resourceful, and efficient with the flexibility and creativity to excel in and contribute to a rapidly growing drug discovery and development company
Working Location & Compensation:
This position is based at either of our offices located in Salt Lake City or New York City. Please note that we are a hybrid environment and ask that employees spend 50% of their time in the office. Relocation support can be provided for this role.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $316,800 to $413,600. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
The Values We Hope You Share:
* We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
* We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
* We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
* We move with urgency because patients are waiting. Speed isn't about rushing but about moving the needle every day.
* We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy-leaders take accountability for decisive action, and teams own outcomes together.
* We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world's largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale - up to millions of wet lab experiments weekly - and massive computational scale - owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal, New York, London, Oxford area, and the San Francisco Bay area. Learn more at ****************** or connect on X (formerly Twitter) and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Auto-ApplyExecutive Director, Clinical Data Science
Washington, DC jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Job Description Summary
We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards.
Strategic Leadership:
Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio.
Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives.
Innovation & Execution
Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine.
Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices.
Risk Management & Problem Solving
Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges.
Thought Leadership & External Engagement
Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices.
Team Leadership & Development
Manage and mentor a diverse team of data scientists and people managers across geographies.
Foster career growth through open dialogue, performance management, and strategic development planning.
Operational Excellence
Ensure GxP compliance in data science programming for clinical trials.
Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency.
Executive Communication
Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence.
Qualifications
Ph.D. in Biostatistics, Bioinformatics, or related computational sciences.
Deep expertise in statistical methods and their application in clinical trials.
Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.
Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine).
Proven experience presenting at external forums and influencing regulatory authorities.
Strong people leadership experience in a Data Science setting.
Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred.
Eisai Salary Transparency Language:
The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyExecutive Director, Clinical Data Science
Miami, FL jobs
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Job Description Summary
We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards.
Strategic Leadership:
Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio.
Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives.
Innovation & Execution
Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine.
Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices.
Risk Management & Problem Solving
Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges.
Thought Leadership & External Engagement
Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices.
Team Leadership & Development
Manage and mentor a diverse team of data scientists and people managers across geographies.
Foster career growth through open dialogue, performance management, and strategic development planning.
Operational Excellence
Ensure GxP compliance in data science programming for clinical trials.
Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency.
Executive Communication
Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence.
Qualifications
Ph.D. in Biostatistics, Bioinformatics, or related computational sciences.
Deep expertise in statistical methods and their application in clinical trials.
Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics.
Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine).
Proven experience presenting at external forums and influencing regulatory authorities.
Strong people leadership experience in a Data Science setting.
Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred.
Eisai Salary Transparency Language:
The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit **********************************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyAssociate Director, Contract Operations & Administration (on-site)
Bridgewater, NJ jobs
The Associate Director of Biosimilar Contracting Operations will play a pivotal role in shaping our biosimilar and branded 505B2 (injectable) contracting operations strategy and process within Amneal. This position entails significant influence over contract management and operational decision-making that directly impacts revenue and overall business performance. The Associate Director will oversee a team dedicated to contract operations, ensuring alignment across internal departments and external partners.
The ideal candidate will have a proven track record of influencing decision-making processes and achieving revenue impact through effective customer contract operations management. The candidate will be skilled in building and maintaining collaborative relationships with internal stakeholders to ensure alignment on contracting tactics and operational execution. Strong management and communication abilities are essential, as well as expertise in cross-functional collaboration. The candidate will be responsible for articulating a clear vision and objectives, executing deliverables within timelines and adapting proactively to evolving market dynamics. The candidate's leadership will drive both team success and strategic outcomes for the organization. This position will report to the Senior Director, Biosimilar Commercial Operations and will work closely with managers and leaders across other functional areas to ensure strategic alignment with overall company and division objectives.
Essential Functions:
Contract Management - Responsible for creating a Center of Excellence for biosimilar and branded 505B2 (injectable) contract management by working to understand current processes and create evolved processes to enhance efficiencies. New and existing contracts require accurate drafting and redlining; Cross collaboration with multiple internal stakeholders; Weekly performance reviews with applicable guidance to the field/customers; Maintenance of pricing governance approvals, and renewal review cycles
Customer Account Level Operations Management - Drive the implementation of product access strategies and oversee the day-to-day customer contract operations for key accounts, and direct clients. The candidates' decisions will directly influence revenue generation and customer satisfaction.
Internal Alignment - Proactively foster collaboration with internal functional teams, including legal, compliance, finance, auditing, IT, market access, pricing, marketing and warehouse operations. Develop, refine and optimize processes and systems to ensure strategic alignment and successful execution of biosimilar contracts.
Team Leadership - Manage a dedicated US-based and offshore team, provide guidance and support to drive high performance and accountability. Empower the team to excel in customer contract operations and lead a culture of continuous process and system improvements.
Operational Success - Ensure timely review and distribution of contract requests through process implementation and team management; maintain accuracy in contract loads and collaborate with the Revenue team on price and rebate structures. Strategic oversight will be critical to achieve operational excellence.
3PL Management - Manage and enhance relationships with 3PL for product management to ensure timely customer setups and efficient product distribution. Conduct daily status calls to monitor shipping schedules, address challenges-such as inclement weather-and ensure prompt resolution. Collaborate closely with the field sales team to align on new and existing customer requests, guaranteeing that customer needs are met swiftly and effectively while maintaining optimal inventory management.
Education:
Bachelors Degree (BA/BS) relevant field (e.g. business or economics) - Required
Experience:
10 years or more in Pharmaceutical/biotech contract operations, contract administration and contract management
3 years or more in Collaborating directly with legal teams and attorneys; and field sales leaders
Skills:
Able to rapidly develop and maintain successful relationships with leaders and decision makers most likely at C-Suite level. - Advanced
Strong negotiation skills. - Advanced
Able to work well under pressure and in appreciation of pre-defined and often aggressive timelines. - Advanced
Excellent written, organizational and verbal communication skills a must. - Advanced
Computer literate with MS Office products including PowerPoint, Word, and Excel. - Advanced
Understanding or background in biosimilar pharmaceutical products. - Intermediate
Leadership skills. - Intermediate
Specialized Knowledge:
Microsoft Office - PowerPoint, Word, Outlook, Advanced Excel skills
Strong technical skills in applications such as MS Excel, MS PowerPoint, MS OneNote and other Microsoft Office suite tools
The annual salary for this position ranges from $160,000-185,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyAssociate Director, Contract Operations & Administration (on-site)
Bridgewater, NJ jobs
The Associate Director of Biosimilar Contracting Operations will play a pivotal role in shaping our biosimilar and branded 505B2 (injectable) contracting operations strategy and process within Amneal. This position entails significant influence over contract management and operational decision-making that directly impacts revenue and overall business performance. The Associate Director will oversee a team dedicated to contract operations, ensuring alignment across internal departments and external partners.
The ideal candidate will have a proven track record of influencing decision-making processes and achieving revenue impact through effective customer contract operations management. The candidate will be skilled in building and maintaining collaborative relationships with internal stakeholders to ensure alignment on contracting tactics and operational execution. Strong management and communication abilities are essential, as well as expertise in cross-functional collaboration. The candidate will be responsible for articulating a clear vision and objectives, executing deliverables within timelines and adapting proactively to evolving market dynamics. The candidate's leadership will drive both team success and strategic outcomes for the organization. This position will report to the Senior Director, Biosimilar Commercial Operations and will work closely with managers and leaders across other functional areas to ensure strategic alignment with overall company and division objectives.
Essential Functions:
* Contract Management - Responsible for creating a Center of Excellence for biosimilar and branded 505B2 (injectable) contract management by working to understand current processes and create evolved processes to enhance efficiencies. New and existing contracts require accurate drafting and redlining; Cross collaboration with multiple internal stakeholders; Weekly performance reviews with applicable guidance to the field/customers; Maintenance of pricing governance approvals, and renewal review cycles
* Customer Account Level Operations Management - Drive the implementation of product access strategies and oversee the day-to-day customer contract operations for key accounts, and direct clients. The candidates' decisions will directly influence revenue generation and customer satisfaction.
* Internal Alignment - Proactively foster collaboration with internal functional teams, including legal, compliance, finance, auditing, IT, market access, pricing, marketing and warehouse operations. Develop, refine and optimize processes and systems to ensure strategic alignment and successful execution of biosimilar contracts.
* Team Leadership - Manage a dedicated US-based and offshore team, provide guidance and support to drive high performance and accountability. Empower the team to excel in customer contract operations and lead a culture of continuous process and system improvements.
* Operational Success - Ensure timely review and distribution of contract requests through process implementation and team management; maintain accuracy in contract loads and collaborate with the Revenue team on price and rebate structures. Strategic oversight will be critical to achieve operational excellence.
* 3PL Management - Manage and enhance relationships with 3PL for product management to ensure timely customer setups and efficient product distribution. Conduct daily status calls to monitor shipping schedules, address challenges-such as inclement weather-and ensure prompt resolution. Collaborate closely with the field sales team to align on new and existing customer requests, guaranteeing that customer needs are met swiftly and effectively while maintaining optimal inventory management.
Auto-ApplyAssociate Director, Contract Operations & Administration (on-site)
Bradley Gardens, NJ jobs
The Associate Director of Biosimilar Contracting Operations will play a pivotal role in shaping our biosimilar and branded 505B2 (injectable) contracting operations strategy and process within Amneal. This position entails significant influence over contract management and operational decision-making that directly impacts revenue and overall business performance. The Associate Director will oversee a team dedicated to contract operations, ensuring alignment across internal departments and external partners.
The ideal candidate will have a proven track record of influencing decision-making processes and achieving revenue impact through effective customer contract operations management. The candidate will be skilled in building and maintaining collaborative relationships with internal stakeholders to ensure alignment on contracting tactics and operational execution. Strong management and communication abilities are essential, as well as expertise in cross-functional collaboration. The candidate will be responsible for articulating a clear vision and objectives, executing deliverables within timelines and adapting proactively to evolving market dynamics. The candidate's leadership will drive both team success and strategic outcomes for the organization. This position will report to the Senior Director, Biosimilar Commercial Operations and will work closely with managers and leaders across other functional areas to ensure strategic alignment with overall company and division objectives.
Essential Functions:
Contract Management - Responsible for creating a Center of Excellence for biosimilar and branded 505B2 (injectable) contract management by working to understand current processes and create evolved processes to enhance efficiencies. New and existing contracts require accurate drafting and redlining; Cross collaboration with multiple internal stakeholders; Weekly performance reviews with applicable guidance to the field/customers; Maintenance of pricing governance approvals, and renewal review cycles
Customer Account Level Operations Management - Drive the implementation of product access strategies and oversee the day-to-day customer contract operations for key accounts, and direct clients. The candidates' decisions will directly influence revenue generation and customer satisfaction.
Internal Alignment - Proactively foster collaboration with internal functional teams, including legal, compliance, finance, auditing, IT, market access, pricing, marketing and warehouse operations. Develop, refine and optimize processes and systems to ensure strategic alignment and successful execution of biosimilar contracts.
Team Leadership - Manage a dedicated US-based and offshore team, provide guidance and support to drive high performance and accountability. Empower the team to excel in customer contract operations and lead a culture of continuous process and system improvements.
Operational Success - Ensure timely review and distribution of contract requests through process implementation and team management; maintain accuracy in contract loads and collaborate with the Revenue team on price and rebate structures. Strategic oversight will be critical to achieve operational excellence.
3PL Management - Manage and enhance relationships with 3PL for product management to ensure timely customer setups and efficient product distribution. Conduct daily status calls to monitor shipping schedules, address challenges-such as inclement weather-and ensure prompt resolution. Collaborate closely with the field sales team to align on new and existing customer requests, guaranteeing that customer needs are met swiftly and effectively while maintaining optimal inventory management.
Qualifications
Education:
Bachelors Degree (BA/BS) relevant field (e.g. business or economics) - Required
Experience:
10 years or more in Pharmaceutical/biotech contract operations, contract administration and contract management
3 years or more in Collaborating directly with legal teams and attorneys; and field sales leaders
Skills:
Able to rapidly develop and maintain successful relationships with leaders and decision makers most likely at C-Suite level. - Advanced
Strong negotiation skills. - Advanced
Able to work well under pressure and in appreciation of pre-defined and often aggressive timelines. - Advanced
Excellent written, organizational and verbal communication skills a must. - Advanced
Computer literate with MS Office products including PowerPoint, Word, and Excel. - Advanced
Understanding or background in biosimilar pharmaceutical products. - Intermediate
Leadership skills. - Intermediate
Specialized Knowledge:
Microsoft Office - PowerPoint, Word, Outlook, Advanced Excel skills
Strong technical skills in applications such as MS Excel, MS PowerPoint, MS OneNote and other Microsoft Office suite tools
The annual salary for this position ranges from $160,000-185,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyExec. Director, Marketing - Solid Tumors
Chadds Ford, PA jobs
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function): This individual leads the product strategy for significant product(s) in Incyte's solid tumor portfolio.
The position is responsible for building out the product strategy for key brands in the portfolio and and key processes to drive maximum market potential.
This individual leads the product strategy team that works collaboratively with key stakeholders including Sales, Market Access, Medical Affairs, Market Insights, Regulatory, Development, Legal and Finance to effectively execute on commercial strategies and for in line brands and future pipeline products.
This role requires a minimum of 3 days in the office and allows for up to 2 days remote.
Essential Functions of the Job (Key responsibilities): • Provide commercial support through: o Development of in line product strategies to maximize growth and potential .
o Provide market landscape/competitive assessments to support market opportunities.
o Lead the execution of brand strategies to drive commercial potential.
o Development of target product profiles.
o Market/opportunity forecasting.
• Liaise with global partners on lifecycle/product plans.
• Develop and maintain a high degree of therapeutic area knowledge.
• Develop relationships with key external thought leaders in areas of interest.
• Perform all company business in accordance with regulations and company policies and procedures.
• Provide leadership and guidance to the product strategy team.
Qualifications (Minimal acceptable level of education, work experience, and competency): • Bachelor's degree required.
Advanced science, medical or business degree strongly preferred.
• 15+ year's commercial operating experience including brand leadership and launches.
• Experience working in both global and regional roles; international experience preferred.
• Extensive oncology and/or hematology leadership experience.
• Experience working on external collaborations.
• Proven ability to work with cross-functional teams and to interact with senior leadership.
• Significant familiarity with drug development process.
• Superior communication skills and the ability to synthesize and communicate complex information.
• Ability to work independently in a rapidly changing environment.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You can learn more about this process here.
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You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
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