Director, IT R&D and Quality Applications Amylyx Pharmaceuticals IncDirector, IT R&D and Quality ApplicationsCambridge, MARemote$206,000–$232,000 / yearAdditional responsibilities will include a range of activities within the information technology organization including project management, development, and maintaining procedures to ensure Amylyx has a stable, robust, and scalable set of applications to support the changing business needs and support. In this role you will lead the strategy, delivery, and lifecycle management of systems supporting Research, Clinical Development, Data Management, Biometrics, Regulatory, Pharmacovigilance, and Quality functions.
Senior Director, Pharmacokinetics, Dynamics, Metabolism and Bioanalysis, Protein Therapeutics Merck & Co IncSenior Director, Pharmacokinetics, Dynamics, Metabolism and Bioanalysis, Protein TherapeuticsBoston, MA$194,100–$305,600 / yearRequired Skills: ADME, Assay Development, Bioanalysis, Bioanalytical Assays, Bispecific Antibodies, Communication, Cross-Cultural Awareness, Drug Discovery Development, Drug Metabolism, Fast-Paced Environments, Immunology, Immunotherapy, Innovation, Ligand Binding Assay, Modeling Simulations, Monoclonal Antibodies, Oncology, People Leadership, Pharmacokinetics, PKPD Modeling, Protein Engineering, Results-Oriented, Scientific Leadership, Strategic Thinking, Therapeutic Proteins. The successful candidate will lead a group of principal investigators and subject matter experts and will be expected to collaborate cross-functionally with discovery biologics, nonclinical drug safety, translational medicine and therapeutic area colleagues to ensure robust program strategies from early discovery through to IND submission and beyond.
Director, Global Patient Advocacy Lead AstraZeneca PlcDirector, Global Patient Advocacy LeadBoston, MA$151,753–$227,630 / yearJoining Alexion means working where every day is driven by the needs of people living with rare and devastating diseases, where diverse perspectives are welcomed, different thinking is encouraged, kindness sits alongside ambition, and teams are empowered to innovate at pace while staying closely connected to the communities they serve. The Director, Patient Advocacy will be responsible for driving, building and enhancing strategic alliances with both disease-specific advocacy organizations and those that span across disease area umbrella groups, as well as other rare/ultra-rare disease-oriented organizations in response to patient needs to drive Alexion AstraZeneca Rare Disease global patient advocacy strategic goals.
Associate Director, Manufacturing Operations EyePoint IncAssociate Director, Manufacturing OperationsNorthbridge, MA$150,000–$190,207 / yearThe Associate Director serves as a key member of the Operations leadership team and partners closely with Quality, Engineering, Supply Chain, Regulatory, and Product Development functions to drive operational excellence, maintain inspection readiness, and support company growth objectives. The Associate Director, Manufacturing is responsible for the leadership, strategic planning, and operational execution of manufacturing activities supporting the production of GMP-regulated combination products.
Director, Analytics Systems Beacon Biosignals IncDirector, Analytics SystemsBoston, MAThe Analytics System Team is responsible for building and maintaining Beacon's Analytics Suite products that serve our Life Sciences and Diagnostic customers, developing tooling and pipelines that enable Beacon scientists to efficiently curate clinical trial data and perform rigorous scientific analyses, and enabling the scalable computation, organization, and tracking of novel biomarker features. Drive product direction and discovery for the Analytics Systems Team, establishing the processes, venues, and cross-functional connections that build deep product intuition across the team, and owning prioritization decisions that ensure the team is consistently working on the highest-impact problems for Beacon''s customers and business.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyBoston, MA$218,058–$327,087 / yearAccountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.
Senior Director, Thought Leader Liaison Lead Amylyx Pharmaceuticals IncSenior Director, Thought Leader Liaison LeadCambridge, MARemote$248,000–$279,000 / yearReporting into the Vice President, Marketing, the Senior Director, Thought Leader Liaison Lead is a highly visible National leadership role responsible for building and executing Amylyx's commercial thought leader engagement and regional marketing capability from the ground up. 12+ years of experience in pharmaceutical or biotechnology commercial roles, including significant experience in thought leader engagement, sales, or marketing leadership with a minimum of 5 years leading thought leader engagement activities, strategy, and field-based teams.
Regulatory Affairs Strategy Director AstraZeneca PlcRegulatory Affairs Strategy DirectorBoston, MA$186,232.80–$279,349.20 / yearCompetitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
Associate Director, Quantitative Systems Pharmacology GSK plcAssociate Director, Quantitative Systems PharmacologyWaltham, MA$151,500–$252,500 / yearAs an Associate Director of Quantitative Systems Pharmacology (QSP) Expert, you will develop and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas. This role requires a highly motivated individual to develop and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas.
Associate Regulatory Affairs Director AstraZeneca PlcAssociate Regulatory Affairs DirectorCambridge, MA$135,624.80–$203,437.20 / yearAs a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD provides regulatory expertise and guidance on the clinical development requirements, including procedural and documentation requirements to regulatory and cross-functional teams, working flexibly within and across regions to achieve business objectives.
Associate Director, Global Labeling Lead 3316 Takeda Development Center AmericasAssociate Director, Global Labeling LeadMassachusettsThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is: Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device. In close collaboration with the Takeda R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.
Senior Director, Patient Services Amylyx Pharmaceuticals IncSenior Director, Patient ServicesCambridge, MARemote$253,000–$285,000 / yearDefine the strategic framework, service offerings, operational workflows, and end‑to‑end experience for patients, caregivers, and providers, ensuring alignment with the current market access landscape across reimbursement, technology, and delivery models. As a key leader in the commercial organization, this individual will partner with colleagues across market access, sales, and marketing, as well as cross functionally, to ensure a seamless and high impact customer experience that helps people start and continue treatment.
Director of U.S. Access Marketing AstraZeneca PlcDirector of U.S. Access MarketingBoston, MA$194,126.40–$291,189.60 / yearThis role involves creating and refining access-related, customer-facing marketing materials supporting tactical plan in collaboration with matrix and cross functional partners such as brand marketing leads, HEOR, clinical, and account teams, across customers (payers, providers, channel/trade partners, specialty pharmacies (SPs)) that result in a positive customer experience. Additional responsibilities include managing budget and agency partners, conducting market research, collecting customer feedback from account teams and designing targeted marketing materials to address customer concerns and optimize access via omni channel.
Director, Scientific Data Insights DatavantDirector, Scientific Data InsightsBoston, MA$180,000–$200,000 / yearAdvising internal stakeholders on best datasets for therapeutic areas and analytic solutions; lead the effort to validate and assess datasets with key internal constituents, and determine key research questions that can be addressed by specific data sources. The estimated base salary range (not including variable pay) for this role is: $180,000—$200,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc.
Senior Director, Global Regulatory Lead – Oncology 3316 Takeda Development Center AmericasSenior Director, Global Regulatory Lead – OncologyBoston, MassachusettsAcceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Associate Director, Global Regulatory Lead, Oncology 3316 Takeda Development Center AmericasAssociate Director, Global Regulatory Lead, OncologyBoston, MassachusettsDemonstrate acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. As Associate Director, Global Regulatory Lead Oncology, you will define and lead global regulatory strategies for oncology programs, oversee major submissions, and guide cross-functional teams to bring breakthrough treatments to patients globally.
AIRx Director, Computational & AI Biologics Design Lead 3316 Takeda Development Center AmericasAIRx Director, Computational & AI Biologics Design LeadBoston, MassachusettsThis role drives in silico biologics design, applies generative AI and structure-informed methods to antibody and large-molecule programs, and connects Takeda’s internal AI/ML platform capabilities to the day-to-day decisions of a fast-moving drug-hunting team. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Director, Quantitative Clinical Pharmacology (QCP) Lead 3316 Takeda Development Center AmericasDirector, Quantitative Clinical Pharmacology (QCP) LeadBoston, MassachusettsThese scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team.
Director, Global Regulatory Labeling Strategy 3316 Takeda Development Center AmericasDirector, Global Regulatory Labeling StrategyMassachusettsRemoteConducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
Associate Director, Research Strategy Development 3316 Takeda Development Center AmericasAssociate Director, Research Strategy DevelopmentBoston, MassachusettsThe Associate Director, Research Strategy Development is a critical member of our Research Strategy Development team, advancing key initiatives and serving as strategic partner to Research leaders in reshaping how research is conceived, organized, and executed as Takeda embarks on the Labs of Tomorrow transformation journey. Monitors the external landscape for relevant developments in AI, data science, emerging scientific trends, and technology-enabled research models, translating insights into strategic implications for Research group strategy and Labs of Tomorrow transformation priorities.