Associate Director jobs at Charles River Labs

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional collaboration. Key Responsibilities Lead the Biostatistics function for the assigned Cardio and Renal Therapeutic Area (TA), with accountability for statistical deliverables across all stages of clinical development. Provide statistical thought leadership to Clinical Development teams in the design of clinical development plans, and clinical trials, ensuring robust methodology and alignment with program objectives. Partner with Therapeutic Area (TA) leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans (CDPs), target product profiles (TPPs), and regulatory submissions. Ensure high-quality statistical input into study protocols, analysis plans, clinical study reports, and regulatory documentation. Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA) and contribute to preparation of statistical content in submission dossiers. Champions the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks (e.g., Go/No-Go criteria, assurance). Collaborate with other functions (e.g., Epidemiology, Safety) on initiatives such as real-world evidence and patient safety analysis. Manage, develop, and mentor statisticians within the therapeutic area to build technical capabilities and ensure delivery excellence. Build relationships and oversee external vendors and CROs to ensure quality and compliance with timelines and standards. Contribute to departmental strategy, process improvement, and the advancement of statistical methodology and operations. Qualifications and Experience PhD in statistics or related field 10+ years of experience in clinical development within the pharmaceutical or biotechnology industry Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions Experience partnering with cross-functional teams and interacting with health authorities People management experience required; mentorship and team-building strongly preferred Experience managing external partners (CROs, consultants) Exposure to or leadership of statistical innovation initiatives preferred Competencies Strong statistical methodology knowledge and clinical trial design expertise Ability to collaborate and influence across functions and levels Excellent communication and interpersonal skills Experience with CDISC standards, programming oversight, and statistical operations Strategic and analytical mindset with a focus on execution Ability to work in a matrixed environment and lead through influence About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. To start a career that is out of the ordinary, please apply...Job Details Job Title: Senior Director, Client Service, Media Job Location: Hybrid- Atlanta, Boston, Chicago, New York City, Norwalk About the role The Senior Director role is a strategic leadership position responsible for overseeing a portfolio of high-value accounts and guiding strategic account teams. This individual acts as a senior advisor to executive-level stakeholders, influencing investment decisions and driving multi-year growth plans. The role combines deep expertise in media research and analytics with executive engagement and commercial accountability. Primary Responsibilities Oversee a portfolio of high-value accounts; manage and lead small portfolio teams or strategic account teams to deliver exceptional client outcomes. Serve as a senior advisor to executive-level stakeholders; influence strategic investment decisions through evidence-based insights. Accountable for retention of portfolio and responsible for multi-year growth plans, cross-sell strategies, and achievement of significant revenue targets. Lead executive-level research initiatives; synthesize primary, secondary, and advanced analytics into actionable narratives for senior decision-making. Optimize resource allocation and deliver operational efficiency across portfolio teams; shape best practices for quality delivery at scale. Represent Kantar in industry forums and enterprise-wide initiatives; champion innovation in media analytics and cross-platform measurement. Develop and nurture high-performing teams by identifying, mentoring, and advancing top talent through a culture of continuous learning and collaboration. Essential Knowledge & Experience 7+ years in media research, analytics, or consulting with proven success in executive-level engagement. Expertise in digital ecosystems, cross-platform measurement methodologies, creative quality, and/or placement and audience insights. Strong command of advanced research techniques, including attribution, ROI modeling, and audience segmentation. Advanced ability to synthesize complex data into compelling narratives for executive audiences. Proven ability to shape strategic investment decisions and drive commercial outcomes. Track record of delivering multi-year growth plans and achieving significant revenue targets for an account portfolio. Demonstrated success in managing senior client relationships and leading high-performing teams, including direct management of a team of 3 or more professionals. Ability to navigate fast-paced agency or complex client environments, balancing strategic depth with delivery efficiency. Bachelor's degree in market research/marketing or related social science and analytic subject areas. Masters preferred Location New York, World Trade CenterUnited States of America Kantar Rewards Statement At Kantar we have an integrated way of rewarding our people based around a simple, clear and consistent set of principles. Our approach helps to ensure we are market competitive and also to support a pay for performance culture, where your reward and career progression opportunities are linked to what you deliver. We go beyond the obvious, using intelligence, passion and creativity to inspire new thinking and shape the world we live in. Apply for a career that's out of the ordinary and join us. We want to create an equality of opportunity in a fair and supportive working environment where people feel included, accepted and are allowed to flourish in a space where their mental health and well being is taken into consideration. We want to create a more diverse community to expand our talent pool, be locally representative, drive diversity of thinking and better commercial outcomes. Kantar is the world's leading data, insights and consulting company. We understand more about how people think, feel, shop, share, vote and view than anyone else. Combining our expertise in human understanding with advanced technologies, Kantar's 30,000 people help the world's leading organisations succeed and grow.

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three days onsite. Responsibilities: • As the epidemiology lead for designated products proactively define epidemiology research strategies to contribute to R&D and Commercial objectives. • Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports. • Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests). • Lead structured benefit-risk assessments, using qualitative and quantitative methods. • Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company. • Assist the head of department to facilitate ongoing development and growth of the department. • Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. Qualifications: • Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master's degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry. • Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products. Ability to proactively advise and lead product teams in this regard. • Sustained autonomous performance as epidemiology lead to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity. • Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting. • Demonstrated experience leading organizational process improvement or change management initiatives. • Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities. #LI-HYBRID About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

Lead the Project Management Office for R&D Main Responsibilities & Accountabilities ••Leads PM office which will elevate the craft of all Project Managers in RD by steadily training the best personal practices, tools and methods to an end-to-end community of PM•Challenges the broader organization to be more project centric through outside in thinking, proposing process/culture/governance changes as part of the PPE group.•Provides direct management oversight of PMO group, China PM team (2), Submission PM (4 FTE + FSP) and dotted line reporting for Japan PM (4 FTE); through this ensures that all projects get consistent specialty support from these groups, and that their practices and resources meet the needs of the R&D portfolio.•Provides and trains R&D Project Managers in fit for purpose Tools, Templates and PM learning function that enable RD& projects to be planned in a consistent manner, that meets the needs of the organization for risk management, budget, critical path / timelines and resourcing issues. Qualifications & Experience Requirements •12+ years in R&D project Management or operations•Expert, first-hand knowledge of PM best practices, tools, templates and training groups on these•Experience working in cross-functional R&D teams•In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals•An advanced degree in Science, Master of Business Administration (MBA), PMP certification, or equivalent is a plus.•Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.•Involvement in cross-functional, multicultural and international teams preferable.•Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences•Excellent Strategic Thinking skills•Significant experience in the application and utilization of portfolio management systems and software••About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

Associate Director, Contracts and Pricing Department: Market Access About Our Client Our client is a global leader in healthcare innovation, focused on improving patient access and delivering value through science and technology. They operate across prescription medicine, consumer health, and specialty care, driving growth through strategic partnerships and cutting-edge solutions. Job Summary The Associate Director, Contracts and Pricing - Prescription Business Unit (U.S.) will lead initiatives to develop, model, execute, and measure access and reimbursement strategies. This role ensures successful product launches, maximizes market adoption, and supports lifecycle management from early development through loss of exclusivity. Key Responsibilities Achieve financial targets: manage forecasts, invoices, accruals, and validation through budgeting and financial review processes. Oversee market access and reimbursement operations, including managed care contracting, payer negotiations, and rebate budgets. Lead Gross-to-Net modeling for portfolio and new launches; develop robust forecasts using contract data and insights. Collaborate with leadership and cross-functional teams to align on market access strategies and GTN assumptions. Serve as SME for payer negotiations; assess risks and opportunities to inform contract terms and conditions. Manage communication plans, KPI reporting, and compliance with healthcare regulations. Support business development and new product launches with market access assessments and go-to-market strategies. Qualifications Strong experience in market access, pricing, and contracting within the pharmaceutical or healthcare industry. Expertise in financial modeling, forecasting, and payer negotiations. Ability to manage complex projects and collaborate across functions. Excellent analytical, communication, and strategic thinking skills.

Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences(DQS) is committed to harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. Delivery & Business Accountabilities: Lead delivery for one or more assets at GPT level or specialty area in clinical Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them Contributions: Asset-level GPT strategy and delivery Broadly DQS functions Parts R&D functions. Core Elements Related to this Role: Advanced knowledge of clinical study designs, analysis methodology and data interpretation. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function. Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. Strong statistical programming skills Excellent oral and written communications skills. Specialized statistical expertise in multiple therapeutic areas or development phases. Strong inter-personal and people management skills. Strong project management skills. Strong collaborative skills and ability to work with a cross-functional team. Technical/Functional (Line) Expertise: Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs that he/she is involved in Leadership: Lead one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Create an internal and external sphere of influence in area of expertise Education: PHD with ~ 5 years experience MS with ~ 8+ years experience Behavioral Competencies: Inspire teamwork Assess benefit risk of options Develop understanding of business beyond SQS Focuses on priorities

Title: Associate Director of Regulatory Strategy A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development. Key Responsibilities Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning. Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters. Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor. Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements. Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities. Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation. Qualifications Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development. Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies). Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA). Familiarity with 505(b)(2) development strategies or innovative delivery platforms. Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas. Proven track record of successful interactions with the FDA and/or global regulatory agencies. Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies. Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.

San Francisco, CA - Hybrid $200,000 - $250,000 Director, Clinical Operations - Emerging Metabolic Biotech Join an early-stage biotech on a mission to transform metabolic disease treatment. Our client is building a first-in-class metabolic pipeline and seeking a Director of Clinical Operations to lead the execution of thier initial clinical programs. What You'll Do Own end-to-end clinical operations strategy and delivery for early-phase trials. Select and manage CROs, vendors, and sites to ensure quality and timelines. Drive inspection readiness and compliance across global studies. Partner cross-functionally with Clinical Development, Regulatory, and CMC teams to shape program strategy. What We're Looking For 10+ years in clinical operations with proven leadership in early-phase studies. Experience in metabolic or related therapeutic areas strongly preferred. Ability to thrive in a fast-paced, resource-conscious environment. Hands-on approach with strategic vision-comfortable building processes from the ground up. This role offers the opportunity to contribute to groundbreaking therapies in a dynamic and innovative environment. If you are passionate about clinical operations and making a difference in patients' lives, we encourage you to apply.

Base Salary: $145K-$215K USD + Bonus | Full-Time | Remote A fast-growing, clinical-stage biotech is redefining treatment paradigms with cutting-edge bispecific antibody therapies for immune and inflammatory disorders. Backed by strong investors and powered by a lean, agile team, this company is on a mission to deliver transformative biologics for patients with complex immune-mediated conditions. Be part of a team where innovation meets purpose-and help shape the next generation of therapies. Key Responsibilities Lead and oversee global Phase I-III clinical trials across immunology and inflammatory indications. Manage CROs and specialty vendors, ensuring adherence to GCP, ICH, and regulatory standards. Own budgets, timelines, and risk mitigation plans for all clinical programs. Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality teams. Drive inspection readiness and ensure audit preparedness. Qualifications Minimum 8 years of clinical operations experience in biotech/pharma, including 3+ years in a leadership role. Proven track record managing global trials and CROs. Strong knowledge of GCP, ICH, and regulatory requirements. Immunology or inflammatory disorder experience preferred. If you or someone you know fits this experience and shows interest, we'd love to speak with you!

Ipsen's Rare Disease franchise has been expanding through both organic growth and acquisitions. From a marketing standpoint, there is a critical need for excellence in strategic planning and in execution to clearly define how we will best drive education of appropriate healthcare providers, deliver successful launches, and win in highly competitive spaces. The Associate Director, HCP Marketing, PBC is a key role on the Rare Disease Commercial Team and will report to the Iqirvo Brand Lead. The AD will support US marketing initiatives and key promotional activities to help the Rare team achieve near-term revenue goals and support the ongoing successful launch of Iqirvo. Responsibilities will encompass traditional HCP marketing including brand planning, development of materials and messages for multichannel engagement focused on congresses, advisory boards, peer to peer educational programs and KOL engagements. The role will include execution of both personal and non-personal promotional tactics. The AD will collaborate with the Thought Leader Engagement Team, Field leadership, Sales training, Medical Affairs, Legal & Business Ethics to execute tactics focused on HCP Marketing. Main Responsibilities & Job Expectations: Core Marketing Activities Lead key initiatives to implement tactical HCP Marketing plan Development & execution congress marketing plans & materials Speaker bureau content strategy, training, execution & ongoing management Advisory board planning and execution Amplify peer to peer messaging through multichannel engagement tactics Develop and monitor KPIs for brand tactical plan and communicate performance vs leading and lagging indicator to Rare disease leadership Contribute to Brand Planning and Tactical Plan development for Iqirvo Ensure compliant execution of all promotional activities Collaborate with: Rare disease field leadership to provide support with sales force execution and gain feedback and insights to adjust and enhance materials / messages Other brands teams within marketing to ensure cohesive delivery of portfolio strategy and unified external voice to customers Thought Leader Liaison team & Sales Leadership on marketing material development, execution and performance Promotional review committee to ensure compliant development of field resources in line with the strategy Business ethics & legal team to ensure compliant development and implementation of projects Cross Functional Collaboration & Stakeholder Management: Incorporate insights from primary and secondary research into development of field promotional tactics Share leadership responsibilities for regular cross-functional meetings including congress planning, bureau operations and brand team meetings Work with advanced analytics to ensure appropriate understanding and implementation of brand strategy. Knowledge, Abilities & Experience: BA/BS is required: PharmD or MBA preferred At least 10 years of experience in commercial pharmaceutical roles, with a minimum of 5 years in marketing Successful launch experience in the rare of specialty categories, hepatology would be a strong plus Excellent leadership, strategic planning, and project management skills Proven track record of developing and executing successful healthcare professional (HCP)marketing strategies Strong understanding of the rare disease landscape and patient needs Excellent communication and interpersonal skills along with the ability to influence others Ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously Strong analytical skills with the ability to interpret data and make informed decisions Knowledge of the AMA, ACCME, PhRMA and FDA regulations associated with promotion and industry-supported scientific education activities Able to work from our Cambridge, MA HQ on a hybrid model including 2-3 days in office Willingness to travel, including international, when needed The annual base salary range for this position is $151,500 to $222,000 This job is eligible to participate in our short-term incentives program. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

Head of Analytical Development: NYC We are seeking a Director or Senior Director of Analytical Development to lead and expand the analytical development function. This individual will play a pivotal role in supporting late-stage programs, ensuring robust analytical strategies for drug substance and drug product, and driving method development, validation, and transfer activities. This is a hands-on leadership role for someone who thrives in a dynamic environment, enjoys rolling up their sleeves, and is committed to building best-in-class analytical capabilities. The ideal candidate will be comfortable commuting to the New York site four days per week and collaborating cross-functionally with CMC, Quality, and external partners. Key Responsibilities Lead the Analytical Development team responsible for method development, qualification, validation, and transfer for drug substance and drug product. Develop and implement analytical strategies to support late-stage development, scale-up, and commercialization. Oversee characterization studies, stability programs, and specification setting in alignment with regulatory requirements. Partner closely with Process Development, Quality, and Regulatory teams to ensure seamless integration of analytical deliverables. Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met. Provide technical leadership and mentorship to a growing team, fostering a culture of scientific excellence and accountability. Contribute to regulatory submissions (IND, NDA) and represent Analytical Development in health authority interactions as needed. Qualifications Ph.D. or M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline. 10+ years of experience in analytical development within the biotech or pharmaceutical industry, with a strong focus on small molecule late-stage development and commercialization. Proven track record of leadership in method development, validation, and transfer for complex modalities (biologics experience strongly preferred). Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for global filings. Excellent communication and collaboration skills; ability to work effectively in a fast-paced, matrixed environment. Willingness and ability to be onsite in New York 4 days per week. Why Join? Opportunity to shape analytical strategy for a late-stage pipeline with high-impact programs. Work in a well-funded biotech with strong pharma partnerships and a clear path to commercialization. Collaborative, science-driven culture where your contributions make a tangible difference.

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

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

Director 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.

Associate Director, Commercial Training & Field Effectiveness LinkedIn Twitter Email Message Share Commercial Operations Cambridge, MA * ID: 25R-32 * Full-Time/Regular Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease. This is life-changing work, and we are all in, are you? Job Summary Reporting to the Sr. Director of Commercial Excellence, the Associate Director of Field Engagement and Effectiveness is responsible for gathering field insights regarding launch effectiveness requirements, developing commercial & sales training programs and delivering operational support to the customer-facing roles. This will include disease state, product/therapeutic landscape knowledge, compliance (OIG), and other commercialization processes and systems. The incumbent will need to collaborate across Medical, Marketing, Sales, Market Access, Legal, People and Culture, Regulatory, and other Partner Organizations. Training (50% of the time) Aligning to Akebia's annual strategy for sales and marketing focus Develop a sales training curriculum that motivates customer-facing personnel to achieve their goals and align with the strategy. Establish a collaborative, clinical, sales focused learning environment with core principles of adult learning Optimize curriculum that allows ongoing education for customer-facing teams to ensure consistency in disease state and product knowledge. (product/non-product training modules) Lead and coordinate new hire onboarding and training programs for customer-facing teams. Collaborate with Subject Matter Experts (SMEs) to create the appropriate learning content for the respective customer-facing role. Direct Field Trainers who will be peer-to-peer trainers with their colleagues within the sales team. Liaise with home office/field management about the development and delivery of training material. Document and maintain proper records of training initiatives. Collaborate with the administration of the Promotional, Medical, Legal, & Regulatory (PRC) process to identify the training requirements and the delivery of material for use. Support efforts in Company meeting planning and execution, including agenda creation, workshop development, and delivery as well as overall meeting facilitation for POAs & NSMs. Manage vendors and partners to produce meaningful curriculum within established scope and timeframes. Perform additional responsibilities and participate in special projects as assigned. Field Effectiveness Insight Generation (30% of the time) Work with Sales Leadership Team to review team effectiveness with the aim of identifying performance gaps and create sales tactics and/or training programs to address them. Interpret sales data and KAM call information to develop appropriate training reinforcement and development plans. Perform ride along with KAMs to provide feedback on promotional effectiveness, customer engagement and territory management. Develop and implement KAM feedback tool to provide written feedback to KAMs to highlight performance attributes affecting promotional success. Develop and manage feedback from sales organization on key initiatives Engagement Effectiveness Administration (20% of the time) Manage Learning Management System (Akebia Learning) partnering closely with Compliance, Commercial and Human Resources Participate in the implementation/deployment of technologies (Veeva CRM, Sales portal) to be used by the field force to increase efficiency, and effectiveness and determine the best way to train the team. Requirements Bachelor's degree required. 8+ years' experience in a commercial role within a pharma or biotech company and at least 5 years in a sales/product training-focused role. Previous Experience in building a sales training continuum for a life science company Proficient in Microsoft Office Suite, including PowerPoint, Excel, and Word Proficient in sales reporting and analytics tools (e.g., Tableau), as well as CRM and Learning Management Systems (LMS) Demonstrated experience with best-in-class means of training delivery including eLearning, self-study, assessment, audio/video, classroom, and experiential learning to ensure the sales force is trained and can deliver the attributes of our products. Strong interpersonal, presentation and facilitation skills required. Previous field sales experience is strongly preferred. Demonstrated success in managing numerous projects simultaneously. Ability to challenge the thinking of an established customer facing team. Requires 15-35% travel. Compensation: Targeted Base: $171,290 - $211,593* *Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc. Are you an Akebian? An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: ************** Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law. RequiredPreferredJob Industries Other

Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed. 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. We are seeking a Director level Clinical Scientist who can oversee all clinical aspects of a clinical trial(s). This would include: planning and authoring of clinical deliverables (protocols, amendments, medical monitoring plans, annual reports, study-specific updates, CSRs), routine medical monitoring, site interaction / correspondence re: patient eligibility and treatment inquiries, and presentations both internal and external. As an Associate Director within Clinical Science, you'll play a critical role ensuring study protocols are executed appropriately and that the study data is both appropriate and pristine. On a daily basis, you will interact cross-functionally with multiple disciplines supporting the Study Team (Clinical Operations, Medical Director, CMC, Data Management, CROs, CRAs, Investigative Sites, etc). You'll be responsible for reviewing and cleaning / querying pertinent data points, identifying trends or inconsistencies with the data, and serving as the face of the study to Investigative Sites. You can expect to work on multiple early-phase projects at the same time in a fast-paced and exciting environment where the ability to multi-task and rapidly re-organize thoughts and priorities will be essential. In this role, you will: * Create - Serve as the authoring lead on multiple clinical documents. Recursion is moving away from the use of Medical Writers and relying more heavily on the Clinical Scientist and Medical Director to author IND and study specific documents. While this will not refer to manuals it does encompass Clinical documents and site / agency interactions. * Collaborate - Work with highly dynamic teams where your role will range from leading and owning decisions or timelines to being a key contributor whose experience and insight are relied upon to advance the task at hand. * Drive & Deliver - You will be primarily responsible for the quality of your study data. This will include reviewing (Medical Monitoring); issuing, reviewing, and closing queries; reviewing TLFs, summarizing data throughout the trial, and presenting the data to management when requested. You will also be required to present the protocol procedures and Site Initiation Visits both in-person and virtually. * Prioritize - Given the nature of Recursion, you will be required to support multiple early phase (1-2) studies simultaneously. This will require time management and organizational skills. The Team You'll Join Reporting to the Vice President, Clinical Science, you'll be joining the Clinical Science Team within Clinical Development. This group is ultimately responsible for shepherding an experimental drug from IND through Dose Finding, Proof of Concept, and possibly Registration studies. Clinical Science consists of a high performing Team of extremely motivated individuals who work independently, interact cross-functionally with many contributing departments, and are capable of multi-tasking to expeditiously execute cutting edge clinical trials. The Experience You'll Need * 5+ years as a Clinical Scientist in a pharmaceutical or biotech company * Prior experience in early phase 1-2 oncology studies is required. * Experience with hematologic malignancies is preferred. * Strong interpersonal and communication skills (both spoken and written) - with ability to effectively communicate on project planning, progress, tracking etc. * Strong relationship building skills to work effectively with others in various disciplines and levels * Proven ability to manage multiple, complex, and competing priorities to effective and efficient conclusion * Ability to operate strategically and tactically * Proven ability in problem solving and issues management that is solution focused Working Location: This is an office-based, hybrid role in our Salt Lake City / New York City office. 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 $180,600 - $229,000 (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.

Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed. The Impact You'll Make We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs. Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary. Format and publish regulatory documents at the document level in accordance with health authority requirements and the appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post-publishing. Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies. Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. The interactive on-going trackers should be updated regularly. Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.) Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution. Stay updated on local and global regulatory submission requirements and implement new publishing requirements. Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents. The Team You'll Join Reporting to the Vice President, Regulatory, you'll be an integral part of the regulatory team leading regulatory operations and intelligence function. On the diverse team, you'll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion's regulatory strategy along with leading the intelligence function to disseminate impact from regulatory changes across different regions. The Experience You'll Need Master's or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered. 7+ years of industry-related experience in a regulatory publishing function. 5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo). Experience with setting up regulatory intelligence functions and tools is a must. Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus. Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers. Experience interacting with health authorities for operational systems is preferred. Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus. Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust. Critical thinker with excellent attention to detail. Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM). Experience in project management is a plus. Working Location & Compensation: This is an office-based, hybrid role in our Salt Lake City / New York City office. 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 $175,400 - $206,400 (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.

Your work will change lives. Including your own. Please note: Our offices will be closed for our annual winter break from December 22, 2025, to January 2, 2026. Our response to your application will be delayed. The Impact You'll Make We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs. * Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary. * Format and publish regulatory documents at the document level in accordance with health authority requirements and the appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post-publishing. * Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies. * Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. The interactive on-going trackers should be updated regularly. * Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.) * Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution. * Stay updated on local and global regulatory submission requirements and implement new publishing requirements. * Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents. The Team You'll Join Reporting to the Vice President, Regulatory, you'll be an integral part of the regulatory team leading regulatory operations and intelligence function. On the diverse team, you'll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion's regulatory strategy along with leading the intelligence function to disseminate impact from regulatory changes across different regions. The Experience You'll Need * Master's or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered. * 7+ years of industry-related experience in a regulatory publishing function. * 5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo). * Experience with setting up regulatory intelligence functions and tools is a must. * Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus. * Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers. * Experience interacting with health authorities for operational systems is preferred. * Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus. * Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust. * Critical thinker with excellent attention to detail. * Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM). * Experience in project management is a plus. Working Location & Compensation: This is an office-based, hybrid role in our Salt Lake City / New York City office. 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 $175,400 - $206,400 (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.

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit****************************** more information. The Associate Director (AD), Market Access Marketing - Sleep will support the Sleep Franchise team with a remit of optimally positioning Jazz products to enable patient access in an increasingly challenging and evolving US access landscape. The AD, Market Access Marketing - Sleep will report to and primarily function as strategic support to the Director, Market Access Marketing - Sleep and lead the tactical execution in support of brand strategy. The AD is responsible for the implementation of the payer value proposition and promotional/non-personal tools and tactics for use with third party payers. In addition, this individual will work cross-functionally with various field teams including Payer Account teams, Field Access and Reimbursement teams, and Field Sales teams to ensure they are equipped with programs, tools, resources, and messaging to optimize customer engagement and ensure patient access. Key Responsibilities Strategic Thinking: Think strategically across indications to identify opportunities to align and further complement efforts to maximize value communication Brand Plan Execution: Work with the marketing team and other stakeholder functions to execute and refine brand tactical plan with the goal of driving both awareness and perception of access among target audiences; participate in the development and execution of the annual brand planning process. Build, coordinate, and orchestrate a cross-functional view of full market access activities and activations Value Communication: Craft compelling payer value propositions, messaging platforms, and tools that resonate with key stakeholders including payers, providers, healthcare decision-makers Resource Development: Create innovative tools and materials (e.g., pull through materials, resource guides, AMCP dossiers, value decks, field training modules) to support field teams in effectively communicating product value and outcomes Cross-Functional Collaboration: Partner with Market Access, HEOR, Medical Affairs, Regulatory, Compliance, Brand Marketing, and Sales teams to align access strategies and ensure consistent execution Insight Generation: Conduct primary and secondary research, analyze relevant data, and monitor competitive and market trends to generate meaningful payer/HCP insights for use in business decision-making Performance Measurement: Lead the development and coordination of performance measurement and reporting across responsible assets and KPIs to ensure access messaging is effectively delivering on brand access objectives Qualifications Bachelor's degree required; advanced degree (MBA, MPH, PharmD) preferred 7+ years of combined experience in pharmaceutical marketing, market access, or related field 4+ years of experience in Market Access Marketing, Patient Support Services, and/or Payer Account Management Deep understanding of the U.S. healthcare landscape, including payer dynamics and reimbursement pathways Thorough understanding of processes to develop and obtain approval of promotional materials, including navigating Medical, Regulatory, and legal reviews Strong communication, analytical, and project management skills Ability to thrive in a fast-paced, matrixed environment Pharmaceutical career progression that demonstrates growth in responsibility and scope, particularly in commercial Market Access positions The position will be primarily home based, with the expectation that the person is willing to travel to meetings as necessary Preferred Specialty pharmaceutical Market Access related experience Specialty/retail pharmaceutical Marketing related experience #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $162,400.00 - $243,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: ********************************************* RequiredPreferredJob Industries Other