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Agency Director jobs at Sanofi US

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  • Director, BD&L Forecasting

    CSL Behring 4.6company rating

    King of Prussia, PA jobs

    The Opportunity: Reporting to the Senior Director of Global Forecasting & Portfolio Analytics, you will lead the BD&L forecasting and Analytics for Cardiovascular and Renal (CVR) and Transplant and Immunology (T&I) therapy areas In this role, you will drive decision-making across all BD&L due diligence efforts via commercial revenue forecasting for both pre- and full-fledged due diligence workstreams and represent Insights & Analytics (I&A) forecasting within the commercial due diligence team You will be expected to follow all CSL I&A forecasting standards, ensuring accuracy and alignment with business stakeholders You will be the primary point of contact representing I&A forecasting for maximization and special projects across the CSL portfolio This role would require strong consultancy orientation and the ability to communicate effectively and efficiently with all organizational stakeholders. As a part of the Global I&A team, you will play a pivotal role in shaping our strategic direction and optimizing our pharmaceutical portfolio. The Role: Lead end to end forecasting & analytics efforts for all business development workstreams at CSL for CVR and T&I Would include conducting high level assessments for early research stage assets as well as deep dive commercial assessments and valuations for late-stage opportunities or a mix of both Would need prior experience with conducting and validating market research and competitive landscape analysis along with thoughtful incorporation into BD&L forecasts Would need the ability to plan, execute and deliver multiple time sensitive projects with both accuracy and speed under tight timelines Leverage internal forecasting standards and triangulate inputs from R&D, Commercial Development, Market Research, Competitive Intelligence, Pricing & Access, Legal/IP to create robust and defendable forecasts/scenarios Represent Forecasting and Portfolio Analytics function within commercial due diligence team, providing critical insights and analysis to support strategic decisions. Collaborate with cross-functional teams to integrate data-driven insights into strategic planning, commercial strategies, and decision-making processes. Oversee the analysis of market trends, competitor landscapes, and emerging technologies to identify opportunities and risks for business growth. Provide leadership in the evaluation of potential partnerships, licensing agreements, and M&A opportunities by delivering data-driven insights. Stay updated on industry trends, regulatory changes, and advancements in forecasting and analytics methodologies within the biotech and pharmaceutical sectors. Support to ensure strategic fit of opportunities coherent with CSL TA strategy Drive continuous improvement in BD&L forecasting capabilities within the Forecasting COE, including identification of talent gaps and develop training programs to enhance team capabilities Qualifications: Minimum of a bachelor's degree with preferred focus in a scientific or business field (finance, analytics, economics, analytics/statistics or related). Post-graduate qualifications preferred 10+ years' experience in the pharmaceutical/biotechnology industry working across multiple therapeutic areas 6+ years of experience running/leading forecasting teams in biotech/pharma industry Hands on expertise with all forecasting techniques including time series modeling and statistical trending algorithms, patient-based/TRx modeling Experienced in multiple forecasting & BI tools including but not limited to Forecast Pro, @Risk or other monte-carlo simulation tools, Tableau, QlikSense etc. Experience with conducting detailed literature reviews for Epidemiology as well as expertise & thoughtful utilization of available datasets such as Oracle DB/Legacy Kantar, Datamonitor, Evaluate, Globaldata, IQVIA, Symphony, ADIVO, GERS, UNOS etc. Experience working with Rx, patient claims, pricing (WAC) and managed markets data sources (e.g. IQVIA, SHS, MMIT, Komodo, Clarivate, IPD Analytics) Strong interpersonal skills to quickly build rapport and credibility with organization leaders and key external stakeholders Extensive experience leading planning cycles in commercial, forecasting, or analytical roles This is a hybrid position out of our King of Prussia offices. You must be in the office 3 days a week and one of the days must include a Monday or Friday. Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!
    $56k-110k yearly est. 4d ago
  • Executive Director of Regulatory Ad/Promo

    EPM Scientific 3.9company rating

    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
    $104k-180k yearly est. 2d ago
  • Executive Director, Corporate Legal Counsel

    Crinetics Pharmaceuticals, Inc. 3.9company rating

    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
    $101k-168k yearly est. 1d ago
  • Director GHEOR

    EPM Scientific 3.9company rating

    Conshohocken, PA jobs

    Director of Global Health Economics and Outcomes Research EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets. Responsibilities: Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management. Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication. Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement. Provide strategic input into clinical trial design to inform payer and regulatory decisions. Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs. Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation. Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives. Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget. Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives. Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements. Uphold the highest ethical standards in all external engagements. Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed. Requirements: Graduate degree in health economics, epidemiology, health services research, or a related field 12-15+ years of HEOR/ RWE/ Outcomes Research experience Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH) Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies. Deep knowledge of drug development process and payer landscape in the United States Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams. Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure. Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences. History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments. Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship. **Applicants who do not meet the above requirements will not be considered for this role. Desired Skills and Experience Graduate degree in health economics, epidemiology, health services research, or a related field 12-15+ years of HEOR/ RWE/ Outcomes Research experience Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH) Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies. Deep knowledge of drug development process and payer landscape in the United States Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams. Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure. Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences. History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
    $55k-110k yearly est. 4d ago
  • Director GHEOR

    EPM Scientific 3.9company rating

    Philadelphia, PA jobs

    Director of Global Health Economics and Outcomes Research EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire a Director of GHEOR. Our client is seeking a health economics & outcomes research expert to drive evidence generation strategy and align with Global Medical Affairs and business objectives to optimize patient access, pricing, and reimbursement across US and international markets. Responsibilities: Integrate input from U.S., European, and other global teams into a comprehensive evidence plan supporting market access and lifecycle management. Design and execute HEOR studies, including network meta-analyses and real-world evidence projects, from concept through publication. Develop HTA and launch deliverables such as value dossiers, systematic literature reviews, economic models, and innovative tools for payer engagement and reimbursement. Provide strategic input into clinical trial design to inform payer and regulatory decisions. Ensure compliant dissemination of HEOR materials per regulatory guidance and internal SOPs. Build strategic partnerships with external experts, policymakers, payers, and academic institutions to support asset strategies and evidence generation. Manage GHEOR budget planning, forecasting, and resource allocation for U.S. and international initiatives. Oversee external vendor contracts and timelines to ensure deliverables are on time, within scope, and within budget. Mentor and train team members, fostering continuous development and aligning publication activities with strategic objectives. Ensure all activities adhere to company SOPs, industry standards, and regulatory requirements. Uphold the highest ethical standards in all external engagements. Willingness to travel up to 30%, primarily U.S. with occasional international travel; ability to work across time zones as needed. Requirements: Graduate degree in health economics, epidemiology, health services research, or a related field 12-15+ years of HEOR/ RWE/ Outcomes Research experience Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH) Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies. Deep knowledge of drug development process and payer landscape in the United States Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams. Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure. Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences. History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments. Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship. **Applicants who do not meet the above requirements will not be considered for this role. Desired Skills and Experience Graduate degree in health economics, epidemiology, health services research, or a related field 12-15+ years of HEOR/ RWE/ Outcomes Research experience Deep knowledge of international regulatory and value assessment bodies (e.g., ICER) and HTA agencies (e.g., NICE, CADTH) Expertise in economic modeling, patient-reported outcomes (PROs), statistics, and real-world evidence studies. Must have experience executing complex observational studies. Deep knowledge of drug development process and payer landscape in the United States Strong interpersonal and influencing abilities to collaborate effectively with internal and external stakeholders across cross-functional, matrixed teams. Highly organized with expertise in project management, including budgeting, contracting, vendor oversight, and managing multiple priorities under pressure. Outstanding written and verbal communication skills, with experience creating technical and value-focused materials for diverse audiences. History demonstrating a proactive approach to problem-solving and adaptability in dynamic/ fast-paced environments.
    $55k-110k yearly est. 4d ago
  • Executive Director, Clinical Data Science

    Eisai 4.8company rating

    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
    $283.2k-371.7k yearly Auto-Apply 14d ago
  • Deputy Director, Meetings Strategy

    American Society of Hematology 4.7company rating

    Washington, DC jobs

    Join the Leader in Hematology: Shape the Future of Global Scientific Meetings Salary Range: $155,000 - $210,000 (commensurate with experience and proven impact) The American Society of Hematology (ASH) is the world's largest professional society of hematologists, dedicated to advancing the understanding, diagnosis, treatment, and prevention of blood disorders. Since its founding in 1958, ASH has played a vital role in shaping hematology as a discipline and continues to lead with impact through groundbreaking research, education, and convenings. For more than six decades, ASH's Annual Meeting has served as the premier scientific and educational event in the field-bringing together more than 30,000 professionals from around the globe. ASH is seeking a dynamic and strategic leader to serve as Deputy Director or Director, Meetings Strategy (title commensurate with experience and proven impact). This pivotal role partners closely with the Chief Event Strategy Officer to lead the vision, planning, and execution of ASH's high-profile meetings portfolio. Monitoring multi-million-dollar budgets, this leader is responsible for driving operational excellence, innovative business strategies, and data-informed decisions that enhance the impact and reach of ASH-hosted events. Key responsibilities include guiding internal teams and external partners, cultivating high-value vendor and venue relationships, and leading major contract negotiations to ensure long-term value and financial sustainability. This is an extraordinary opportunity to help shape the future of one of the world's most respected scientific convenings and contribute meaningfully to ASH's global mission. ASH has a collegial, high-energy, and results-driven work environment with a strong commitment to inclusive excellence. Our staff take pride in effective time and resource management. We highly value collaboration, education, innovation, and excellence. We are looking for candidates who have demonstrated these values in their day-to-day work experience. Your cover letter (required) and resume should address the qualifications outlined below. QUALIFICATIONS, KNOWLEDGE AND SKILL REQUIRED: (Minimum education and experience needed to perform the job adequately) Bachelor's degree required; advanced degree in business, hospitality, event management, or related field preferred. Minimum of 7 years of progressively responsible experience in planning and executing large-scale, high-profile national or international meetings and conferences. Prior leadership experience in a professional association, scientific society, or healthcare-related organization strongly preferred. Proven track record of leading complex meeting portfolios , including strategic planning, logistics, budgeting, vendor management, and performance measurement. Experience developing and managing multi-million-dollar budgets and using financial acumen to drive return on investment. Demonstrated ability to translate organizational goals into effective event strategies that enhance engagement, visibility, and mission impact. Strong experience in managing, mentoring, and developing staff and cross-functional teams. Ability to lead with a collaborative, inclusive, and high-performance mindset , especially within matrixed organizations. Skilled at managing external consultants and vendors , ensuring alignment with organizational standards and goals. Exceptional interpersonal skills with the ability to build and sustain relationships with venues, strategic partners, sponsors, and internal stakeholders. Deep experience in contract negotiation and risk mitigation , with a focus on delivering financial and operational value to the organization. Experience using event technology platforms and project management tools to drive efficiency and scale. Track record of applying innovation and data insights to enhance event experiences, expand reach, and anticipate audience needs. Strong executive presence and communication skills , including the ability to influence at senior levels. Comfortable working in a fast-paced, high-stakes environment with multiple priorities and stakeholders. Demonstrated commitment to creating and supporting inclus ive environments in event design and team leadership. Ability to work under pressure, to keep confidential information, and conduct oneself in a professional manner at all times. Flexibility with schedule and willingness to work extended hours during the heavy conference season in order to meet deadlines. ASH has a hybrid work environment whereby eligible positions may work remotely on Mondays and Fridays, and all staff report to the office Tuesday through Thursday each week. ASH is committed to your professional growth and development and provides meaningful and rewarding career experience. The ASH office is within walking distance of several Metro stations on the Blue/Orange/Silver and Red lines. Hit apply and submit a required cover letter and resume. No candidate will be considered who does not provide a cover letter. Speak to how you would demonstrate alignment with the ASH Mission. Current ASH Job Openings The American Society for Hematology (ASH) is an equal opportunity employer that is committed to an inclusive work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, veteran status, or any other protected characteristic as outlined by applicable federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, leave of absence, compensation, benefits, and training. ASH makes hiring decisions based solely on qualifications, merit, and business needs at the time.
    $155k-210k yearly Auto-Apply 60d+ ago
  • Deputy Director, Meetings Strategy

    American Society of Hematology 4.7company rating

    Washington, DC jobs

    Join the Leader in Hematology: Shape the Future of Global Scientific Meetings Salary Range: $155,000 - $210,000 ( commensurate with experience and proven impact ) The American Society of Hematology (ASH) is the world's largest professional society of hematologists, dedicated to advancing the understanding, diagnosis, treatment, and prevention of blood disorders. Since its founding in 1958, ASH has played a vital role in shaping hematology as a discipline and continues to lead with impact through groundbreaking research, education, and convenings. For more than six decades, ASH's Annual Meeting has served as the premier scientific and educational event in the field-bringing together more than 30,000 professionals from around the globe. ASH is seeking a dynamic and strategic leader to serve as Deputy Director or Director, Meetings Strategy (title commensurate with experience and proven impact). This pivotal role partners closely with the Chief Event Strategy Officer to lead the vision, planning, and execution of ASH's high-profile meetings portfolio. Monitoring multi-million-dollar budgets, this leader is responsible for driving operational excellence, innovative business strategies, and data-informed decisions that enhance the impact and reach of ASH-hosted events. Key responsibilities include guiding internal teams and external partners, cultivating high-value vendor and venue relationships, and leading major contract negotiations to ensure long-term value and financial sustainability. This is an extraordinary opportunity to help shape the future of one of the world's most respected scientific convenings and contribute meaningfully to ASH's global mission. ASH has a collegial, high-energy, and results-driven work environment with a strong commitment to inclusive excellence. Our staff take pride in effective time and resource management. We highly value collaboration, education, innovation, and excellence. We are looking for candidates who have demonstrated these values in their day-to-day work experience. Your cover letter (required) and resume should address the qualifications outlined below. QUALIFICATIONS, KNOWLEDGE AND SKILL REQUIRED: (Minimum education and experience needed to perform the job adequately) Bachelor's degree required; advanced degree in business, hospitality, event management, or related field preferred. Minimum of 7 years of progressively responsible experience in planning and executing large-scale, high-profile national or international meetings and conferences. Prior leadership experience in a professional association, scientific society, or healthcare-related organization strongly preferred. Proven track record of leading complex meeting portfolios, including strategic planning, logistics, budgeting, vendor management, and performance measurement. Experience developing and managing multi-million-dollar budgets and using financial acumen to drive return on investment. Demonstrated ability to translate organizational goals into effective event strategies that enhance engagement, visibility, and mission impact. Strong experience in managing, mentoring, and developing staff and cross-functional teams. Ability to lead with a collaborative, inclusive, and high-performance mindset, especially within matrixed organizations. Skilled at managing external consultants and vendors, ensuring alignment with organizational standards and goals. Exceptional interpersonal skills with the ability to build and sustain relationships with venues, strategic partners, sponsors, and internal stakeholders. Deep experience in contract negotiation and risk mitigation, with a focus on delivering financial and operational value to the organization. Experience using event technology platforms and project management tools to drive efficiency and scale. Track record of applying innovation and data insights to enhance event experiences, expand reach, and anticipate audience needs. Strong executive presence and communication skills, including the ability to influence at senior levels. Comfortable working in a fast-paced, high-stakes environment with multiple priorities and stakeholders. Demonstrated commitment to creating and supporting inclusive environments in event design and team leadership. Ability to work under pressure, to keep confidential information, and conduct oneself in a professional manner at all times. Flexibility with schedule and willingness to work extended hours during the heavy conference season in order to meet deadlines. ASH has a hybrid work environment whereby eligible positions may work remotely on Mondays and Fridays, and all staff report to the office Tuesday through Thursday each week. ASH is committed to your professional growth and development and provides meaningful and rewarding career experience. The ASH office is within walking distance of several Metro stations on the Blue/Orange/Silver and Red lines. Hit apply and submit a required cover letter and resume. No candidate will be considered who does not provide a cover letter. Speak to how you would demonstrate alignment with the ASH Mission. Current ASH Job Openings The American Society for Hematology (ASH) is an equal opportunity employer that is committed to an inclusive work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, veteran status, or any other protected characteristic as outlined by applicable federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, leave of absence, compensation, benefits, and training. ASH makes hiring decisions based solely on qualifications, merit, and business needs at the time.
    $155k-210k yearly Auto-Apply 60d+ ago
  • Director, Translational Pathology

    Daiichi Sankyo 4.8company rating

    Ridgefield, NJ jobs

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Director, Translational Pathology will work across the Translational Science matrix to develop and implement pathology-based translational approaches to assessing PD and patient selection biomarkers for Oncology and Specialty Medicine programs. They will further serve as the scientific expert supporting digital pathology investigations and as a point of contact for developing and managing external partnerships in support of translational science and CDx programs. They will provide the expertise to create and integrate pathology datasets with broader multi-omic analyses to support hypothesis-driven translational research efforts with direct impact across the Development continuum. They will work in a highly collaborative environment. Responsibilities: - Design and build internal digital pathology capabilities and support data generation for translational pathology evaluations across the portfolio. Develop and manage partnerships, largely focused on digital pathology, to support design and implementation of translational pathology plans. - Lead development of the translational pathology strategic direction and support data generation for assigned assets, with a focus on the design and implementation of translational pathology plans. - Provide expertise to the Daiichi Sankyo Global Research Development organization to ensure access to state-of-the-art thinking on appropriate translational pathology strategies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to proposed business plans. - Communicate with portfolio leaders in Clinical Development, Discovery, QCP, CDx, RA, MA or other relevant functions to ensure effective integration of translational pathology strategy into broader Translational/Program strategies Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - MD or MD PhD with Anatomic Pathology board certification required. Experience Qualifications: - 5 or more years of post-doctoral and relevant industry experience with expertise in pathology-driven translational research, biomedical leadership and human translational research in clinical trials required - Experience with digital/computational pathology technologies and translational research required - Extensive experience in the discovery, characterization and utilization of innovative translational strategies across the continuum of preclinical and clinical stages preferred. - Experience/knowledge in companion diagnostics device development preferred - Demonstrated ability to define clear translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development required - Deep knowledge in pathology-based and other biomarker technologies including immunohistochemistry (monoplex and multiplex), digital pathology, spatial analyses, NGS, immunoassay, proteomics including expertise in assay validation required Travel: Ability to travel up to 10%. Global travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $215,360.00 - $323,040.00 Download Our Benefits Summary PDF
    $215.4k-323k yearly Auto-Apply 60d+ ago
  • Director, Translational Pathology

    Daiichi Sankyo 4.8company rating

    Ridgefield, NJ jobs

    Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Director, Translational Pathology will work across the Translational Science matrix to develop and implement pathology-based translational approaches to assessing PD and patient selection biomarkers for Oncology and Specialty Medicine programs. They will further serve as the scientific expert supporting digital pathology investigations and as a point of contact for developing and managing external partnerships in support of translational science and CDx programs. They will provide the expertise to create and integrate pathology datasets with broader multi-omic analyses to support hypothesis-driven translational research efforts with direct impact across the Development continuum. They will work in a highly collaborative environment. Responsibilities: * Design and build internal digital pathology capabilities and support data generation for translational pathology evaluations across the portfolio. Develop and manage partnerships, largely focused on digital pathology, to support design and implementation of translational pathology plans. * Lead development of the translational pathology strategic direction and support data generation for assigned assets, with a focus on the design and implementation of translational pathology plans. * Provide expertise to the Daiichi Sankyo Global Research Development organization to ensure access to state-of-the-art thinking on appropriate translational pathology strategies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to proposed business plans. * Communicate with portfolio leaders in Clinical Development, Discovery, QCP, CDx, RA, MA or other relevant functions to ensure effective integration of translational pathology strategy into broader Translational/Program strategies Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) * MD or MD PhD with Anatomic Pathology board certification required. Experience Qualifications: * 5 or more years of post-doctoral and relevant industry experience with expertise in pathology-driven translational research, biomedical leadership and human translational research in clinical trials required * Experience with digital/computational pathology technologies and translational research required * Extensive experience in the discovery, characterization and utilization of innovative translational strategies across the continuum of preclinical and clinical stages preferred. * Experience/knowledge in companion diagnostics device development preferred * Demonstrated ability to define clear translational strategies anchored in disease biology and drug mechanism of action, aligned with clinical development required * Deep knowledge in pathology-based and other biomarker technologies including immunohistochemistry (monoplex and multiplex), digital pathology, spatial analyses, NGS, immunoassay, proteomics including expertise in assay validation required Travel: Ability to travel up to 10%. Global travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $215,360.00 - $323,040.00 Download Our Benefits Summary PDF
    $215.4k-323k yearly 22d ago
  • Executive Director, Toxicology

    Recursion 4.2company rating

    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.
    $255.2k-331.1k yearly Auto-Apply 60d ago
  • Executive Director, Toxicology

    Recursion Pharmaceuticals 4.2company rating

    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.
    $255.2k-331.1k yearly Auto-Apply 60d+ ago
  • Assoc Dir, Regulatory Strategist, Safety & Toxicology

    PDI 4.4company rating

    Woodcliff Lake, NJ jobs

    Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The Associate Director, Regulatory Affairs Strategy - Safety and Toxicology will develop and execute product safety strategies that drive business innovation while ensuring regulatory compliance. This role will provide leadership and guidance for regulatory submissions, health authority interactions, new product development, and existing product maintenance as well as overseeing raw material and formula clearance for product safety and compliance. The ideal candidate will combine strong regulatory knowledge with hands-on experience to ensure product safety over the full life cycle of a diverse portfolio of healthcare and consumer regulated products including but not limited to drugs, devices, cosmetics, surface sanitizers and disinfects. ESSENTIAL FUNCTIONS AND BASIC DUTIES Contributions * Lead Product Safety and Toxicology team in developing and executing safety strategies for new product development and maintenance of existing products to ensure successful commercialization across product life cycle * Develop and execute non-clinical safety strategies to generate pre-clinical data for new product development marketing authorization applications * Investigational/New Drug Applications (IND/NDA) * Medical Devices Pre-Market Notifications (510(k)) * Pesticides - FIFRA §3 * Develop and execute non-clinical safety strategies for qualifying impurities and new inactive ingredients * Assess non-clinical safety data and advise project teams on potential in-vitro and in-vivo clinical and non-clinical safety study requirements * Design, coordinate and monitor in-vitro and in-vivo clinical and non-clinical safety studies * Ensure studies comply with Good Laboratory Practice (GLP) standards and FDA and HC recognized regulatory guidelines * Author and review non-clinical sections of regulatory submission documents (IND/NDA/510(k)/FIFRA §3) * Prepare, oversee, and deliver raw material and formulation toxicological risk assessments, safety clearances, and Consumer Products Safety Reviews (CPSR) * Prepare, oversee, and deliver Safety Data Sheets (SDS) for drugs, devices, disinfectants, cosmetics and cleaning products * Represent Product Safety in cross-functional new product development (NPD) teams * Represent PDI at industry meetings related to safety (SOT, PCPC, HCPA) * Monitor trends, emerging regulations, guidance, and best practices (regulatory intelligence) related to safety compliance and product development * Communicate and collaborate in acting on regulatory intelligence that has potential to impact the business * Ensure products meet all the necessary Federal and State safety regulations and reporting requirements for U.S. and CA Oversee 1 direct report to: * Review, approve, and certify all formulation raw ingredients, nonwovens, packaging, and fragrances for intended use, country of launch (U.S./CA), and compliance with latest regulations and customer requirements * Generate Safety Data Sheets (SDS) by reviewing formulations and developing safety, precautionary, and first aid language * Ensure supplier compliance by updating Raw Material Information Review (RMIR), nonwoven, packaging, and fragrance requirements according to the latest regulatory and customer requirements * Obtain third party seals of approval from EPA Safer Choice, EPA Design for Environment (DfE), National Eczema association (NEA), United States Department of Agriculture Biobased (USDA), and Environmental Working Group (EWG) * Provide support for safety related claims e.g. Non-Animal Tested Declaration, Food Allergen Declaration, "Free from" Declaration * Provide support for compliance requirements (e.g. Modernization of Cosmetics Regulation Act of 2022 (MoCRA) Safety Substantiation, IFRA 52nd Amendment (2026), Hazard Communication Standard (SDS) Updates; California CFFIRKA allergen reporting requirements) Cross-Functional Support * Collaboration: Work closely with multidisciplinary teams, including R&D, Clinical, Manufacturing, and Quality functions to integrate safety findings/plans into the overall drug development strategy, align regulatory submissions with development and operational plans, and ensure project timelines are met. * Problem Solving: Generate hypotheses and investigative strategies to address any safety concerns or unexpected findings that arise during the non-clinical phase. * Participate: in health authority interactions (FDA, Health Canada) by contributing to meeting materials and supporting response strategies. Operational Excellence * Maintain and strengthen safety documentation, templates, and SOPs to support consistent, high-quality safety assessments and strategies. * Partner with cross-functional colleagues to identify process improvements and leverage tools that enhance efficiency and accuracy in development and maintenance projects. Mentorship and Collaboration * Provide guidance and support to junior regulatory staff where applicable, sharing expertise and best practices. * Foster collaborative relationships internally and with external partners/sponsors. PERFORMANCE MEASUREMENTS * Achievement: consistent delivery of complete, accurate and on-time high-quality technical work with minimal issues * Ownership: Independent and proactive management of assigned projects to ensure complete, accurate and timely completion * Collaboration: Effective teamwork and communication across functions to achieve shared objectives * Innovation: Introduction of creative solutions and contributions to process improvements and new product ideas QUALIFICATIONS EDUCATION/CERTIFICATION * Bachelor's degree in life sciences, pharmacy, or related field required; advanced degree (PharmD, PhD, MS) and/or CCCTO or DABT certifications a plus REQUIRED KNOWLEDGE * Solid knowledge of FDA safety regulations; experience with ex-US authorities (Health Canada) desirable * Demonstrated ability to contribute to safety strategies and regulatory submissions across multiple phases of development EXPERIENCE REQUIRED * 8-10 years of safety experience in pharmaceuticals, biotech, medical devices, or pesticides including submission experience in IND/NDA, 510(k), FIFRA §3 or equivalent SKILLS/ABILITIES * Strong organizational skills with attention to detail, quality, and timelines * Excellent written and verbal communication skills; ability to work in cross-functional teams * Excellent organizational, prioritization abilities, tracking and follow-up skills * Ability to complete projects on time and handle multiple parallel projects in a fast-paced environment * Good analytical and problem-solving abilities, communication and interpersonal, and record keeping skills * Strong attention to detail * Ability to handle multiple tasks / projects simultaneously and bring them to completion on time * Self-starter with ability to think and act independently and to make sound decisions * Fast learner with a flexible style and the ability to adjust to changing business priorities * Ability to interface with internal and external contacts at all levels * Great flexibility and ability to work well with shifting priorities WORKING CONDITIONS Environment: Corporate office with on-site R&D laboratories Work Schedule: Hybrid (4-days/week onsite, 1-day/week remote) SALARY RANGE: * $150,000 - $180,000 annually BENEFITS PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes: * Medical, behavioral & prescription drug coverage * Health Savings Account (HSA) * Dental * Vision * 401(k) savings plan with company match and profit sharing * Basic and supplemental Life and AD&D insurance * Flexible Spending Accounts (FSAs) * Short & long-term disability * Employee Assistance Program (EAP) * Health Advocacy Program PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts. At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
    $150k-180k yearly 19d ago
  • Executive Director of Clinical Development

    Recursion 4.2company rating

    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.
    $124k-214k yearly est. Auto-Apply 52d ago
  • Executive Director of Clinical Development

    Recursion Pharmaceuticals 4.2company rating

    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.
    $123k-212k yearly est. Auto-Apply 54d ago
  • Executive Director, Clinical Data Science

    Eisai 4.8company rating

    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
    $104k-189k yearly est. Auto-Apply 14d ago
  • Executive Director, Clinical Data Science

    Eisai 4.8company rating

    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
    $100k-179k yearly est. Auto-Apply 14d ago
  • Executive Director, Clinical Data Science

    Eisai 4.8company rating

    Tampa, 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
    $100k-178k yearly est. Auto-Apply 14d ago
  • Executive Director, Clinical Data Science

    Eisai 4.8company rating

    Atlanta, GA 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
    $96k-173k yearly est. Auto-Apply 14d ago
  • Executive Director, Clinical Data Science

    Eisai 4.8company rating

    Jacksonville, 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
    $95k-170k yearly est. Auto-Apply 14d ago

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