Astellas Pharma jobs

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Cambridge, Massachusetts. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Research Strategy Lead, Oncology Research Intelligence reports to the Head of Competitive Intelligence (CI) & Research Program Management (RPM). This role is a strategic role within the CI & RPM in Oncology Research, responsible for developing actionable strategies in key therapeutic areas such as immuno-oncology (IO) or tumor-targeted therapies in Oncology. This role integrates deep scientific expertise with strategic thinking to shape a future-ready oncology research pipeline. Through rigorous internal and external landscape analysis, the Research Strategy Lead informs research direction, portfolio differentiation, and early innovation targeting. The Research Strategy Lead collaborates closely with the Strategy Integration Lead, Oncology Research Leadership, and other cross-functional stakeholders to ensure research and portfolio alignment, enhancing the impact, agility, and future-readiness of the oncology pipeline. Essential Job Responsibilities: Strategic Planning & Portfolio Guidance: Lead the development of therapeutic area-specific research strategies grounded in both internal capabilities and external innovation signals in alignment with Astellas' long-term relevant Primary Focus (PF) area goals. Deliver actionable insights and foresight to the Head of CI & RPM, Oncology Research leadership and PF Leadership Team to guide prioritization, differentiation, and long-term planning based on deep insights into competitive dynamics, scientific trends, and unmet needs. Translate macro-level strategy into clear scientific focus areas, roadmaps, and research hypotheses for research teams. Act as a strategic thought partner to the Head of CI & RPM, integrating intelligence into portfolio prioritization, resource planning, and innovation decisions. Lead horizon scanning efforts to identify emerging opportunities and risks to maintain a future-ready research organization. Competitive Intelligence & Strategic Foresight: Oversee continuous monitoring of the oncology landscape, including pipelines, scientific breakthroughs, partnerships, and regulatory changes. Ensure synthesis of data into insights that clearly highlight risks and opportunities for Astellas' oncology research pipeline. Support early evaluations of external opportunities to External Innovation Partners, Modality Intelligence Leads and Innovation Intelligence Analysts by providing strategic context and scientific framing. Collaborate with Strategy Integration Lead to support the development of strategic playbooks and investment theses that inform internal program direction and external innovation targeting. Operational Excellence & Intelligence Infrastructure: Establish and continuously enhance best practices for strategic intelligence gathering, synthesis, and insight dissemination to support data-driven decision-making. Promote the effective use of digital platforms, analytics tools, and dashboards to accelerate insight generation and improve strategic responsiveness.

Compensation Data Compensation: This position offers a base salary typically between $140,000 and $219,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director, National Acct and Sales Retail is responsible for the management of the assigned Customers and account managers. The incumbent will develop the retail strategy for their relevant channel of assigned customers, and the implementation of the Boehringer sales/marketing plan to assure maximum distribution and market penetration of Boehringer products. Responsibilities for this role include achieving net sales, profit, and market share goals, and delivering against customer KPIs. The incumbent will manage a team of account managers, across relevant portfolio of customers. This role will support the leadership of the sales functional by developing key internal relationships, as well as external. This position has responsibility for key additional projects which support the continued development and future strategy of the sales organization. Remote based role. Locations: Duluth, GA or Seattle, WA Duties & Responsibilities Works with and through assigned customers and Key Account Managers to ensure sales performance meets or exceeds annual Company sales and market share objectives. Implements a sales strategy to be executed through their relevant channel and Key Account Managers. Exercises fiscal control on allocated operating budgets across multiple customers. Manages across multiple customers. Responsible for setting of annual KPIS. Works to improve to sales bench of the organization, with the Head of Sales. Utilizes appropriate data sources to develop tactical plans and to develop future customer / channel strategy. Actively monitors progress of work, cross-functional activities, and accountability. Plans and executes meetings that effectively implement objectives and strategies as determined by the Company. Spends appropriate amount of time developing customers, networks, and their relationships to foster Company business. Leads the senior customer engagement strategy across the channel, ensuring relevant T2T, strategic customer meetings and line reviews are delivered. Develops positive relationships with Company internal customers, such as supply, marketing, Segment Leads. Performs all Company business in accordance with all regulations (e.g., EEO, FDA, OSHA, etc.) and Company policies and procedures. Demonstrates high ethical and professional standards with all business contacts to maintain BIAH's excellent reputation within the community. Leads special strategic projects as relevant, which will ensure future success of the retail sales team. Requirements BS/BA. Minimum of eight to ten (8-10) years successful commercial industry experience. Minimum of five to seven (5-7) years retail experience, across Omni channel, ideally in US Mass market, E-commerce, or Retail Pharmacy. Understanding of retail analytics, economics, supply chain, and consumer insights. Understanding of the digital environment, e.g., E-Commerce and digital marketing. Understanding of the US retail environment. Experience in working cross-functionally. Project Management Skills. Proficiency in Excel, Word, Outlook, PowerPoint, and database applications. Ability to travel. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

**Compensation Data** This position offers a base salary typically between $220,000.00 and $350,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** . **Description** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Group Lead, Medical Writing ExpMED, is accountable for the organizational set up, development, implementation, and oversight of a high-performing, innovative Medical Writing group for the early phase, and the development and oversight of an ExpMED Medical Writing excellence strategy (i.e., acceleration of clinical development timelines, use of AI, and creation of patient value while maintaining high quality) via strategic planning and execution of early clinical documents across all Therapeutic Areas. The Group Lead, Medical Writing ExpMED, in alignment with Head of ExpMed Clinical Operations (ExpMED CO) and ExpMED Leadership team, contributes to overall ExpMED strategy. The Group Lead provides leadership and guidance to a diverse team, creates an environment that inspires, motivates, and empowers colleagues, fosters a culture of continuous learning, knowledge sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and the organization. **Duties & Responsibilities** - Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas. - As part of the ExpMED Clinical Operations department, you will build and continuously enhance a high-performing and innovative global Medical Writing team. - Accountable for the creation and continuous refinement of a world-class ExpMED Medical Writing (MW) department to effectively deliver in the early phase. - Accountable for talent attraction, development retention, and succession planning within ExpMED (MW), in close alignment with HR. Group Lead MW in close alignment with other members of the ExpMED CO Leadership team, is responsible for functional talent development within ExpMED CO. - Accountable for the creation of an environment that inspires, motivates, and empowers colleagues within ExpMED MW to accelerate clinical development timelines and to create value for patients and the healthcare system. - Accountable that staff is well trained and qualified; supports staff in technical and personal skills development to support career progression. - Leads the communication of scientific programs and holistic evidence to key stakeholders, including investigators, regulators, payers, patients, and caregivers. - Oversees capacity planning, financial management, and the strategic deployment of internal and external (CRO) resources to support clinical program needs. - Provide oversight to constantly improve ExpMED MW processes and standards to prevent and/or remedy quality and/or compliance findings (in-house and/or CRO setting) to ensure early clinical execution excellence, in alignment with other Corporate functions. - Representation of Boehringer Ingelheim at external meetings and conferences to create value for Boehringer Ingelheim and external stakeholders. **Requirements** - Minimum of Bachelor's degree required; advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's), strongly preferred. - 10+ years of professional experience in a scientific, clinical, and/or medical space. - Strong leadership skills with the ability to inspire and motivate to build a high-performing, innovative team. - Comprehensive understanding of drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers. - Experience in (at least passion for) storytelling. - Knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements. - Demonstrated experience presenting to scientific and non-scientific audiences. - Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings. - Strategic mindset with the ability to drive innovation, digital transformation, and process integration across complex, global environments. - Expertise in globalizing functions to operate in a standardized fashion. - Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors. - Proactively identify gaps, emerging risks, and opportunities for improvement through ongoing analysis and benchmarking to maintain industry leading position - Encourages the adoption of new technologies, smart risk-taking, and a unified ExpMED CO identity that empowers teams and accelerates clinical development. - Demonstrated ability to build, lead, develop and maintain a high-performance, medical writing team. - **Remote*:** this position is considered remote based. **Eligibility Requirements:** + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the potential strategic impact of critical insights. This territory will be responsible for covering VA / TN. The preferable location for the successful candidate would be to reside in the Nashville, Richmond or Winston-Salem area. Must live within 50 miles of the border of this territory to be considered. Relocation is not available. Role Responsibilities include, but are not limited to * The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy * The primary responsibility of the MSL is to engage with customers - customer engagements may include but are not limited to: emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within their territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle. * Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence on the patient journey and in the disease space throughout the product development lifecycle to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate• Provide clinical trial support for company sponsored trials facilitating relevant medical activities and working cross-functionally with Medical Affairs and Clinical Operations colleagues. * Regularly and effectively collaborates with internal colleagues (e.g., HEOR, access, marketing, commercial, sales) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards. * Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues (in accordance with Working Practice Documents). * Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect day-to-day responsibilities. * Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM. * Champion emerging responsibilities as strategic priorities and territory needs evolve * Proactively drive personal and professional development. The pay range for this position at commencement of employment is expected to be between; for Manager: $166,400 - $249,600 and for AD: $183,200 - $274,800 year however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors About the Role Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc) Experience for Manager Level: * 0-3 years of experience in a Field Medical position within the pharmaceutical industry or as an MSL is required OR * 3-5 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting preferred. Previous experience in assigned or related therapeutic area is preferred. Experience for AD Level: * Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR * 5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Previous experience in assigned or related therapeutic area is preferred. Experience all levels: * Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required. * Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies. * Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around him/her do the same * Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment * Adherence with Company policies, state and federal laws and regulations * Field-Based (Region: covering VA / TN). Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from territory border. * The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager * Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). NOTE: Above level experience criteria are not an exhaustive list Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: ********************************************************** Field roles with a dedicated training period only: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

This role will serve as the Associate Head of Experimental Medicine for a given TA/Function and has overall medical strategic responsibility for Experimental Medicine Oncology / Early Clinical Development Immunotherapy. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities In collaboration with the Head of ExpMED TA and fellow Associate Heads, exert medical and scientific strategic leadership for the Therapeutic Area, with a focus on assets within his/her area of responsibility. Maintain and spread knowledge of scientific developments, (products, mechanisms, methodologies) competitor strategies and external environment developments within his/her area of responsibility. Ensures alignment regarding scientific platforms, medical communication and publication strategies as well as the Product Maintenance and Optimization strategies for each substance or project under their responsibility as delegated by TA HoEM. Review and approve final Clinical Trial Reports, Clinical Trial Protocols, scientific publications according to established procedures as delegated by the TA HoEM. Ensures the review of the Master Plans, related Clinical Development plans and Clinical Trial Protocols and programmes, by the CEG for each substance or project under their responsibility as delegated by TA HoEM. Key decision maker in internal committee discussions Serve as a member of the Therapeutic Area Licensing Advisory team, responsible for preliminary, clinical evaluation of in-licensing opportunities and oversight of in-depth in-licensing evaluations as delegated by the TA HoEM. Manage employees belonging to his/her team and establish and maintain adequate standards of people management e.g. Training and personal development, communication, interface definition and processes. Advise, coach and develop his/her teams regarding the preparation of key deliverables within his/her area of responsibility. Support annual international medical budgeting process as delegated by the TA HoEM. Supports and backs TA HoEM according to individually documented delegation of responsibilities. Requirements MD or PhD from an accredited institution. Sound clinical and scientific experience in Oncology/ Early Clinical Development Immunotherapy with ten to fifteen (10-15) years (combination of hospital, academic and industry experience),inclusive of senior leadership role/s; Clinical / pharma experience in the US a plus Strong track record of designing trials that delivered milestones such as PoC (Proof of concept). Expertise in Oncology translational and clinical research with focus on early clinical development (IND enabling activities through Proof of Concept studies), ideally clinical specialization hematology, oncology or organ specialist. Solid relationships with key stakeholders. Sound medical and scientific leadership - maintains team's focus on high priority items even under constantly changing circumstances. Proven success leading global teams preferred. Pragmatic leader that supports and empowers teams to remove hurdles and resolve issues. Ability to act with grace and resilience under pressure. Excellent communication, negotiation and influencing skills. Excellent cross-functional collaboration skills. Full command of English Language. Excellent presentation, training and facilitation skills. Strong track record of interactions with regulatory affairs authority, international societies and other relevant stakeholders. Situational Responsiveness. Deals with Ambiguity. Constantly learns and improves. Advanced Management and Sound Management Skills. Strong leadership skills. Ability to travel globally required Compensation: This position, Executive Director, ExpMed Oncology Immunotherapy, offers a base salary typically between $250,000.00 and $394,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older. Desired Skills, Experience and Abilities

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Global Precision Medicine Lead role is responsible for the development and execution of biomarker and diagnostic strategies across drug development programs to develop tailored therapies that drive improved patient outcomes. The primary responsibility of a Global Precision Medicine Lead is to bring companion diagnostics through development to approval in collaboration with external diagnostic partners for Oncology and/or Gene Therapy. The role requires strong knowledge and experience in applied biomarker research and companion diagnostics development together with strong personal drive to deliver innovative solutions. Essential Job Responsibilities: * Participates in the development and execution of precision medicine and diagnostic strategies for early and late-stage clinical development programs in oncology and other therapeutic areas. * Contributes to the design of clinical studies that incorporate patient stratification, enrichment and biomarker testing including contribution to the relevant sections of study and regulatory documentation. * Enhances drug success in early development through the implementation of precision medicine strategies to define the relationship between biomarkers and drug efficacy and safety. * Facilitates biomarker testing of patient samples and interprets biomarker data from clinical studies to inform precision medicine and diagnostic strategies and generate data to support health authority submissions. * Leads the evaluation and selection of diagnostic technologies and external diagnostic partners to support drug development programs. * Leads the integration of companion diagnostic studies with drug clinical studies from development to approval through close collaboration with cross-functional teams and external diagnostic partners and vendors. * Ensures compliance with regulatory requirements for diagnostic tests and precision medicine approaches implemented in clinical studies. * Represents development as a subject matter expert on cross-functional diagnostic core teams for late-stage assets to drive successful diagnostic launches. * Supports publication of data from precision medicine research studies.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: Member of cross-functional teams, the primary purpose of the Associate Director is to act independently as Lead Safety Statistician (LSS) / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex/novel work in an established area (safety/clinical/ observational studies, MA tactic, Biomarker & PK/PD Analyses or local project), This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques. The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS or the Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the position can act as global safety statistical lead for a late phase or novel asset or represent Astellas on statistical matters related to safety data, clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders and HTAs. The position may also research innovative solutions and train other statisticians. Essential Job Responsibilities: Provides best in class safety data science and statistical support to the asset level for Astellas drug development programs. For assigned projects, provides all required safety statistical support and deliverables by supervising another statistician, or as a member of study team. Ensures quality and consistency of key safety data science deliverables. Accountable for the Asset Level Safety Assessment Plan (ALSAP). For early or non complex asset, independently provides strategic safety statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs ) including design of studies and analyses requiring advanced statistical methodologies. Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products for a safety purpose. Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results. Presents summary data and analyses to key stakeholders in a compelling and clear manner Ensures availability of safety-related data, biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs. May participate in due diligence activities, reviews safety data and advises company Is responsible to implement, explain and validate complex safety statistical methodology Personal Development / Collaboration Recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards - selection and qualification/audits of vendors) Contributes to the recruitment, training, professional development and retention of statistical personnel. is a member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation.

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka's culture and values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of the clinical trials. This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. You will report to the Senior Director, Biostatistics. **** + Provides statistical analysis plan, including study design, sample size, primary and secondary endpoints, and statistical analysis method in protocol development + As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, annual reports and PSUR + Develops Statistical Analysis Plan (SAP) and mock TFLs for interim or final analyses + Participate strategic planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and publications. + Core team of developing final study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current clinical trial results, regulatory trends and new statistical methods to be applied on his/her assigned therapeutic area. + Attend FDA meetings, FDA advisory boards, or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team and provides expertise and input regarding the statistical analysis, TFLs format and data collection and quality, and overall timeline. + Provides technical supervision over other biostatisticians assigned to his/her therapeutic area and assigns them the statistical tasks. + Takes full responsibility in managing biostatistical tasks (as listed above) for one therapeutic area and provides strategic technical support to other clinical projects. + Provides technical direction to supporting statisticians working on projects on a day-to-day basis. **Qualifications/ Required** **Knowledge/ Experience and Skills:** + Understands the company's products, the competition, and the pharmaceutical industry in general. + Demonstrates a competent knowledge of the company's work tools, processes, and policies. + Maintains a current awareness of new drug developments and statistical methodologies in the business. + Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions. + Effective communications within biostatistics function and with study team and key stakeholders across different functional areas such as clinical, regulatory affairs, asset management, safety and clinical operation. + Familiar with regulatory submission process in US and EU. **Skills** + In-depth knowledge of statistical principles, applications, and SAS/R programming software. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. **Educational Qualifications** + PhD or Master's degree in Statistics or Biostatistics. + Minimum 7 years (PhD) or 9 years (master degree) of experience in the pharmaceutical industry Experience in CNS area is a plus. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Band Level 5 Novartis has an opportunity for an Associate Director, Compliance Inquiries & Audits, who will perform internal investigations and root cause analyses (RCA) of content generated by US Integrated Marketing, as part of the Compliance & Risk Operations team. This role is crucial for resolving deviations related to marketing content, communicating with stakeholders, and discreetly responding to audits and legal queries to ensure marketing compliance, confidentiality, integrity, and operational excellence. The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ for periodic live meetings will be at the employee's expense. This position will require 5-10% travel to various Novartis sites and external locations. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. Job Description Key Responsibilities: Intake and triage of identified content risks, gaining insights into circumstances, mitigators, and break downs for appropriate resiliency strategies Assessing and validating potential policy or process breakdowns through comprehensive fact gathering, including conducting informal interviews and thorough document reviews. Determining the root cause of confirmed breakdowns and mapping corrective actions to address these root causes effectively. Identifying proactive measures to prevent policy or process breakdowns from reoccurring. Ensuring the implementation and follow-through of corrective and preventative actions through necessary follow-up, in partnership with AD, Remediation. Maintaining detailed documentation relevant to potential compliance breakdowns and reporting findings comprehensively, operating with discretion and confidentiality. Identifying appropriate metrics to attach to remediations and measuring the potential effectiveness of these remediations. Assessing data over time to identify trends and opportunities for large-scale remediations and organizational priorities Project management and process ownership, being agile to drive optimization aligned to organizational priorities Essential Requirements: Bachelor's degree in a relevant field (e.g., Business Administration, Risk Management, Compliance, Enforcement). Advanced degree preferred. Minimum of 7 years of experience in a similar role within the pharmaceutical or highly regulated industry, with a strong background in compliance, risk management, and investigations Advanced understanding of how pharmaceutical marketing organization operates and the relevant controls they use to manage risk, including content review and production processes Strong analytical and deductive reasoning skills with strong written communication skills Approachable communication style that respects others and balances firmness with empathy Awareness of the various types of biases and how to ensure they are not introduced into work product Skilled in influencing without direct authority and capable of effectively communicating with individuals at various levels of the company Purpose-driven, high-integrity, clear, and compassionate business partner, positively impacting associate and organizational success Novartis Compensation Summary: The salary for this position is expected to range between $132,300 and $245,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************************ call **************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. *************************************************************************************** Salary Range $132,300.00 - $245,700.00 Skills Desired Agility, Cross-Functional Collaboration, Customer Engagement, Customer Experience, Customer Insights, Data Analytics, Data Strategy, Digital Marketing, Marketing Strategy, Media Campaigns, Product Marketing, Stakeholder Engagement, Stakeholder Management, Waterfall Model

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: This role is an integral member of the Daiichi Sankyo (DS) Global Regulatory Intelligence & Policy, Center of Excellence (GRIP CoE), and is responsible for leading US regulatory intelligence acquisition, analysis, communication, and knowledge management, as well as leading US regulatory advocacy and policy activities for assigned issue sets. The role will work closely with the Vice President, Head of North America Regulatory Affairs, other regional Regulatory Intelligence & Policy (RIP) Leads, and cross functional stakeholders, and will conduct analyses and targeted advocacy via a global lens that ensures US intelligence and policy activities are globally coordinated and globally aligned to achieve maximum impact for patients and Daiichi Sankyo business. Additionally, this role will be responsible for the management and continuous improvement of the GRIP CoE Hub designed to provide global access to critical RIP information and resources. Intelligence: The US RIP lead will: 1) Lead the acquisition, analysis, communication, and knowledge management of US regulatory intelligence (RI); 2) Interpret, analyze, and apply US regulatory intelligence to inform strategic decisions of asset teams and leadership, as well as to inform the development of DS policy positions; 3) Lead the strategic development and implementation of an assigned project portfolio (including the development of technology enabled systems, tools, processes, and key performance indicators) for identifying, analysing, and leveraging changes, trends, and other developments in the regulatory landscape, through a global lens, across all key markets where DS operates. The US RIP lead will leverage a wide variety of diverse internal and external sources, databases and networks, to interpret regulatory information into actionable insights that relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant cross-functional stakeholders, to help inform future DS regulatory/development strategies, activities and ways of working. Policy/Advocacy: The US RPI Lead will lead DS regulatory policy and advocacy activities for an assigned portfolio of policy topics. For assigned US issue sets, this role will be responsible for maintaining and efficiently and effectively communicating the current pulse of the issue, developing the DS US position, contributing to the development of Global Regulatory Affairs positions (and potentially serving as both the US and Global GRIP Lead on assigned topics), leading public commenting and other advocacy on assigned topics to ensure that DS has a voice in defining and shaping new or proposed FDA regulatory opportunities/changes/requirements (policy, regulations, guidance, pilots, workshops, etc.), and for preparing DS teams to efficiently navigate these changes to seize opportunities and to mitigate risk. Policy/advocacy activities will include but are not limited to partnering with regulators, interacting and influencing trade associations and other key external stakeholders, securing and executing opportunities to present and publish externally, briefing senior leaders, regulatory affairs teams, and other relevant functions, as well as contributing to the development and execution of assigned global regulatory policy activities. US Focus but with Global Lens/Mindset: While the core responsibilities are US focused, the US Lead will routinely engage with other regional leads and global subject matter experts in regulatory and other DS partner functions to ensure intelligence is analyzed via a global lens and that DS policy development considers the global environment and implications to maximize the impact of intelligence analysis and policy shaping activities. The US Lead may also serve as the global policy lead for specific assigned issues and will contribute to the GRIP CoE's global deliverables. The US Lead will also have a key role in cross-region mentoring and development activities. Stakeholder Engagement: The role will engage internal/external stakeholders from across functions on key regulatory topics, particularly related to biologics/oncology, including coordinating GRIP CoE activities with RA-CMC, R&D & corporate affairs as needed. Responsibilities: Regulatory Intelligence (RI) - Lead the monitoring, collection, synthesis, analysis, communication, archiving, and retrieval of key regulatory intelligence in a systematic manner for the US region, (and for a limited number of global issue sets driven by US FDA regulatory policy). - Transform regulatory information into actionable insights specific to Daiichi Sankyo, that will facilitate the rapid and efficient development and approval of Daiichi Sankyo medicines. - Contribute US regulatory intelligence content and perspective into deliverables (e.g., Quarterly GRIP Insight Reports, Ad Hoc GRIP CoE Alerts Notes; Quarterly Global SOP Committee Updates; and other fora as assigned). - Deliver insightful, proactive (e.g., from routine monitoring of priority issues) and responsive RI and analysis (e.g., in response to internal asset team and GRA Leadership queries), both through a global lens. - Leverage RI analyses to inform strategic decisions at both asset and above asset levels (e.g., using external/internal precedence, case studies, statements from regulators, etc.). - Leverage regulatory intelligence to inform the development and successful execution of Daiichi Sankyo regulatory policy goals. - Develop and maintain strong collaborative networks/relationships with cross-functional subject matter experts (SMEs) and Daiichi Sankyo partner functions that generate, analyze, and consume intelligence. - Leverage and maintain expert proficiency in the use of internal and commercial third-party RI tools, and mentor others to use. - Lead the development, implementation, maintenance, and continuous improvement of assigned elements of GRIP infrastructure (e.g., systems, tools, and processes) that enhance the efficiency and impact of the GRIP deliverables and team. - Contribute to the efficient global operation and continuous improvement of the GRIP CoE (e.g., key performance indicators, team meetings, mentoring, representing the GRIP CoE on cross-functional GRA and intel projects, vendor interactions). - Regulatory Policy Prioritization: - Identify and establish a focused set of US Regulatory Policy priorities for external engagement that are aligned with DS functions and leadership, and will have maximum positive impact on patients and accelerating the delivery of the DS portfolio. Horizon scan for emerging US regulatory policy topics; adjust priorities as needed. - Lead DS regulatory policy and advocacy activities for assigned portfolio of policy topics. For assigned issue sets: - Monitoring Communication: Efficiently and effectively monitor communicate the current pulse of priority issues to Daiichi Sankyo stakeholders via a global lens that includes global context and implications (e.g., briefings to senior leaders, including in advance of trade association interactions). Prepare Daiichi Sankyo teams to efficiently navigate policy/regulatory changes to seize opportunities and to mitigate risk. - Position Development: Develop US regulatory policy/position papers, in partnership with Daiichi Sankyo subject matter experts, ensuring alignment with key stakeholders internally to ensure a unified voice for subsequent Daiichi Sankyo advocacy. Lead or contribute to development and finalization of DS Global Positions. Potentially serve as both US Global GRIP policy lead on assigned topics. - Advocacy: Develop and execute strategic advocacy plans to achieve policy-shaping objectives for key policy topics, and grow the positive reputation of DS. Position paper messaging to drive policy shaping initiatives across multiple channels. Leverage and partner with Daiichi Sankyo cross-functional leaders and subject matter experts (e.g., from across RD, Safety, Tech/Supply and Commercial) to engage externally and increase the impact of DS advocacy. Engage with key external stakeholders including regulators and trade associations to advance and secure the adoption of the Daiichi Sankyo perspective on priority issues. Lead public commenting and other advocacy to ensure that Daiichi Sankyo has a voice in defining and shaping new or proposed FDA regulatory opportunities / changes /requirements (policy, regulations, guidance, pilots, workshops, etc.). Secure and execute opportunities for GRIP as well as other Daiichi Sankyo GRA and cross-functional leaders and subject matter experts to present and publish externally with regulators and/or other influential organizations. Reports back key insights to the GRA Leadership Team and other relevant stakeholders to inform strategic decisions. Tracks impact of advocacy efforts and applies learnings to continuously refine policy messaging and tactics to increase the impact and likelihood of success. 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): - Bachelor's degree in medicine, life sciences, health or related field required - Advanced degree E.g., Masters, Pharm.D., Ph.D., MD, JD preferred Experience Qualifications: - 7 or more years' experience in biopharma Regulatory Affairs, with at least 3 years developing regulatory strategies incl. successful delivery of regulatory projects submissions, and a working knowledge of US FDA regulations and guidelines regarding drug development, regulatory submissions and corresponding regulatory agency interactions required - 4 or more years' experience: 1) Leading and executing Regulatory Intelligence (RI) & Policy activities in the U.S., incl. monitoring, collecting, synthesizing, analyzing, communicating, and managing RI in a systematic retrievable manner for the US region, and 2) Leading and executing US Reg Policy activities, incl. partnering with regulators; coordinating engagement with and influencing trade associations and other key external stakeholders; securing and executing opportunities to present and publish externally; briefing senior leaders, regulatory affairs teams, and other internal relevant functions. Strong experience and working relationships across FDA and PhRMA highly desirable required - 1 or more years experience working with international teams; strong understanding of cross-cultural environments and different business practices across key markets preferred - 1 or more years experience of working with the global regulatory landscape for at least 2 of the following: Oncology drugs, Biologics/ADCs Companion diagnostics preferred 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: $189,520.00 - $284,280.00 Download Our Benefits Summary PDF

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. Responsibilities and Accountabilities: Strategic Statistical Leadership Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. Lead development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Cross-Functional Quantitative Team Leadership Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: Clinical trial biostatisticians Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) Medical Affairs statisticians Statistical programmers Biomarker/statistical genetics experts in oncology RWE analysts/statistical epidemiologists Safety/PV statisticians Advanced analytics and modeling specialists Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological Excellence Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. Mentorship and Capability Development Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. Share knowledge and best practices across study teams and therapeutic areas. Contribute to internal training, methodology development, and talent pipeline initiatives. Governance and Cross-Functional Influence Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks.

Otsuka America Pharmaceutical Inc. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In its evolved customer engagement model, a Hospital Specialist engages healthcare providers (HCPs) using in-person, virtual, and digital tools, offering expertise on products and their approved conditions. This model enhances patient, caregiver, and HCP experiences by focusing on local care delivery, aiming to improve patient care and provide a superior experience. The "ecosystem approach" unifies account management, medical, patient access, and market access teams to engage with local healthcare systems, identifying opportunities to enhance the patient experience. This matrix model ensures coordinated and seamless care, supported by digital tools to bridge care gaps. These ecosystems are led by Area Business Leads and are organized into regional areas. Area Business Leads have significant autonomy to assess unique market priorities and tailor decisions to meet local customer needs. In the future, Otsuka aims to enhance customer engagement quality, accountability, and cohesion between patients and healthcare providers, with a focus on customer-centricity. The Hospital Specialist will report directly to the respective Area Business Lead, coordinating with cross-functional colleagues in Medical, Market Access, and Patient Support under appropriate guidelines. This individual will serve as the primary point of contact for HCP customers and should possess a broad range of expertise, capable of addressing complex on-label information based on approved content. **Purpose** This position is designed to enhance customer engagement, thought leadership, and business planning within the organization. The role involves proactive outreach to healthcare professionals (HCPs), facilitating discussions, and elevating insights to inform strategic decisions. Below is a detailed overview of the key responsibilities and objectives associated with this position: **Key** **Responsibilities** + Conduct proactive outreach to HCPs on topics such as product access, on-label information, and established patient care guidance. + Engage customers through various virtual or digital tools and direct them to other colleagues (e.g., MSLs) as needed. + Facilitate speaker programs and organize local provider groups for discussions on experiences and outcomes with local/regional leaders. + Elevate opportunities and feedback to the Area Business Lead, including local market insights to inform local strategy and business goals. **Experience & Qualifications** + A minimum of 2 years of pharmaceutical or medical device sales experience. + Must reside within a commutable distance of 50 miles from the primary city in the sales territory. + Previous cross-functional industry experience in commercial life sciences or related industry. + 4 or more years of experience working in a sales role with HCPs, ideally representing multiple products. + Ability to work in an ambiguous environment undergoing transformation. + Proven track record in coaching, training, and mentoring peers or others. + Demonstrates a commitment to ethical business practices, an understanding of regulatory standards, and the ability to execute business activities in compliance with Company policies and guidance. + Ability to assimilate and communicate complex clinical and product information **Key Sales Capabilities** + **Territory Analysis / Business Planning** + Uses competitive data and business reports to track progress and uncover opportunities, including sales data and promotional budget + Displays knowledge of territory and business conditions that impact sales results to establish near term priorities for his/her territory business plan + Responds compliantly to competitive threats and opportunities + Educates office staff on payer guidelines and reimbursement procedures to increase pull through + Effectively utilizes promotional materials + **Selling Skills, Engagement & Account Pull Through** + Maintains ongoing awareness of internal support team resources available throughout the ecosystem and utilizes appropriately + Applies market and industry knowledge to overcome objections and influence prescribing habits during the total office call + Identifies territory professional groups to network and ensure access/exposure to potential key opinion leaders + Builds strong relationships with all key office/practice personnel and focuses on patient health in conversations with all staff members. Takes personal responsibility for follow-through and providing value to the accounts by providing accurate information in response to their needs + Delivers effective and balanced office calls and sales presentations utilizing the appropriate approved marketing materials and technical references (e.g. studies, package inserts, etc.) with clarity and confidence to help HCPs enhance patient outcomes; demonstrates competent product knowledge of own product and competition **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $112,800.00 - Maximum $162,150.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Study Physician (SP) is a critical role within Clinical Development Oncology (CD Onc) to establish readily available medical support and consultancy for clinical trials within CD Onc by a qualified and clinically experienced physician. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. **Duties & Responsibilities** + Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. + Responsible for medical input into CTP updates. + Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct. + Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP. + Responsible for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs. + Responsible for execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues. + Takes medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data. + Supports close to real time clinical data medical oversight by using advanced technologies and systems. + Proactively addresses/communicates clinical quality issues in a collaborative environment. + Contributes to the timely preparation of medically relevant core trial documents and timely milestones. + Responsible for medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing. + Responsible for "Information for CRF completion" (ICC), Data Review Plan (e.g., propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc. + Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc. + Responsible for medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report. + Contributes to the medical content of responses to questions from regulators and Ethic Committees/IRBs. + Responsible for medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans. + Responds to medical queries from Investigators, CROs and/or Sponsor team representatives and contributes to maintenance of trial FAQ log/list. + Builds network with experts and active contribution to site engagement. + Supports Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective. + Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff. + Responsible for medical review of and contribution to the content of Trial Newsletters. + Contributes to the scientific publication of trial data (If applicable). **Requirements** + Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of four (4) years of active clinical practice experience; specialization in internal medicine or general practice is desirable. MD in Oncology is preferred. + Experience specifically in Oncology Clinical Development is preferred. + Experience in pharma industry or CRO in medical or project management functions (ideally in Clinical Development) is desirable + Ability to communicate directly and concisely while collaborating with key stakeholders. + Pronounced analytical skills and systematic and well-structured working style. + Pronounced presentation and training skills. + Capability to work proactively and with team spirit in an international environment and team. + Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment. + Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken. **Eligibility Requirements** : + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. **Compensation** This position offers a base salary typically between $220,000 and $350,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits, please click here. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. **Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with a strong focus on North American requirements. + Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. **Policy & Advocacy:** + Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. + Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. **Cross-Functional Collaboration:** + Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. + Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. **External Engagement:** + Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. + Lead advocacy initiatives for innovative technologies and precedent-setting projects. **Operational Excellence:** + Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). + Ensure consistency and quality in dossier preparation across regions. **Expected Key Accountabilities from Global Regulatory Aspects** + Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. + Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. + Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. + Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. + Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. + Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. + Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. + Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. + Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. + Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. + Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility. **Required** + Advanced degree in Chemistry, Engineering or equivalent degree (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant exposure to North American regulatory requirements. + Proven track record in developing and implementing global CMC strategies and influencing regulatory policy. + Strong knowledge of FDA, ICH and global guidelines; prior experience in ICH initiatives highly desirable. + Expert technical and regulatory knowledge of the requirements for compliance with GMPs, GLPs, GCPs and an in-depth knowledge of global regulatory CMC submission requirements, with a strong understanding of the application of ICH and other guidance. + Exceptional communication and leadership skills; ability to influence internal and external stakeholders. + Experience representing companies in trade associations and industry forums. + Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope. + Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including oral and parenteral + dosage forms) is required. + Demonstrated track record for successful interactions with global health authorities related to CMC submissions. + Ability to navigate a global organization and to act globally and regionally as appropriate. + Excellent interpersonal, verbal and written communication skills with a demonstrated ability to resolve conflict situations and influence regulatory authorities, as well as internal and external stakeholders in high impact situations. + Proven leadership skills is preferred. **Salary Range** $170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Regulatory CMC Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Pharma Physician Development Program is a premier two-year rotational program designed to equip high-potential clinicians with critical insights into the pharmaceutical industry while fostering business acumen, leadership skills, and scientific expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key functions that drive product innovation and patient impact. Throughout the program, participants will receive in-depth training on the Product Development Lifecycle, develop essential leadership abilities, and gain valuable knowledge and experience working with cross functional teams to support Product Life Cycle Management. This experience is supported by mentorship and networking opportunities that create lasting foundations for career success in the pharmaceutical industry. **Responsibilities and Accountabilities:** Participants will contribute to Astellas programs across three key functional areas and gain a 360 degree view of drug development. This will require participation in 3 specialized rotations: 1. **Clinical Development (12 months)** + Collaborate as part of the leadership of the clinical team to support the definition of the clinical hypothesis, the clinical development plan (CDP) including Life Cycle Management (LCM) and execution of clinical programs. + Engage in clinical study design, preparation of essential clinical documents (e.g., Investigator Brochure, Protocols, Clinical Study Reports), and global health authority interactions. + Participate in medical monitoring, clinical safety and efficacy data review, and evidence generation strategy creation based on stage of product development. + Support clinical and program risk assessment and mitigation planning + Work cross-functionally on study-level activities (including operational readiness and execution required to deliver trials within timelines and budgets), stakeholder collaborations within matrix-based Asset Maximization teams to support efficient and timely decision making at governance discussions. 1. **Medical Affairs (6 months)** + Support the development and execution of regional growth strategies, planning the MA strategy aligned with LCM nd alignment of Global Brand Strategies. + Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review (MLR) and support internal training programs for field teams (e.g., MSLs and Sales Reps ). + Drive the design and execution of clinical and Real-World Evidence (RWE) studies, as well as HEOR initiatives for data generation advisory boards and external engagement for strategic insight collection, publication and congress planning, medical communications and medical education programs. + Embed agile ways of working while fostering collaboration across commercial and Medical teams. 1. **Pharmacovigilance (6 months)** + Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. + Develop an understanding of global pharmacovigilance regulations by engaging in activities such as signal management, aggregate reporting, and causality assessment in individual case safety reporting. + Develop an understanding of optimizing the benefit-risk profile of a product by participating in Safety Management Teams, Benefit Risk Teams and engaging in risk management planning and product label discussions. + Collaborate with teams on inspection readiness, QMS reviews and CAPAs. + Learn the fundamentals of relevant databases (e.g., LSLMV), dictionaries (e.g. MedDRA) and their use in both pre- and post-marketing safety surveillance. **Throughout the Program** + Participants will benefit from additional developmental opportunities, including: + Business Acumen Training: Gain specialized knowledge of Astellas' business processes, operational frameworks, and market dynamics. + Product Development Lifecycle Training: Develop a comprehensive understanding of the pharmaceutical innovation process, from concept to commercialization. + Leadership Skill Development: Build core leadership capabilities through mentorship, direct industry exposure, and structured training programs. + Cross-Functional Insights: Connect with and learn about relevant functions, including commercial, regulatory, and clinical teams, while engaging in collaborative decision-making processes. **Why Join the Program?** This program offers: + Mentorship: Receive guidance from experienced leaders across scientific, clinical, and business disciplines. + Leadership Development: Participate in curated experiences designed to build strategic leadership skills for success in the pharmaceutical industry. + Pharmaceutical Insight: Gain immersive exposure to Clinical Development, Medical Affairs, and Pharmacovigilance. + Cross-Functional Networking: Engage with professionals across global and diverse teams, fostering collaboration and networking opportunities. Embark on a transformative journey into the pharmaceutical industry that will position you as a future leader in clinical, medical, and scientific innovation. **Qualifications:** **Required** + Medical degree (MD or equivalent). + Clinical: 2 to 5 years of clinical experience, (including clinical fellowships and/or experience as an attending physician in clinical practice) preferably in oncology. + Scientific Research: Prior experience and interest in scientific (non-clinical or clinical) research would be an asset. + No pharmaceutical experience required **Key Skills:** + Strategic thinking, strong analytical, and problem-solving capabilities. + Excellent verbal and written communication skills, particularly in conveying scientific and clinical concepts to diverse global audiences. + Proven ability to work independently with a results-driven approach, as well as collaboratively within teams. + Professional fluency in English. + Highest level of scientific integrity and impeccable work ethic ( + Demonstrate Astellas Core Values: Commitment to Innovation, Integrity, and Impact. **Preferred:** + Published clinical or nonclinical research **Salary Range** $193,200 - $276,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Oncology Development Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

The Cardiovascular-Renal Sales Consultant is responsible for partnering in developing and implementing a plan for brand sales growth of BIPI and co-promoted cardio-renal-metabolic (CRM) products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The Cardiovascular-Renal Sales Consultant will conduct their business with key targeted healthcare providers (Cardiology specialists/Nephrology specialists/Advanced Practice Clinicians and Allied Healthcare Professionals). The consultant will have additional responsibilities for sales activities in teaching and community hospitals, federal and military hospitals, heart failure clinics, managed health care facilities, and integrated delivery networks, etc. utilizing in-person and/or digital/virtual platforms. The CR consultant is also responsible for generating advocacy for BI products with Key Decision Makers in the hospital accounts they are responsible for. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Leverages knowledge of cardiology, nephrology, diabetes, and the marketplace to anticipate and effectively manage business opportunities and challenges. Demonstrates knowledge of the disease state, key drivers, influencers, and prescribing patterns in territory. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Works effectively with all customer-facing roles (i.e.. account teams, medical teams, etc.) in each geography to meet customer needs and deliver net sales objectives. Demonstrates knowledge of BIPI cardio-renal-metabolic (CRM) products and related marketplace, effective translation of product knowledge into the sales presentation and is customer focused with a priority directed towards providing solutions-based customer interactions. Delivers high level of clinical and technical value to his/her customers, assisting the health care customer in meeting their unique patient care needs, all within BI regulatory guidelines. As a trusted CR Consultant, encourages and receives requests from customers for technical information outside of standard visits. Through all these endeavors, develops trust and subsequent value with customers. Drives appropriate utilization of approved Cardiovascular-Renal products. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. CR Consultant works closely with other commercial associates to generate pull-through within local payers, hospitals, community Health Care Providers. Fosters cardio-renal customer network development and communication. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. The CR consultant must demonstrate the ability to engage with customers through a variety of digital media and platforms (live, remote video conference, marketing email etc.) and integrate digital assets and strategies into broader territory-level business plans. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Supports the efforts in various care settings to include appropriate pull through of protocols, pathways, order sets, formularies, treatment algorithms, transition of care, and population health management initiatives to assist with the delivery of optimal care. Requirements This is a dual level posting. Candidates will be hired at the level commensurate with their experience and business need. Cardiovascular-Renal Sales Consultant Requirements: Bachelor's degree preferred. At least three (3) years of experience in pharmaceutical sales of which one-plus (1+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. Hospital and/or Account Management experience preferred. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Executive Cardiovascular-Renal Sales Consultant I Requirements: Bachelor's degree preferred. At least five (5) years of experience in pharmaceutical sales of which two-plus (2+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. At least one-plus (1+) Hospital and/or Account Management experience required. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Clinical Modeling, Analytics & Operational Excellence team is a high-impact innovation team that applies advanced analytics, real-world data, modeling & simulation, and AI/ML to solve critical challenges in clinical development. This team designs and implements predictive models for patient recruitment and retention, optimizes trial feasibility and site selection, assesses novel clinical endpoints, simulates study outcomes to guide protocol design, and develops innovative operational strategies to reduce execution risk and accelerate timelines. The Clinical Modeling & Analytics Innovation Scientist will shape the future of data-driven clinical development by pioneering innovative solutions at the intersection of AI/ML, advanced analytics, modeling and simulation. This position collaborates closely with colleagues across clinical, biostatistics, real-world data, clinical operations, and digital/IT to improve feasibility assessments, enhance enrollment forecast, deepen data exploration and optimize trial decision-makings. In addition, the Clinical Modeling & Analytics Innovation Scientist will be at the forefront of innovation, developing novel methodologies and driving adoption of emerging technologies (e.g., generative foundational models, digital twins, and advanced imaging analytics) to transform clinical trial strategy and execution. **Essential Job Responsibilities:** The Clinical Modeling & Analytics Innovation Scientist + Contributes to cross-functional initiatives by collaborating with cross-functional teams and applying clinical modeling & simulation, advanced analytics, and AI/ML to trial design, feasibility, and execution optimization. + Implements and delivers simulation and predictive models to inform and optimize clinical trial planning, protocol development, patient recruitment and retention across therapeutic areas. + Contributes to the development and maintenance of clinical modeling & data strategy and roadmap dedicated to specific business areas. + Collaborates with medical, biostatistics, real-world data, and operational teams to embed clinical modeling & analytics insights into protocol development, portfolio planning and decision-making + Stays current with emerging technologies, proposes and develops innovative modeling and analytics methodologies, and leads or contributes to internal training and external publications and presentations **Qualifications** **Required:** + Advanced degrees in Statistics/Biostatistics, Data Science, Artificial Intelligence, Machine Learning, Epidemiology, Computational Biology, Informatics, or related quantitative disciplines. + PhD with minimum 3+ years of experience or MS with minimum 6+ years of experience in pharma/biotech, CROs or healthcare settings. + Deep understanding of quantitative theories in statistical modeling, AI/ML and independent project experience from planning to delivery. + Strong hand-on skills with one or more programing languages (i.e., R, Python, Julia, SAS, SQL etc.) for data manipulation, analysis and visualization. + Familiar with various data sources (i.e., clinical trials, RWD), and relevant standards (CDISC, OMOP, CTMS etc.) in clinical development and operations **Preferred:** + Experience with development and deployment of generative AI solutions (i.e., LLMs or foundational models), digital twins or medical imaging analytics etc. + Track record of quantitative expertise in advanced analytics, modeling & simulation and AI/ML, i.e., with publications and presentations + Experience with MLOps and workflow development within cloud platforms (Azure, AWS, GCP etc.) + Exposure to multiple therapeutic areas (i.e., oncology, ophthalmology, rare disease etc) and therapeutic modalities (i.e., small molecules, antibodies, bispecific, ADCs or targeted protein degradation, cell & gene therapy, etc.). **Salary Range:** $122,500 - $192,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program **\#LI-SS** Category Quantitative Sciences & Evidence Generation Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Clinical Modeling, Analytics & Operational Excellence team is a high-impact innovation team that applies advanced analytics, real-world data, modeling & simulation, and AI/ML to solve critical challenges in clinical development. This team designs and implements predictive models for patient recruitment and retention, optimizes trial feasibility and site selection, assesses novel clinical endpoints, simulates study outcomes to guide protocol design, and develops innovative operational strategies to reduce execution risk and accelerate timelines. The Clinical Modeling & Analytics Solution Lead plays a pivotal role in architecting and developing clinical modeling and analytics platforms, transforming prototypes into production-ready solutions, and enabling self-service tools to meet the evolving needs of efficient clinical operation and optimal trial planning/design. This position will collaborate across the business to design and deliver innovative solutions that improve accessibility, scalability, and reliability of clinical trial insights. Responsibilities and Accountabilities: The Clinical Modeling & Analytics Solution Lead: * Architects scalable trial operational data and analytics solutions, ensuring reliability and adaptability to meet long-term analytical needs for clinical trial optimization * Develops user-friendly dashboards and analytics tools and platforms for operational and feasibility insights that support key stakeholders across clinical trial portfolio * Translates data modeling and analytics prototypes into production-ready systems, partners with IT and digital teams to automate data & analytics workflows that are accessible to both technical and non-technical users * Implements processes and pipelines for deploying, monitoring, and maintaining data, analytical, forecasting and simulation models at scale * Collaborates with stakeholders to refine and adapt solutions for operational use * Acts as a key point of contact of Clinical Modeling & Analytics team to collaborate internal technical teams (i.e., clinical data enablement, digital/IT teams etc.), and contributes to the assessment of internal/external solutions * Provides technical leadership and mentorship to junior team members and colleagues involved in clinical modeling data and analytics projects * Develops and implements rigorous data governance practices to maintain compliance, security, and scalability in analytics workflows

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders. Leads and/or coaches a team or individual team member of regulatory CMC professionals. The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability. Responsibilities and Accountabilities: Strategic Leadership: Define and implement global CMC regulatory strategies with a strong focus on North American requirements. Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU. Policy & Advocacy: Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts. Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams. Cross-Functional Collaboration: Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies. Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions. External Engagement: Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations. Lead advocacy initiatives for innovative technologies and precedent-setting projects. Operational Excellence: Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes). Ensure consistency and quality in dossier preparation across regions. Expected Key Accountabilities from Global Regulatory Aspects Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions. Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders. Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities. Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders. Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs. Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects. Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation. Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas. Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training. Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions. Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility.