251 Biopharmaceutical Leadership jobs in Boston.

Boston

• Skills: nonclinical safety programs, GLP, toxicology, safety assessments, regulatory submissions, CRO management, study design, FDA guidance, Good Laboratory Practices, data-driven decisions
• Experience: 8-10 years in toxicology, pharmacology, or related discipline
• Type: Full-time

Cambridge

• Skills: Clinical Development, in-vivo base editing, Metabolic Disorders, clinical trial design, medical monitoring, Good Clinical Practices (GCP), regulatory submissions, IND's, clinical pharmacology, collaboration with study investigators
• Experience: MD, DO or equivalent ex-US medical degree with 15+ years experience; Minimum of 4 years of Pharmaceutical/Biotech industry experience in clinical development and medical monitoring.

Cambridge

• Skills: medical writing, regulatory submissions, clinical data, cross-functional collaboration, document management, project management, regulatory compliance, Common Technical Document, quality control, standard operating procedures
• Experience: 7+ years of experience in medical/clinical/regulatory writing in the pharmaceutical/biotechnology/healthcare industry; 3+ years of regulatory document project management oversight/experience

Boston

• Skills: clinical data analysis, scientific writing, medical communications, market access, evidence development, publications, regulatory documents, healthcare, patient access, creative presentation skills
• Experience: Recent graduates in the sciences; those with experience in scientific research
• Type: Full-time, Permanent
• Salary: $70,000 to $73,000 per annum

Boston

• Skills: IP strategy, patent portfolio, in-house IP experience, trademark strategy, IP due diligence, competitive intelligence, transactional work, patent law, biological field, legal counsel
• Experience: At least 10 years of IP advisor experience (prosecution, opinion work, strategic development, transactional work) and at least 4 years of in-house IP experience

Cambridge

• Skills: immunology, autoimmune diseases, drug discovery, target validation, in vitro, in vivo, pharmacological models, assay execution, data analysis, CRO collaboration
• Experience: Ph.D. in Immunology, Biochemistry, Molecular Biology, or a related discipline with 5-7 years of industry experience, with a focus on autoimmune disease
• Type: Full-time

Cambridge

• Skills: Regulatory Affairs, FDA interactions, Drug development, Oncology programs, Regulatory submissions, Clinical trials, Team leadership, Biopharmaceutical industry, Companion Diagnostics, Regulatory strategy
• Experience: A minimum of 9 years of Regulatory Affairs experience in the biopharmaceutical industry with at least 3 years of Regulatory experience with oncology programs.
• Type: Full-time

Boston

• Skills: Nonclinical Safety, Toxicologic Pathology, small molecule drug development, Regulatory Affairs, toxicology assessments, GLP and non-GLP studies, safety pharmacology, consultants management, CRO partnerships, regulatory compliance
• Experience: 18+ years of industry experience in toxicologic pathology within biotech or pharmaceutical settings.
• Type: Full-time

Boston

• Skills: real world data, epidemiology, study design, analytic approaches, dissemination of findings, biopharmaceutical product life cycle, data analytic, research questions, subject matter expertise, prospective study designs

Boston

• Skills: Consultant, Business Consulting, Regulatory Affairs, Clinical Strategy, Quality and Safety, Pharmacovigilance, Project Management, Customer Stakeholders, Digital Innovation, R&D
• Type: Full-time

Cambridge

• Skills: preemptive health, biotechnology, research initiatives, therapeutics, clinical trials, team leadership, partnerships, entrepreneurship, digital health, stakeholder management
• Experience: At least 15+ years of experience in life sciences sector
• Type: Full-time

Woburn

• Skills: Embolization procedures, Product usage, Clinical guidance, Training programs, Presentations, Customer support, Clinical expertise, Sales collaboration, Regulatory compliance, Customer satisfaction

Cambridge

• Skills: drug discovery, clinical testing, gene therapy, Hematology, Immunology, therapeutic programs, research strategy, cell and gene therapy, CAR-T experience, scientific communication
• Experience: 15-20 years of drug discovery experience, with at least 5-7 years in Hematology/Hemoglobinopathies or Autoimmune/Inflammatory diseases or Immuno-Oncology
• Type: Full-time

Cambridge

• Skills: T cell-driven autoimmune diseases, pharmacology, siRNA, bioassays, biomarkers, animal models, mechanistic studies, collaboration, regulatory submissions, team leadership
• Experience: Ph.D. in Pharmacology, Immunology, Molecular/Cell Biology, or related field, with a minimum of 7 years of relevant experience. M.Sc. with a minimum of 10 years relevant experience, industry experience is required.
• Type: Full-Time

Cambridge

• Skills: pharmaceutical collaborations, licensing transactions, business development, M&A, strategic alliances, negotiations, risk management, compliance considerations, life sciences, biotech
• Experience: 12+ years of experience in life sciences transactions.

Chelmsford

• Skills: Regulatory Affairs, medical devices, submissions, premarket notifications, EU MDR, risk management, compliance, project deliverables, audits, team collaboration
• Experience: 5+ years of Medical Device Regulatory Affairs experience
• Type: Contract

Cambridge

• Skills: regulatory strategies, compliance, medical devices, global regulatory oversight, product lifecycle management, cross-functional collaboration, regulatory submissions, health authority interactions, risk management, team leadership
• Experience: Minimum of 12 years of industry experience in Medical Device and Combination Products Regulatory Affairs, including 8 years leading Global Regulatory Affairs teams.
• Type: Full-time
• Salary: $184,000-$253,000

Boston

• Skills: clinical trials, oncology, project management, vendor management, GCP/ICH, clinical research operations, timelines, metrics, team collaboration, budget management
• Experience: 12 years in clinical research operations, with at least 2 years of oncology experience required, 5+ years preferred.

Boston

• Skills: product management, genomic applications, rare diseases, diagnostics, healthcare, hereditary cancer, pharmacogenomics, cross-functional collaboration, market analysis, stakeholder engagement
• Experience: 5+ years of product management experience, preferably in diagnostics or healthcare.
• Type: Full-time

Boston

• Skills: biostatistics, statistical work, regulatory strategy, CRO partnership, clinical studies, project management, programming in R, SAS, communication skills, decision support
• Experience: MSc/PhD in Statistics, Mathematics or recognized equivalent to stats MSc

Boston

• Skills: analytical method development, biologics, quality control, gene therapy, GMP, ICH guidelines, method qualification, team leadership, regulatory compliance, scientific writing
• Experience: 10+ years of industry experience in Quality Control and/or Analytical Development.

Boston

• Skills: biologics, antibodies, therapeutics, pharmaceutical, cross-functional teams, in vitro assays, mentorship, IND preparation, disease biology, cell-specific targeting
• Experience: 8+ years direct pharmaceutical experience.
• Type: Full-time

Boston

• Skills: data management, clinical data management, project management, negotiations, quality management, financial tracking, process improvements, Good Clinical Practices, regulatory guidelines, compliance
• Experience: 5 years direct Data Management experience, including 3 or more years as a CDM project lead.
• Type: Full time
• Salary: $82,300.00 - $173,900.00

Cambridge

• Skills: Precision Medicine, Biomarker Strategies, Oncology Portfolio, Clinical Development, Team Leadership, Cross-Functional Collaboration, Drug Development, Stakeholder Communication, Research Collaboration, Patient Stratification
• Experience: 12+ years in pharmaceutical or biotech industry, minimum of 5 years in oncology clinical drug development
• Type: Contract
• Salary: $233,700.00 - $389,500.00

Cambridge

• Skills: leadership, clinical operations, clinical trial, obesity, metabolism, global management, cross-functional, strategic direction, project management, GCP
• Experience: 15+ years of clinical operations experience
• Type: Contract
• Salary: $281,400.00 - $468,900.00

Cambridge

• Skills: Regulatory Affairs, Cell Medicine, Regulatory CMC, IND submissions, BLA submissions, FDA, global regulatory requirements, clinical development, health authority engagement, Cell & Gene Therapy
• Experience: 15+ years in pharmaceutical or biotech industry with a minimum of 10 years in Regulatory Science CMC for biologics or 4+ years in Cell & Gene Therapy / ATMPs.
• Type: Contract
• Salary: $251,200.00 - $418,600.00

Cambridge

• Skills: Pharmacometrics, PK/PD, modeling, simulation, quantitative drug development, leadership, strategic analysis, mentoring, collaborative skills, multi-disciplinary project teams
• Experience: 10+ years of industry experience (with a Ph.D.) or 12+ years (with an M.S.)
• Type: Contract
• Salary: $238,400.00 - $397,300.00

Newton

• Skills: Legal, Attorney, Counsel, Biopharmaceutical, Clinical Research, Product Development, Regulatory Compliance, Intellectual Property, Contracts, Litigation
• Type: Full-time

Cambridge

• Skills: commercial strategy, marketing, medical, insights, forecasting, advocacy, launch plan, market growth, cross-functional team, business opportunities

Cambridge

• Skills: toxicology, safety assessments, study design, contract management, regulatory documents, collaborators, pharmacology, biologics, gene therapies, therapeutic areas
• Experience: 5+ years experience in preclinical/nonclinical safety, pharmacology, and/or biology experience in the pharmaceutical/biotechnology industry
• Type: Hybrid

Boston

• Skills: Program Management, Drug Development, Project Management, Biotechnology, Collaboration, Clinical Trials, IND Preparation, Partnerships, Project Plans, Communication
• Experience: Program management experience for drug development programs in late nonclinical/early clinical phases, with proven track record of advancing candidates into the clinic.

Cambridge

• Skills: pharmacokinetics, pharmacodynamics, drug development, quantitative analysis, regulatory experience, interpersonal skills, scientific literature, communication skills, complex problem solving, pharmacology
• Experience: PhD +8 years in Quantitative Pharmacology or related field
• Type: Contract
• Salary: $202,000.00 - $336,600.00

Cambridge

• Skills: biostatistics, bioanalytical methodology, clinical studies, statistical analysis, immunogenicity, pharmacokinetic assays, study design, data visualization, regulatory submissions, statistical methodologies
• Experience: Minimum of 3 years of relevant experience for PhD or Master's degree
• Type: Full-time

Cambridge

• Skills: Data Science, Digital Health, Project Management, Clinical Trials, Real World Data, AI/ML Modeling, Trial Design, Patient Representation, Protocol Optimization, Feasibility Analytics
• Type: Hybrid

Boston

• Skills: Patient Advocacy, regulatory, healthcare, clinical development, relationship-building, leadership, public health, strategic thinker, negotiation, interpersonal skills
• Experience: Minimum 5 years of experience in similar functions: Patient Advocacy, Public Affairs, Government Relations, Medical Affairs environment; minimum 3 years of experience in Patient Advocacy role within industry.

Cambridge

• Skills: Clinical Leader, Ophthalmology, Early Development, Clinical Development, Clinical Trials, Regulatory Compliance, Biomarkers, Drug Development, Health Authorities, Cross-Functional Teams
• Experience: MD (or equivalent) is required. Board certification in Ophthalmology is preferred. Experience working in a Matrix environment is required. Up to 20% annual travel (domestic and international) may be required.
• Type: Hybrid Work

Cambridge

• Skills: program management, drug development, strategic planning, operational plans, cross-functional teams, project milestones, project strategies, communication, stakeholders, transparency
• Type: Full-time

Boston

• Skills: epidemiology, pharmacoepidemiology, clinical development, patient safety, regulatory affairs, observational studies, data analysis, mentor, cross-functional teams, strategic planning
• Experience: PhD/DSc/DrPH in Epidemiology with at least 6 years industry experience in the pharmaceutical industry, biotechnology, or consulting environment, or MPH/MSc in Epidemiology with at least 10 years industry experience.

Cambridge

• Skills: regulatory submissions, submission management, cross-functional teams, NDA, MAA, submission planning, project management, quality standards, critical path activities, continuous improvement
• Type: Hybrid

Boston

• Skills: clinical trial, stakeholder management, CRO oversight, GCP, ICH guidelines, clinical trial methodology, budget management, risk management, cross-functional team, vendor management
• Experience: 8+ years
• Type: Full-time

Boston

• Skills: oligonucleotide therapeutics, biotech, drug discovery, asRNAs, siRNAs, protein engineering, screening, leadership, collaboration, therapeutics
• Experience: Minimum of 6 years post-PhD experience, including experience in biotech/pharma drug discovery and development.

Cambridge

• Skills: Regulatory Affairs, Consulting, Clinical, Remote, Associate, Senior, Device, Medical, Drug, Lead

Cambridge

• Skills: therapeutics, metabolic, inflammatory diseases, GPCR biology, biologics, strategic leadership, collaboration, cross-functional teams, scientific development, communication
• Experience: Minimum of 10+ years of experience in industry, including leadership roles within metabolic disease-focused programs.

Waltham

• Skills: clinical trial management, project management, GCP, regulatory requirements, risk management, vendor relationships, EDC systems, clinical research, timelines, budgets
• Experience: 5+ years of experience in clinical trial management or related clinical research positions
• Type: Full-time
• Salary: $126,000-$154,000

Boston

• Skills: clinical development, FDA-regulated treatments, digital therapeutics, clinical R&D strategy, operational excellence, automation, cross-functional leadership, real-world evidence, partnerships, biopharmaceuticals
• Experience: 15+ years of progressive clinical R&D leadership in biotech, pharma, or digital health.
• Type: Full-time
• Salary: $300,000 - $350,000

Waltham

• Skills: regulatory strategy, submissions, clinical development, regulatory guidance, health authority meetings, expedited programs, regulatory documents, compliance, CTD format, collaboration
• Experience: 5-8 years of experience in regulatory strategy

Boston

• Skills: business development, strategy, collaboration, market mapping, AI, portfolio management, strategic partnerships, pharmaceutical industry, clinical trials, drug development
• Experience: Significant experience in strategy, business development, M&A or investing.
• Type: Full-time
• Salary: $300,000 - $372,000 (NYC & Boston), $285,000 - $353,000 (eligible remote locations)

Waltham

• Skills: Clinical Quality Assurance, Compliance, GCP, GLP, Regulatory, Clinical Development, Quality Systems, Audit, Training, Pharma/Biotech
• Experience: A minimum of 6 years relevant GCP experience in pharma/biotech company
• Type: Full-time

Cambridge

• Skills: Clinical Trial Design, Clinical Trials, Phase I, Phase II, Medical Monitoring, Safety Oversight, Regulatory Requirements, Compliance, Clinical Strategy, Cross-functional Team
• Experience: A minimum of 6 years of industry experience in clinical development in a pharmaceutical or biotech company setting.
• Type: Full-time
• Salary: $335,000 - 375,000

Cambridge

• Skills: preclinical research, drug development, pharmaceutical, biotechnology, neurodegenerative diseases, IND-enabling studies, clinical operations, regulatory submissions, collaboration, target identification
• Experience: 10+ years' experience in a pharmaceutical or biotechnology environment, including hands-on experience in scientific research activities in early drug development

Boston

• Skills: clinical development, oncology studies, drug discovery, clinical research, medical monitor, regulatory deliverables, precision oncology, team leadership, strategic execution, data analysis
• Experience: Minimum of 3 years of relevant experience in drug development either in industry (preferred) or in academia.
• Type: Full-time
• Salary: $318,000 to $364,000

Boston

• Skills: Medical Science Liaison, Oncology, scientific presentations, Key Opinion Leaders, Healthcare Providers, clinical trials, scientific resource, collaboration, research initiatives, genetic testing
• Experience: MSL experience preferred, but not required
• Salary: $143,700 - $170,000 USD

Boston

• Skills: clinical studies, CRO management, Informed Consent Form, project leadership, timelines, budgets, site management, quality assurance, clinical trial communications, CNS therapeutic experience
• Experience: Minimum 4+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
• Type: Hybrid

Cambridge

• Skills: DMPK, ADME, bioanalysis, immunogenicity, biologics, drug discovery, preclinical, bioanalysis, team collaboration, project leadership
• Experience: 5+ years of relevant industry experience with a Ph.D. or 10+ years with an MS/BS.

Cambridge

• Skills: regulatory strategy, global regulatory strategies, clinical-stage assets, oncology, autoimmune disease, regulatory authorities, registration strategies, product development, integrated regulatory ideas, therapeutic solutions