Associate Director jobs at Daiichi Sankyo - 1589 jobs

Senior Director, US Oncology Medical Affairs, Diagnostics
Daiichi Sankyo Company, Limited 4.8
Associate director job at Daiichi Sankyo
Senior Director, US Oncology Medical Affairs, Diagnostics page is loaded## Senior Director, US Oncology Medical Affairs, Diagnosticsremote type: Hybrid Work Arrangementlocations: Basking Ridge, NJtime type: Full timeposted on: Posted Yesterdayjob requisition id: R4630**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**Medical Affairs Diagnostic lead, under leadership of the Executive Director of Research and Strategy, US Oncology Medical Affairs. Develops and implements the USMA diagnostic strategy and tactical plan for all therapeutic areas as part of the US Brand Strategic Plan and leads the execution of the activities in the USMA plan including Launch Readiness and Life Cycle Management. **Responsibilities*** Responsible for the development of the US Medical Affairs strategy and medical objectives for all compounds and leads development, execution of the US Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective.* Participates in Global Medical Affairs committees as requested and processes as US Medical Affairs Lead, to gain strategic and planning alignment across the matrix team the core USMA functions. Represents US medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions.* Provides medical leadership:* Leads USMA teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE and HEOR strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the USMA Plan* Collaborates with Global Medical Affairs and across USMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data.* Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations.* Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively.* Provides input into publication strategy, data gap analysis, and tactical planning as part of the overall USMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents.* Manage budgets and resources efficiently for USOMA supported activities within the USMA plan, in collaboration with US Oncology Franchise Head**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)* Advanced scientific degree (Ph.D., PharmD or MD), equivalent will be considered with relevant experience in a health sciences related field or an equivalent combination of education and experience required* Bachelor's Degree required Experience Qualifications* 10 or more years pharmaceutical industry experience or commensurate healthcare or research experience required* 4 or more years Post-doctoral and/or relevant industry experience, and expertise in oncology biomarker and/or companion diagnostic development required* 4 or more years (in-house) medical affairs or related experience, US preferred required* Must have oncology experience, specifically in solid tumors* Previous overall responsibility and accountability for multiple indications of one or more compounds and related USOMA plan/budget for related MA activities •Demonstrated ability to lead and influence others internally and externally* Experience leading matrix medical teams and representing medical on cross-functional leadership teams (e.g. US Product Team, US Brand Team, Global Medical Team, etc.)* Relationships with or proven history developing key external experts* Proven ability to manage multiple priorities at one time* Strong knowledge of medical strategy, clinical diagnostic development, and Field Medical activities required* Knowledge of ADC or other biologics, or small molecules* Demonstrated experience working with an alliance partner company preferred**Travel Ability*** Must have the ability to travel up to 20%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:**$230,175.00 - $383,625.00At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc. #J-18808-Ljbffr
$230.2k-383.6k yearly 2d ago

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Senior Director, Cardio & Renal Statistics Lead
CSL Behring 4.6
King of Prussia, PA jobs
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional collaboration. Key Responsibilities Lead the Biostatistics function for the assigned Cardio and Renal Therapeutic Area (TA), with accountability for statistical deliverables across all stages of clinical development. Provide statistical thought leadership to Clinical Development teams in the design of clinical development plans, and clinical trials, ensuring robust methodology and alignment with program objectives. Partner with Therapeutic Area (TA) leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans (CDPs), target product profiles (TPPs), and regulatory submissions. Ensure high-quality statistical input into study protocols, analysis plans, clinical study reports, and regulatory documentation. Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA) and contribute to preparation of statistical content in submission dossiers. Champions the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks (e.g., Go/No-Go criteria, assurance). Collaborate with other functions (e.g., Epidemiology, Safety) on initiatives such as real-world evidence and patient safety analysis. Manage, develop, and mentor statisticians within the therapeutic area to build technical capabilities and ensure delivery excellence. Build relationships and oversee external vendors and CROs to ensure quality and compliance with timelines and standards. Contribute to departmental strategy, process improvement, and the advancement of statistical methodology and operations. Qualifications and Experience PhD in statistics or related field 10+ years of experience in clinical development within the pharmaceutical or biotechnology industry Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions Experience partnering with cross-functional teams and interacting with health authorities People management experience required; mentorship and team-building strongly preferred Experience managing external partners (CROs, consultants) Exposure to or leadership of statistical innovation initiatives preferred Competencies Strong statistical methodology knowledge and clinical trial design expertise Ability to collaborate and influence across functions and levels Excellent communication and interpersonal skills Experience with CDISC standards, programming oversight, and statistical operations Strategic and analytical mindset with a focus on execution Ability to work in a matrixed environment and lead through influence About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$122k-180k yearly est. Auto-Apply 3d ago
Senior Director, Project Mgt Office
CSL Behring 4.6
King of Prussia, PA jobs
Lead the Project Management Office for R&D Main Responsibilities & Accountabilities ••Leads PM office which will elevate the craft of all Project Managers in RD by steadily training the best personal practices, tools and methods to an end-to-end community of PM•Challenges the broader organization to be more project centric through outside in thinking, proposing process/culture/governance changes as part of the PPE group.•Provides direct management oversight of PMO group, China PM team (2), Submission PM (4 FTE + FSP) and dotted line reporting for Japan PM (4 FTE); through this ensures that all projects get consistent specialty support from these groups, and that their practices and resources meet the needs of the R&D portfolio.•Provides and trains R&D Project Managers in fit for purpose Tools, Templates and PM learning function that enable RD& projects to be planned in a consistent manner, that meets the needs of the organization for risk management, budget, critical path / timelines and resourcing issues. Qualifications & Experience Requirements •12+ years in R&D project Management or operations•Expert, first-hand knowledge of PM best practices, tools, templates and training groups on these•Experience working in cross-functional R&D teams•In-depth knowledge in drug research, development and manufacturing processes of pharmaceuticals•An advanced degree in Science, Master of Business Administration (MBA), PMP certification, or equivalent is a plus.•Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.•Involvement in cross-functional, multicultural and international teams preferable.•Excellent communication skills (written, verbal, presentation) in English; experience adapting messaging to suit the intended audiences•Excellent Strategic Thinking skills•Significant experience in the application and utilization of portfolio management systems and software••About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$79k-116k yearly est. Auto-Apply 1d ago
Director, Epidemiology
CSL Behring 4.6
King of Prussia, PA jobs
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director, Epidemiology? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three days onsite. Responsibilities: • As the epidemiology lead for designated products proactively define epidemiology research strategies to contribute to R&D and Commercial objectives. • Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports. • Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Update Reports, responses to Health Authority questions and requests). • Lead structured benefit-risk assessments, using qualitative and quantitative methods. • Contribute strategic and technical expertise in advancing the generation and utilization of RWE across the company. • Assist the head of department to facilitate ongoing development and growth of the department. • Actively contribute to CSL organizational efforts and initiatives to develop, communicate, and implement best practices, SOPs, templates, work instructions, etc. Qualifications: • Doctoral degree in Epidemiology or related quantitative discipline with at least 10 years of relevant experience (preferably in the pharmaceutical industry); or Master's degree in Epidemiology with at least 12 years of relevant experience in the pharmaceutical industry. • Demonstrated experience in identifying value of epidemiologic evidence across the lifecycle of assigned products. Ability to proactively advise and lead product teams in this regard. • Sustained autonomous performance as epidemiology lead to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple projects with regulatory/methodologic complexity. • Experience leading cross-functional teams in a matrix organizational structure is required, ideally at a pharmaceutical industry setting. • Demonstrated experience leading organizational process improvement or change management initiatives. • Demonstrated knowledge and application of that knowledge of the big picture of the business (i.e., not only the role of Epidemiology) including R&D and Commercial development activities. #LI-HYBRID About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.
$56k-110k yearly est. Auto-Apply 3d ago
Associate Director, Rare Disease Patient Services (Hybrid)
Astrazeneca 4.6
Boston, MA jobs
A leading global biopharmaceutical company is seeking an Associate Director for Patient Services Strategy in Rare Hematology/Nephrology in Boston, MA. This role will drive key initiatives for patient support programs, focusing on enhancing patient access and experience. Desired candidates will have a B.A./B.S. degree, at least 5 years in the healthcare industry, and strong project management skills. The position offers competitive pay ranging from $151,081.60 to $226,622.40 annually along with various benefits and incentives. #J-18808-Ljbffr
$151.1k-226.6k yearly 1d ago
Associate Director, Clinical Regulatory Writing - Hybrid
Astrazeneca 4.6
Boston, MA jobs
A global biopharmaceutical company is seeking a Clinical Regulatory Writing Manager (Associate Director) in Boston for a hybrid role. You will manage clinical regulatory writing activities and author critical documents to support drug development. Ideal candidates have a BS in Life Sciences and extensive medical writing experience in the pharmaceutical field. This position offers a competitive salary and comprehensive benefits, requiring a minimum of 3 days onsite weekly. #J-18808-Ljbffr
$139k-183k yearly est. 4d ago
Associate Director, Field Access & Reimbursement - West
Eisai Us 4.8
San Francisco, CA jobs
A leading pharmaceutical company is seeking an Associate Director, Access & Reimbursement in San Francisco. This field-based role involves leading the access and reimbursement team, ensuring patient access to products, and collaborating with various stakeholders across the healthcare landscape. Candidates should possess significant experience in healthcare reimbursement and access trends, ideally with a background in neurology and oncology. The position offers a salary range of $191,800 to $251,800, alongside benefits and incentives. #J-18808-Ljbffr
$191.8k-251.8k yearly 4d ago
Associate Director, Clinical Supply Chain - Radiopharma
Astrazeneca 4.6
Boston, MA jobs
A clinical-stage oncology company based in Boston is seeking an Associate Director of Clinical Supply Chain. The candidate will lead supply chain operations for specialized therapies, ensuring seamless delivery to clinical sites. Responsibilities include developing global supply strategies, maintaining supply plans, and mentoring a high-performing team. Candidates should have at least 7 years of supply chain experience, ideally in pharmaceuticals, and possess strong leadership skills. The role follows a hybrid schedule. #J-18808-Ljbffr
$139k-183k yearly est. 1d ago
Associate Director, Supply Chain
Astrazeneca 4.6
Boston, MA jobs
Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next‑generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle‑emitting isotopes to various targeting molecules to selectively deliver the alpha‑emitting payloads to tumors. Fusion's clinical portfolio includes: FPI‑2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI‑1434 targeting insulin‑like growth factor 1 receptor currently in a Phase 1 trial; and FPI‑2068, a bispecific IgG‑based EGFR‑cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRIs) and immune‑oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state‑of‑the‑art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs. We are seeking a highly skilled and experienced Associate Director of Clinical Supply Chain to lead and optimize our supply chain operations. The ideal candidate will have a deep understanding of the complexities involved in the production, storage, and distribution of these specialized therapies, ensuring seamless delivery to clinical sites and patients. Experience in cell therapy or radiopharmaceutical products is required. This position is based out of our Boston, MA office and will follow a hybrid work schedule. Responsibilities Develop and implement a comprehensive global supply chain strategy including robust contingency plans for investigational medicinal products to support Fusion medicinal assets and studies including radiopharmaceutical products. Ensure transparency with key stakeholders to ensure efficiency and delivery of uninterrupted IMP to patients. Generate and maintain a clinical and/or commercial supply plan to drive manufacturing, labeling, and forecasting logistic supply activities across internal and external stakeholders. Create strong relationships with key stakeholders through collaboration with cross-functional teams, including client and internal Clinical Operations, CMC, manufacturing, quality assurance, and regulatory affairs, to align supply chain activities. Design and implement processes and policies to enable inspection readiness for the management of clinical supply chain activities. Implement systems or processes based on a fit for purpose model to ensure integrity and quality of IMP. Lead implementation, standardization, and continuous improvement of clinical supply chain systems and processes, including validation, user acceptance testing, and documentation to ensure compliance and scalability. Oversee the selection and management of third‑party vendors from IMP management to systems. Act as a conduit between functions pertaining to supply, transportation, logistics, and traceability issues for IMP. Work with colleagues and vendors to identify and procure ancillary, comparator and companion drugs to support studies. Build and mentor a high-performing clinical supply chain team, fostering a culture of collaboration, innovation, and operational excellence. Understands the processes, technology and services the study team relies on, their needs and pain points. Using this knowledge to supply advice and guidance, removes barriers, supplies solutions and finds opportunities for improvement. Ensure timely and accurate financial reporting and forecasting related to clinical supplies. Serve as Business Owner for IRT, Labeling and forecasting, planning & inventory platforms, ERP; governing process design, data standards, integration, validation, and change control. Champion digital fluency and continuous improvement; mentor teams on systems, documentation, and governance. Qualifications Bachelor's degree in supply chain management, Business Administration, Life Sciences, or a related field; advanced degree preferred. High level of business process, technology and Clinical Study information knowledge Minimum of 7 years of experience in supply chain management, with at least 5 plus years in a leadership role within the pharmaceutical industry. IRT/XRS, Forecasting/Planning eSystems experience to design, implement and maintain systems used to automate clinical supply chain operations. Proven experience in complex advanced modalities (cell therapy, radiopharma, or biologics) preferred. Strong knowledge of regulatory requirements and industry standards for clinical supply chains. Excellent leadership, communication, negotiation skills, and the ability to work collaboratively with cross‑functional teams. Flexible in working hours to deal with global time zones as needed. Must be willing to step in and perform all aspects of the clinical supply chain core functions when needed to ensure successfully support of patient dosing. Have a sense of urgency and be comfortable pulling together stakeholders to make quick decisions as needed. 10‑15% travel as needed. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran. The annual base pay for this position ranges from $115,748 to $173,623.20. Our positions offer eligibility for various incentives-including short‑term incentive bonuses, equity‑based awards for salaried roles, and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr
$115.7k-173.6k yearly 1d ago
Associate Director Regulatory Affairs
EPM Scientific 3.9
Boston, MA jobs
Title: Associate Director of Regulatory Strategy A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented Associate Director of Regulatory Strategy. This role will lead regulatory strategy for drug-device combination product development. Key Responsibilities Serve as the global regulatory lead for assigned development programs and marketed products, with primary ownership of drug-device combination product strategy and a collaborative role in clinical and nonclinical planning. Prepare and represent the company in FDA and global Health Authority meetings (Type A/B/C, INTERACT, Scientific Advice), with particular focus on CMC, clinical, and combination product matters. Lead regulatory planning, authoring, and review of INDs, NDAs, BLAs, supplements, and briefing documents-ensuring strategic alignment and technical rigor. Provide strategic regulatory leadership across drug substance, drug product, device components, manufacturing processes, and packaging/labeling-particularly for injectable and inhalation drug-device combinations. This includes conducting change control impact assessments and preparing associated regulatory submissions to implement post-approval changes for marketed products in compliance with regulatory requirements. Partner with Technical Operations, Quality, Clinical, and Commercial functions to proactively identify and mitigate regulatory risks, support global change control processes, and provide strategic regulatory input to development and lifecycle management plans from early development through late-stage and post-commercialization activities. Contribute to internal regulatory policy, participate in industry forums, and engage with thought leaders to ensure the organization remains at the forefront of combination product innovation. Qualifications Bachelor's Degree in Life Science or Engineering with 12+ years of progressive regulatory experience, a Master's Degree with 8+ years, or a Ph.D. with 5+ years in biotech or pharma, with substantial responsibility for Regulatory across all stages of development. Experience with combination products (e.g., inhaled, injectable, or wearable systems) and an understanding of applicable FDA regulations and guidance (e.g., Human Factors, bridging strategies). Experience with global regulatory submissions (e.g., US FDA, EMA, Health Canada, PMDA). Familiarity with 505(b)(2) development strategies or innovative delivery platforms. Interest in mentoring or shaping regulatory frameworks in emerging therapeutic areas. Proven track record of successful interactions with the FDA and/or global regulatory agencies. Comfortable collaborating across disciplines to influence clinical development plans and contribute to integrated regulatory strategies. Strong writing, communication, and leadership skills-with the ability to translate complex issues into actionable strategies.
$112k-169k yearly est. 5d ago
Associate Director Pricing and Contracts
EPM Scientific 3.9
Boston, MA jobs
Associate Director, Contracts and Pricing Department: Market Access About Our Client Our client is a global leader in healthcare innovation, focused on improving patient access and delivering value through science and technology. They operate across prescription medicine, consumer health, and specialty care, driving growth through strategic partnerships and cutting-edge solutions. Job Summary The Associate Director, Contracts and Pricing - Prescription Business Unit (U.S.) will lead initiatives to develop, model, execute, and measure access and reimbursement strategies. This role ensures successful product launches, maximizes market adoption, and supports lifecycle management from early development through loss of exclusivity. Key Responsibilities Achieve financial targets: manage forecasts, invoices, accruals, and validation through budgeting and financial review processes. Oversee market access and reimbursement operations, including managed care contracting, payer negotiations, and rebate budgets. Lead Gross-to-Net modeling for portfolio and new launches; develop robust forecasts using contract data and insights. Collaborate with leadership and cross-functional teams to align on market access strategies and GTN assumptions. Serve as SME for payer negotiations; assess risks and opportunities to inform contract terms and conditions. Manage communication plans, KPI reporting, and compliance with healthcare regulations. Support business development and new product launches with market access assessments and go-to-market strategies. Qualifications Strong experience in market access, pricing, and contracting within the pharmaceutical or healthcare industry. Expertise in financial modeling, forecasting, and payer negotiations. Ability to manage complex projects and collaborate across functions. Excellent analytical, communication, and strategic thinking skills.
$112k-169k yearly est. 3d ago
Associate Director, External Partnering - Biotech Growth
Eli Lilly and Company 4.6
Boston, MA jobs
A global healthcare leader is seeking an experienced Associate Director in External Partnering to drive portfolio growth in molecule discovery and technology licensing. This strategic role involves expanding client relationships within the U.S. biotechnology sector. The ideal candidate will have a strong background in drug discovery and sales expertise. Key responsibilities include identifying new business opportunities and collaborating with scientific teams to develop optimized solutions. The position may allow for remote options and requires up to 30% travel. #J-18808-Ljbffr
$139k-180k yearly est. 3d ago
Associate Director, Accounting Transformation - Hybrid
Vertex Pharmaceuticals 4.6
Boston, MA jobs
A leading biotechnology company in Boston is seeking an Associate Director for Accounting Transformation. This role involves managing transformation projects, analyzing data, and collaborating with teams to improve accounting processes. Candidates should have substantial experience in finance or accounting within a large organization and be skilled in project management and communication. The position offers hybrid work options and comprehensive benefits. #J-18808-Ljbffr
$136k-177k yearly est. 4d ago
Associate Director, Compliance Partner (Hybrid)
Vertex Pharmaceuticals 4.6
Boston, MA jobs
A biopharmaceutical company is seeking an Associate Director, Compliance Business Partner to support compliance initiatives for its cell and gene, and kidney teams. This hybrid role involves advising on compliance strategies, conducting training, and maintaining knowledge of industry regulations. Candidates should have a law degree and 3-6 years of experience, demonstrating strong communication and project management skills. The position offers competitive pay and flexibility in a dynamic environment. #J-18808-Ljbffr
$136k-177k yearly est. 4d ago
Accounting Transformation Associate Director
Vertex Pharmaceuticals 4.6
Boston, MA jobs
Accounting Transformation Associate Director page is loaded## Accounting Transformation Associate Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27385**Job Description****General Summary:**Vertex is seeking a hands-on, experienced team member with a passion for transformation and bringing new capabilities to our organization. The Associate Director, Accounting Transformation will manage and support initiatives that will modernize, streamline, and enhance processes impacting the Accounting and Finance teams. This new role is ideal for a motivated individual who thrives on working on meaningful projects while bringing stakeholders along through all facets of the journey.**Key Duties and Responsibilities:*** Manage daily aspects of various transformation projects while keeping deliverables on track to meet agreed upon timelines.* Drive analysis of large data sets and provide clear interpretations as a result.* Engage with appropriate stakeholders to ensure reporting impacts are well understood, documented and addressed effectively.* Collaborate with cross-functional teams to analyze and document current and future state process workflows* Develop and execute strategy for testing system implementation and process updates, with a focus on transactional testing through reporting in a SOX compliant manner.* Partner closely with DTE, Accounting, Finance and other stakeholders, including any 3rd party vendors on gathering and finalizing requirements and cross functional resources needed* Implement best practices in financial reporting, internal controls, and compliance to ensure accuracy and consistency of accounting records* Assist with change management efforts to ensure the successful adoption of new systems, tools, and/or processes* Effectively communicate with and train stakeholders on any new tools or processes as needed**Knowledge and Skills:*** Demonstrated transformation experience with complex integrated transactional and reporting systems. Oracle EBS and Hyperion Essbase knowledge strongly preferred.* Understanding of accounting transactional system workflows and accounting principles.* Solid understanding of data movement into various reporting layers and hierarchies* Reporting enhancements including requirements gathering and functional design documents.* Possesses solid interpersonal and organizational skills with an understanding of Lean principles and project management terminology.* Able to anticipate change and leading by example with a “can do” attitude.* Excellent written and verbal communication skills including the ability to succinctly convey relevant information across multiple levels of the organization.* Strong understanding of internal controls and compliance requirements.* Knowledge of Tax and Treasury terminology a significant plus**Education and Experience:*** Bachelor's degree in either Accounting, Finance, Information Technology, Business or a related field* Typically requires 10+ years of experience in finance or accounting with a large, complex, multinational organization* Project experience leading and/or supporting transformational initiatives* Experience with transactional system design and testing* Life science industry experience is preferred* A track record of success working in a team-based environment* Experience with SmartView, RPA BOTS, and latest AI advancements is preferred#LI-HYBRID**Pay Range:**$0 - $0**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr
$136k-177k yearly est. 4d ago
Hybrid HCP Marketing Associate Director
Vertex Pharmaceuticals 4.6
Boston, MA jobs
A leading biotechnology company in Boston seeks an HCP Marketing Associate Director to develop and execute marketing strategies. The ideal candidate will have significant experience in pharmaceutical marketing, strategic planning, and strong analytical skills. Responsibilities include collaborating on brand strategies, overseeing agency partnerships, and measuring marketing effectiveness. A Bachelor's degree and at least 8 years of experience are required. This position offers a hybrid or on-site work model and a competitive salary range of $162,800 - $244,200. #J-18808-Ljbffr
$162.8k-244.2k yearly 2d ago
Associate Director, HCP Marketing - US Pain
Vertex Pharmaceuticals 4.6
Boston, MA jobs
HCP Marketing Associate Director page is loaded## HCP Marketing Associate Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27530**Job Description****General Summary:**The Marketing Associate Director is accountable for understanding the market landscape, defining and developing key business activities and tactics to support goals of the brand/portfolio, and measuring the success of those activities/tactics.**Key Duties and Responsibilities:*** Partners with brand/team-lead to help shape the brand strategy, segment the market, develop messaging and launch into new segments, including label expansions* Directs the development and implementation of strategic and tactical plans for assigned product* Collaborates with Vertex external communications review committee to approve materials for external use with customers* Generates and consolidates key insights across HCPs and patient stakeholders through market research, ad boards, etc.* Develops strong partnerships with cross-functional team to support business goals* Ensures appropriate metrics are in place to measure impact of tactics in field* Leads and manages agency partners to ensure on budget and timely deliverables* Acts as an advisor or coach to mentor other members of the team**Knowledge and Skills:*** Direct experience with communications review committee for review of tactics* Ability to oversee generation of insights and apply those insights to business problems/opportunities* Strong analytical mindset to lead others to solve complex problems* Demonstrated ability to develop strategy, make strategic recommendations, and monitor performance* Strong working knowledge of market forecasts and relationship of business drivers to revenue* Strong working knowledge of MS Office applications, including PPT, Excel and Word* Experience in pharmaceutical marketing or closely related field(s) (e.g., pharmaceutical sales, ad agency, etc.)**Education and Experience:*** Bachelor's degree in marketing, business, or scientific degree* Typically requires 8 years of experience or the equivalent combination of education and experience**Pay Range:**$162,800 - $244,200**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr
$162.8k-244.2k yearly 2d ago
Associate Director, HCP Marketing, Rare Disease
Ipsen 4.9
Cambridge, MA jobs
Ipsen's Rare Disease franchise has been expanding through both organic growth and acquisitions. From a marketing standpoint, there is a critical need for excellence in strategic planning and in execution to clearly define how we will best drive education of appropriate healthcare providers, deliver successful launches, and win in highly competitive spaces. The Associate Director, HCP Marketing, PBC is a key role on the Rare Disease Commercial Team and will report to the Iqirvo Brand Lead. The AD will support US marketing initiatives and key promotional activities to help the Rare team achieve near-term revenue goals and support the ongoing successful launch of Iqirvo. Responsibilities will encompass traditional HCP marketing including brand planning, development of materials and messages for multichannel engagement focused on congresses, advisory boards, peer to peer educational programs and KOL engagements. The role will include execution of both personal and non-personal promotional tactics. The AD will collaborate with the Thought Leader Engagement Team, Field leadership, Sales training, Medical Affairs, Legal & Business Ethics to execute tactics focused on HCP Marketing. Main Responsibilities & Job Expectations: Core Marketing Activities Lead key initiatives to implement tactical HCP Marketing plan Development & execution congress marketing plans & materials Speaker bureau content strategy, training, execution & ongoing management Advisory board planning and execution Amplify peer to peer messaging through multichannel engagement tactics Develop and monitor KPIs for brand tactical plan and communicate performance vs leading and lagging indicator to Rare disease leadership Contribute to Brand Planning and Tactical Plan development for Iqirvo Ensure compliant execution of all promotional activities Collaborate with: Rare disease field leadership to provide support with sales force execution and gain feedback and insights to adjust and enhance materials / messages Other brands teams within marketing to ensure cohesive delivery of portfolio strategy and unified external voice to customers Thought Leader Liaison team & Sales Leadership on marketing material development, execution and performance Promotional review committee to ensure compliant development of field resources in line with the strategy Business ethics & legal team to ensure compliant development and implementation of projects Cross Functional Collaboration & Stakeholder Management: Incorporate insights from primary and secondary research into development of field promotional tactics Share leadership responsibilities for regular cross-functional meetings including congress planning, bureau operations and brand team meetings Work with advanced analytics to ensure appropriate understanding and implementation of brand strategy. Knowledge, Abilities & Experience: BA/BS is required: PharmD or MBA preferred At least 10 years of experience in commercial pharmaceutical roles, with a minimum of 5 years in marketing Successful launch experience in the rare of specialty categories, hepatology would be a strong plus Excellent leadership, strategic planning, and project management skills Proven track record of developing and executing successful healthcare professional (HCP)marketing strategies Strong understanding of the rare disease landscape and patient needs Excellent communication and interpersonal skills along with the ability to influence others Ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously Strong analytical skills with the ability to interpret data and make informed decisions Knowledge of the AMA, ACCME, PhRMA and FDA regulations associated with promotion and industry-supported scientific education activities Able to work from our Cambridge, MA HQ on a hybrid model including 2-3 days in office Willingness to travel, including international, when needed The annual base salary range for this position is $151,500 to $222,000 This job is eligible to participate in our short-term incentives program. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
$151.5k-222k yearly 3d ago
Associate Director, HCP Kidney Marketing - US (Hybrid)
Vertex Pharmaceuticals (San Diego) LLC 4.6
Boston, MA jobs
A leading biotechnology company is looking for an HCP Marketing Associate Director to lead innovative marketing strategies for a new kidney therapy. The ideal candidate will have experience in specialty product launches and a proven track record in healthcare marketing. This role offers a hybrid work schedule, with options for remote work and extensive benefits including generous paid time off and educational assistance programs. Join a team dedicated to transforming patient lives through strategic marketing initiatives. #J-18808-Ljbffr
$119k-154k yearly est. 2d ago
Associate Director, Statistics
Allergan 4.8
San Francisco, CA jobs
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description TheAssociate Director, Statistics - Oncology provides statistical leadership for clinical development and life‑cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple disciplines to advance medicines to our patients. This role will work a hybrid schedule in one of the AbbVie locations: Lake County, IL South San Francisco, CA Responsibilities Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans. Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, and GMA, etc.) to create development strategies for assigned projects. Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately. Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians. Gain expertise in innovative statistical methods. Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff. Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators. Build external scientific connections which foster professional development and promote the reputation of the Statistics Department. Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements. Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required. Qualifications MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field. High degree of technical competence and excellent communication skills, both oral and written. Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others. Able to manage project timeline and quality of deliverables. Able to build strong relationship with peers and cross‑functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo. Have strong leadership skills and experience in working/managing cross‑cultural or overseas teams. Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life‑cycle management in the regulated environment. (SSG) Experience leading safety‑related projects (eg, ISS, benefit‑risk assessment, signal detection). (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies preferred. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short‑term incentive programs. This job is eligible to participate in our long‑term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* #J-18808-Ljbffr
$146k-190k yearly est. 3d ago