Biogen IncAssociate Medical Director, Global Drug Safety Biogen IncAssociate Medical Director, Global Drug SafetyCambridge, MA$194,000–$267,000 / yearRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. The Associate Medical Director, Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including: • review and analysis of safety data • design of clinical trials • identification and investigation of safety signals • management of benefit-risk profile for assigned compounds and products.
Monte Rosa Therapeutics, IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology) Monte Rosa Therapeutics, IncDirector, Drug Safety & Pharmacovigilance (Inflammation & Oncology)Boston, MassachusettsThis role is responsible for establishing and executing global safety strategy across early‑ and mid‑stage clinical programs, with particular focus on immune‑mediated toxicities, oncology risk management, and complex benefit–risk assessment. Overview: The Director of Drug Safety & Pharmacovigilance provides strategic and hands‑on leadership for pharmacovigilance activities supporting a clinical‑stage biotech pipeline in inflammatory and oncology diseases.
Careers Integrated ResourcesNewDrug Safety Associate Careers Integrated ResourcesDrug Safety AssociateCambridge, MAThe candidate will function as an integral part of the Global Case Management team, working under the direction of a manager, to meet department objectives or assist on special projects within established deadlines. The Safety and Benefit Risk, Global Case Management department performs pharmacovigilance activities, ensuring timely adverse event reporting in compliance with applicable laws and regulations/company policies throughout the lifecycle of products.
Nuvalent IncAssociate Director, Drug Safety and Pharmacovigilance Scientist Nuvalent IncAssociate Director, Drug Safety and Pharmacovigilance ScientistCambridge, MA$170,000–$195,000 / yearResponsibilities: Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports. The Role: Reporting to the Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports.
ALS TDIScientist I or II, In Vivo Pharmacology, Drug Discovery ALS TDIScientist I or II, In Vivo Pharmacology, Drug DiscoveryWatertown, MAThe ALS Therapy Development Institute (ALS TDI) is the world's leading nonprofit biotech focused exclusively on discovering and developing effective treatments for amyotrophic lateral sclerosis (ALS). This position is responsible for developing new animal models of ALS and performing preclinical pharmacology studies to evaluate the safety, efficacy, and mechanism of action of experimental drugs.
Deep OriginNewVP/SVP of Drug Discovery Deep OriginVP/SVP of Drug DiscoveryBoston, MAThis individual will serve as a key scientific and operational leader inside the company, partnering closely with computational scientists, experimental scientists (own lab), platform teams, translational biology, external collaborators, and executive leadership to prioritize programs, guide strategic decisions, and accelerate pipeline execution. This is a critical executive leadership role for a hands-on scientific leader who has spent significant time navigating the realities of drug discovery and development — someone who understands not only what can work scientifically, but what actually translates into successful therapeutic programs.
Centessa PharmaceuticalsNewVice President, Pharmacovigilance & Safety Centessa PharmaceuticalsVice President, Pharmacovigilance & SafetyBoston, MA$350,000–$380,000 / yearCentessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. The VP will drive an integrated, science-driven global safety strategy for the company's small molecule pipeline, working closely with internal stakeholders and teams, as well as global health authorities.
Ionis Pharmaceuticals IncAssociate Director/Director, Patient Safety Operations Ionis Pharmaceuticals IncAssociate Director/Director, Patient Safety OperationsBoston, MA$186,666–$251,068 / yearWith multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. This position plays a key lead role in overseeing the multidisciplinary arena of Patient Safety Operations (clinical development and post marketing), supporting the global pharmacovigilance systems and associated processes.
InterSystems CorpClinical Safety Specialist InterSystems CorpClinical Safety SpecialistBoston, MA$126,000–$163,000 / yearOur data platforms solve interoperability, speed, and scalability problems for large organizations around the globe to unlock the power of data and allow people to perceive data in imaginative ways. The Clinical Safety Specialist will work alongside other members of the clinical safety team to manage the adoption of InterSystems Clinical Safety Management Framework supporting the development and implementation of InterSystems products.
Parexel International CorpExecutive Director, Patient Safety Parexel International CorpExecutive Director, Patient SafetyMASkills: Excellent leadership and line management skills Excellent knowledge of drug safety and the drug development process Excellent knowledge of and ability to interpret and apply global safety regulations Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred Excellent team / project leadership and delegation skills Ability to train and mentor people Excellent presentation skills Excellent interpersonal skills Excellent time management skills Client focused approach to work Experience with Pharmacovigilance related computing systems Clinical Research or Pharmacovigilance knowledge /qualifications Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps Ability to comprehend various regulatory or client requests and be able to strategize a handling approach Flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies 7-10 years of management experience, including direct project management or program oversight Requires BA/BS degree or equivalent combination of education and experience or equivalent related degree and/or experience, plus significant executive and/or senior management experience, preferably in worldwide clinical research, pharmaceutical, or biotechnology company A strong background in Safety Operations execution is desirable Minimum of thirteen (13) years of related experience, including seven to ten (7-10) years of progressive management experience, including direct project management or program oversight. You will lead operational level planning with significant business oversight, drive 'positive change' throughout Parexel through continuous process improvement programs, as well as make significant contributions to the leadership of the Business Unit (BU) and the development of the strategy and direction of the BU.
Prime Medicine IncSenior Scientist, Safety Assessment Prime Medicine IncSenior Scientist, Safety AssessmentCambridge, MA$145,000–$177,000 / yearD. in toxicology or a related field with 6+ years of pharma/biotech experience in nonclinical safety assessment, or an M.S. in toxicology or a related field with 10+ years of experience in nonclinical safety assessment, the ability to work independently, provide domain expertise and leadership, as well as cross-functionally in a fast-paced, matrixed environment with a positive, flexible attitude. Position Overview We are seeking an enthusiastic, self-motivated Senior Scientist to join the Nonclinical Development group, supporting the nonclinical safety assessment function for IND-enabling programs across Prime Medicines pipeline.
Nova BiomedicalSr. Specialist, Environmental Health and Safety Nova BiomedicalSr. Specialist, Environmental Health and SafetyWaltham, MA$100,000–$130,000 / yearNova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences. This role partners closely with employees, leadership, and regulatory agencies to drive injury prevention, environmental compliance, employee training, and a strong safety culture aligned with current and future business needs.
Deciphera Pharmaceuticals IncMedical Director, Pharmacovigilance Deciphera Pharmaceuticals IncMedical Director, PharmacovigilanceWaltham, MA$228,000–$313,000 / yearThe Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility.
Rhythm PharmaceuticalsManager, Medical Information Rhythm PharmaceuticalsManager, Medical InformationBoston, MAFull timeMedical Information develops and disseminates Rhythm’s scientific/medical data through the provision of timely, accurate, and unbiased medical information responses to external parties (healthcare providers) or internal parties (affiliates and distributors) requesting medical or product information in the US and Globally. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
LancesoftDirector, Signal Management and Innovation LancesoftDirector, Signal Management and InnovationCambridge, MAGraduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or other relevant health-related field (MD, PhD, PharmD, NP, PA, pharmacy, or nursing degree) with at least 5 years of experience in clinical, pharmacological, or related fields of expertise. Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders.
Vericel CorpManager/Sr. Manager, Pharmacovigilance Operations Vericel CorpManager/Sr. Manager, Pharmacovigilance Operationsburlington, MA$109,000–$158,000 / yearOur commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).\u202f. Position Scope: Take a lead role in supporting oversight of pharmacovigilance operational and case management activities for safety data processing and reporting in accordance with all applicable regulations, guidelines with little or no supervision.
Ardelyx IncMedical Director, Pharmacovigilance Ardelyx IncMedical Director, PharmacovigilanceWaltham, MA$240,000–$320,000 / yearPosition Summary Medical Director, Pharmacovigilance (PV) leads product safety strategy, overseeing risk management, signal detection, and regulatory compliance from clinical development through post-market, serving as the medical safety expert, managing PV operations, guiding safety document authoring, and collaborating cross-functionally to ensure safe and effective product use. Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature for assessment of benefit-risk profile and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products.
Pride GlobalPharmacovigilance Specialist Pride GlobalPharmacovigilance SpecialistCambridge, MA$50–$60.23 / hourIndependently manage assigned cases, accounting for weekends and holidays, to deliver cases to internal stakeholders on time and ensure case completion allowing for on-time regulatory reporting. Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.
Keros TherapeuticsMedical Director Keros TherapeuticsMedical DirectorLexington, MA$248,000–$310,000 / yearWith a focus on developing differentiated product candidates that are designed to alter TGF- signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. A genuine interest in learning and understanding the science supporting the pipeline, an ability to work collaboratively in a highly matrixed multidisciplinary team setting, and a commitment to developing new treatments for patients in need are critical for success in this role.
AstraZeneca PlcGlobal Clinical Program Lead AstraZeneca PlcGlobal Clinical Program LeadBoston, MA$288,059–$432,088 / yearScientific and medical responsibilities include: • Study design concept delivery • Driving clinical and scientific decisions within Global Study Team • Accountable for clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice • Accountable for scientific medical input to all study documents to ensure consistency within clinical program and alignment with scientific rationale. Regulatory interactions: • Plays key role in development of the clinical sections of regulatory submission documents • Provides leadership in writing responses to comments/questions of Regulatory Authorities for clinical modules • Leads the strategy for the development of regulatory agency briefing documents and ensure completeness; may also defend positions during regulatory meetings.
BiogenNewAssociate Director, Pharmacovigilance Scientist BiogenAssociate Director, Pharmacovigilance ScientistCambridge, MA$172,000–$237,000 / yearRegular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. Oversee signal detection and management activities, Risk Management Plans (RMPs - core and EU), and aggregate reports such as Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Reports (PBRERs).
Intellia Therapeutics IncExecutive Medical Director, Clinical Development Intellia Therapeutics IncExecutive Medical Director, Clinical DevelopmentCambridge, MAYou will co-lead the cross-functional clinical development strategy subteam (CDST) for these therapies where your dual responsibility is to direct team decisions related to the short-term and long-term clinical development and provide medical input to the subteam efforts. • Advise the pre-clinical project teams as development candidates are brought forward to interpret pre-clinical data, identify biomarkers, define a target product profile, and plan for early phase trials.
LanceSoft IncMedical Reviewer LanceSoft IncMedical ReviewerCambridge, MA$110–$120 / hourFull timeSummary of Key Responsibilities: Perform daily medical review and causality assessment of ICSRs in accurate, consistent, and timely manner to contribute to continuous signal detection and management process Collaborate with other pharmacovigilance colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues Identify topics for escalation and collaborate with safety product leads to investigate potential safety signals Collaborate with GPSRM Quality and Case Management teams to identify case review issues and inconsistency and work on addressing these issues under the leadership of Head of Medical Review Participate in process improvements for the Medical Review team Maintain close communication with the case processing and medical case review vendors Qualifications: There is a strong pipeline, significant resources, and every intention of continuing the phenomenal rate of success and growth. The ideal candidate will have the following mix of personal and professional characteristics: Medical Degree with a minimum of 1 year of medical practice is required Must have a minimum of 2 years of pharmaceutical industry experience within pharmacovigilance or clinical research Experience in medical case review is a strong plus Sound clinical acumen and a wide range of therapeutic area knowledge.
Sumitomo Pharma America Holdings IncDirector, Clinical Research Sumitomo Pharma America Holdings IncDirector, Clinical ResearchMarlborough, MASumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, womens health, rare diseases, cell & gene therapies and CNS. Ownership of the key elements in planning and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues.
SanofiSenior Clinical Research Director, Rare SanofiSenior Clinical Research Director, RareCambridge, MA$225,000–$375,000 / yearBe the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other DMDs/DSDs/CSs, has the capacity to train them on the medical/scientific strategy by indication Key responsibilities include: Leading the clinical development plan strategies: Responsible for the clinical development plans and clinical sections of integrated development plans (IDP) Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Prepares Internal Governance documents and contributes to the medical aspects the TPP, TVP and other GPT documents related to one or several indications of the IDP in support of the GPH Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams Raise study or project-level issues to the project head and propose related corrective action plans Collaborates with external partners, regulators, scientific experts and internal stakeholders Provide operational expertise to project clinical sub team, as needed Evaluates relevant medical literature and status from competitive products Lead, Support and oversee the execution of clinical development and studies activities Collaborate and communicate appropriately with all function stakeholders (e.g. Main Responsibilities:The role of the Senior CRD is to: Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs Collaborate with other medical and clinical scientific experts CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g.
Boston Medical CenterMedication Adherence Program (MAP) Technician (Outpatient) Boston Medical CenterMedication Adherence Program (MAP) Technician (Outpatient)Boston, MAUnder the direct supervision of the Outpatient Mail Order Pharmacy Supervisor and Medication Adherence Packaging Pharmacist, the Medication Adherence Packaging (MAP) Technician, according to department policies and procedures, and guidelines, will work closely with providers, clinical pharmacists and the outpatient pharmacy department to provide a coordinated adherence packaged product for patients with complex medication regimens requiring additional support establishing and maintaining compliance to their medication therapies. The MAP Technician shall provide an unsurpassed patient experience by communicating to patients/providers program specifics/details and arranging for prescription processing/filling within the outpatient pharmacy with the ultimate goal is for patients to obtain an organized product they will understand allowing them to reduce or eliminate any adherence challenges.
Intellia Therapeutics IncMedical Director, ATTM-CM Intellia Therapeutics IncMedical Director, ATTM-CMCambridge, MAKnowledge and experience in gene editing/therapy is strongly preferred • Knowledge, training and experience in cardiology is preferred • Understanding of drug development process • Top level clinical and scientific expertise in relevant disease area • Professional demeanor & excellent interpersonal skills when dealing with external customers / internal colleagues • Ability to manage multiple tasks and deal effectively with deadlines • Creativity, resourcefulness, high energy and flexibility • Excellent verbal and written communication skills • MD • At least 5 years in industry, with the majority in key clinical development role #LI-Onsite. • Advise the pre-clinical project teams as development candidates are brought forward to interpret pre-clinical data, identify biomarkers, define a target product profile, and plan for early phase trials.
Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyWoburn, MADevelopment and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Bristol Myers SquibbSenior Clinical Trial Physician, Neuroscience Bristol Myers SquibbSenior Clinical Trial Physician, NeuroscienceCambridge Crossing, MA$308,700–$374,075 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets.
Bristol Myers SquibbSr. Clinical Trial Physician, Neuropsychiatry Bristol Myers SquibbSr. Clinical Trial Physician, NeuropsychiatryCambridge Crossing, MA$308,700–$374,075 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets.