Principal Scientist, Nonclinical Drug Safety Program Discovery Merck & Co IncPrincipal Scientist, Nonclinical Drug Safety Program DiscoveryWest Point, PA$176,200–$277,300 / yearThey are responsible for 1) providing risk assessments for targets, 2) de-risking strategies for discovery programs and 3) collaborating with NDS staff at other sites to execute on the appropriate studies to support selection of therapeutic targets, and the identification and development of new drug candidates. The Discovery Program Leader is responsible for defining and overseeing the NDS strategy for programs in all modalities (including small molecules, peptides, biologics and ADC programs) from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies.
Pharmacist Specialist - (Oncology - Investigational Drug Service (IDS University of Pittsburgh Medical CenterPharmacist Specialist - (Oncology - Investigational Drug Service (IDSPittsburgh, PAAs the preeminent institution in western Pennsylvania for the delivery of cancer care, the performance of basic, translational, and clinical research, and the education of the next generation of cancer researchers and physicians, UPMC Hillman Cancer Center is exceptionally well-positioned to contribute to the global effort to reduce the burden of cancer. Responsibilities: Interpret and evaluate physician orders and prescriptions to prepare, calculate, and dispense appropriate medication dosage forms for inpatient and outpatient treatment in accordance with the Pennsylvania Pharmacy Practice Act, Federal Drug Laws, and other regulatory organizations.
Oncology Clinical Pharmacist - Management Drug Therapy - Full-Time - Day WellSpan HealthOncology Clinical Pharmacist - Management Drug Therapy - Full-Time - DayYork, PAEssential Functions: Evaluates appropriateness of drug therapy for patients with specialty conditions referred to the WellSpan Management of Drug Therapy (MDT) Clinic (e.g., rheumatology, dermatology, endocrinology). Adjusts drug therapy and order laboratory tests or other diagnostic tests necessary in the management of drug therapy under Collaborative Practice Agreement (CPA) or written protocol in accordance with state law.
Quality R&D Operations Drug Substance Director GSK plcQuality R&D Operations Drug Substance DirectorKing of Prussia, PAWe need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people.
Small Molecule Drug Substance Lead GSK plcSmall Molecule Drug Substance LeadKing of Prussia, PAPlease note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
Pharmacist, Investigational Drug Services St. Luke's University Health NetworkPharmacist, Investigational Drug ServicesBethlehem, PAIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Planning and execution of study-specific blinding and unblinding plans for investigational products, ensuring compliance with protocol requirements, maintaining trial integrity, and coordinating with pharmacy and clinical teams to support blinded study operations.
Management Drug Therapy Coordinator - Full-Time - Day WellSpan HealthManagement Drug Therapy Coordinator - Full-Time - DayPAEssential Functions: Supports the Management Drug Therapy (MDT) Pharmacist with managing daily referral work queue, monitoring for new patient referrals, and collecting and documenting pre-visit information. Assists patients and providers with access to specialty medications through benefit verification, prior authorization, appeals, and patient assistance programs.
Clinical Psychologist (Drug Abuse Program Coordinator) U.S. Department of JusticeClinical Psychologist (Drug Abuse Program Coordinator)PA$89,508–$116,362 / yearIf you are on active duty and expect to be discharged or released from active duty service within 120 days, you may submit a Certificate of Release or Discharge from Active Duty from the appropriate Branch Personnel Office containing the following information: (1) the military service dates including the expected discharge or release date; (2) and the character of service (must be an honorable or general discharge); and (3) any qualifying service/campaign/expeditionary medals. The incumbent has professional autonomy in directing and supervising all clinical activities and staff in relation to the drug treatment of Bureau inmates, including: testing, test interpretation, clinical diagnosis, clinical staffing of inmates with staff and serving as the institution advocate for drug programs with all staff, including Executive staff.
Drug & Alcohol Prevention Specialist Child & Family Focus, Inc.Drug & Alcohol Prevention SpecialistBroomall, PAFull timeDeliver evidenced-based, youth-focused prevention programs including but not limited to LifeSkills Training (LST) (Elementary, Middle, High, and Transitions), The Blues Program, Too Good for Drugs (TGFD), Unity Circle, Girls Circle, and The Council for Boys and Young Men to participants in school, community, justice, and office-based settings when necessary. Deliver evidenced-based, caregiver- and family-focused prevention programs including but not limited to LifeSkills Training (LST) Parents and Strong African American Families (SAAF) to participants in school, community, justice, and office-based settings.
Principal Scientist, Drug Product Sterile Solutions GSK plcPrincipal Scientist, Drug Product Sterile SolutionsCollegeville, PAWe are seeking professionals with the following required skills and qualifications to help us achieve our goals: PhD in Pharmaceutics, Chemical Engineering, Biomedical Engineering, Chemistry, or related scientific discipline; or MS with 5+ years' relevant experience; or BS with 10+ years' relevant experience. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.
NewDrug and Alcohol Treatment Specialist 1 - SCI Forest Commonwealth of PennsylvaniaDrug and Alcohol Treatment Specialist 1 - SCI ForestForest County, PA$56,541–$86,022 / yearI have experience counseling patients in order to obtain their participation in planned rehabilitation programs; facilitating change in thinking and behavior by using motivational interviewing principles, cognitive behavioral therapy, rational emotive behavior therapy or motivational enhancement therapy as well as other methods; encouraging their participation in other facility provided programs and activities; conducting INDIVIDUAL AND GROUP therapy sessions; explaining available services; assisting patients in adjusting to their current living environment; and I have experience recommending community supports and programs to maintain recovery. I have experience counseling patients in order to obtain their participation in planned rehabilitation programs; facilitating change in thinking and behavior by using motivational interviewing principles, cognitive behavioral therapy, rational emotive behavior therapy or motivational enhancement therapy as well as other methods; encouraging their participation in other facility provided programs and activities; conducting INDIVIDUAL OR GROUP therapy sessions; explaining available services; assisting patients in adjusting to their current living environment; and I have experience recommending community supports and programs to maintain recovery.
Strategy Insights & Planning Consultant - R&D Drug Development Veeva ZS Associates IncStrategy Insights & Planning Consultant - R&D Drug Development VeevaPALeverage knowledge of R&D Products and Platforms (ex: Veeva, Medidata, IQVIA, etc.) to advise on strategic planning, functional data flow, product implementations (ex: configuration, deployment, migration, and GxP testing), R&D stakeholders & processes, and platform ecosystem management; Advise on R&D business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. In lieu of an MBA or PhD, 5-8 years of relevant work experience may substitute; Required: At least 2 years of direct product services/design/implementation/management experience with Veeva Vault Clinical or Veeva Vault Regulator product suites and data.
Director, Global Clinical Safety Madrigal PharmaceuticalsDirector, Global Clinical SafetyPennsylvaniaPosition Summary: Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the Director, Global Clinical Safety will play a key role in overall clinical safety strategy, safety assessment, evaluation and risk management of products in various stages of development as well as involvement in all safety surveillance activities and communication of regulatory safety topics for assigned products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Director. Global Clinical Safety Scientist Madrigal PharmaceuticalsDirector. Global Clinical Safety ScientistPennsylvaniaexcel files or Tables, Figures & Listings (TFLs)] including analysis and summary of key safety findings for internal Data Review Committees (DRCs), Data Monitoring Committee (DMC) meetings, and Clinical Study Reports (CSRs) (i.e. actual assessment of safety data). Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the Director, Global Clinical Safety Scientist will play a key role within Clinical Safety & Pharmacovigilance (CSPV) to develop and maintain safety assessments for all Madrigal clinical products in conjunction with the CSPV Physician and cross-functional team members.
Principal Scientist, Biostatistics, Clinical Safety Statistics Merck & Co IncPrincipal Scientist, Biostatistics, Clinical Safety StatisticsNorth Wales, PA$190,800–$300,300 / yearIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Required Skills: Biostatistics, Clinical Risk Management, Clinical Study Design, Clinical Trials, Clinical Trials Analysis, Data Management, Data Science, Numerical Analysis, Safety Management, Statistical Analysis, Statistical Software, Strategic Management, Strategic Planning.
Director, Global Clinical Safety Madrigal Pharmaceuticals IncDirector, Global Clinical SafetyConshohocken, PA$213,000–$260,000 / yearPosition Summary: Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the Director, Global Clinical Safety will play a key role in overall clinical safety strategy, safety assessment, evaluation and risk management of products in various stages of development as well as involvement in all safety surveillance activities and communication of regulatory safety topics for assigned products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Director/Sr. Director, Pharmacovigilance & Safety Ocugen IncDirector/Sr. Director, Pharmacovigilance & SafetyMalvern, PAThe incumbent provides medical leadership and operational accountability for the global PV system-ICSR management, signal detection, benefit-risk evaluation, aggregate safety reporting, vendor oversight, and inspection readiness-with particular focus on the distinct safety considerations of subretinal and intravitreal administration, AAV-related immunogenicity, and long-term follow-up under FDA CBER guidance. Develop and maintain program-specific safety surveillance strategies addressing the unique risk profile of ocular gene therapy, including intraocular inflammation (uveitis, vitritis, retinitis, endophthalmitis), chorioretinal atrophy, RPE changes, and procedure-related events from subretinal or suprachoroidal delivery.
Director. Global Clinical Safety Scientist Madrigal Pharmaceuticals IncDirector. Global Clinical Safety ScientistConshohocken, PA$213,000–$260,000 / yearexcel files or Tables, Figures & Listings (TFLs)] including analysis and summary of key safety findings for internal Data Review Committees (DRCs), Data Monitoring Committee (DMC) meetings, and Clinical Study Reports (CSRs) (i.e. actual assessment of safety data). Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the Director, Global Clinical Safety Scientist will play a key role within Clinical Safety & Pharmacovigilance (CSPV) to develop and maintain safety assessments for all Madrigal clinical products in conjunction with the CSPV Physician and cross-functional team members.
Director, Medical Safety Scientist Jazz Pharmaceuticals PlcDirector, Medical Safety ScientistPhiladelphia, PARemoteOther responsibilities include but are not limited to: signal management activities, production of aggregate safety reports (e.g., DSURs, PADERs, PBRERs), provision of high-level scientific expertise in the safety evaluation and risk management strategies of assigned products (e.g, signal evaluation reports, health hazard evaluations, and RMPs), global leadership / representation of Medical Safety within the company (e.g., leading Safety Management Teams, presenting at Executive Safety Board meetings), and SME support for HA inspections. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
Senior Director, Global Pharmacovigilance (Safety Physician) Immunocore Holdings PlcSenior Director, Global Pharmacovigilance (Safety Physician)Radnor, PAImmunocore NASDAQ IMCR is a pioneering commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines addressing unmet patient needs in oncology, infectious diseases, and autoimmune diseases. The role holder is a board-certified physician and recognized subject matter expert in pharmacovigilance with deep experience in biologic product safety signal detection, epidemiology, and regulatory benefit-risk decision making, e.g., FDA, EMA, and other Health Authorities.
Associate Principal Biostatistician Clinical Safety Statistics (CSS) Merck & Co IncAssociate Principal Biostatistician Clinical Safety Statistics (CSS)North Wales, PA$142,400–$224,100 / yearIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Required Skills: Clinical Development, Clinical Research, Clinical Safety, Clinical Study Design, Drug Development, Preclinical Research, Regulatory Compliance, Regulatory Documents, Regulatory Requirements, Safety Databases, Safety Evaluation, Scientific Modeling, Statistical Graphics, Statistical Research, Statistics, Vaccine Safety, Visual Analytics.
NewMedical Safety Officer - Solid Tumors Oncology Johnson & JohnsonMedical Safety Officer - Solid Tumors OncologyPA$199,000–$342,700 / yearThe Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight. Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
NewMedical Safety Officer, Immunology Johnson & JohnsonMedical Safety Officer, ImmunologyPAThe Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight. Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Scientist, Safety Pharmacology Merck & Co IncScientist, Safety PharmacologyWest Point, PA$87,300–$137,400 / yearThe Nonclinical Drug Safety (NDS) division at our company is seeking a motivated and talented biomedical engineer or integrative systems scientist with experience in signal processing and/or computational modeling using physiologic signals to join our Safety & Exploratory Pharmacology group. QUALIFICATIONS: Education: Bachelor's (with 3+ years) or Master's in Biomedical Engineering, Bioengineering, Computational Biology or related scientific field and relevant experience in the collection and computational analysis of physiologic signals (e.g.
Associate Medical Director, Medical Safety Jazz Pharmaceuticals PlcAssociate Medical Director, Medical SafetyPhiladelphia, PARemote$212,000–$318,000 / yearServe as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products. Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
Medical Director, Medical Safety Jazz Pharmaceuticals PlcMedical Director, Medical SafetyPhiladelphia, PARemote$256,000–$384,000 / yearSupport signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s.
Associate Director, Global Safety Lead - Remote Agios PharmaceuticalsAssociate Director, Global Safety Lead - RemotePhiladelphia, PARemote$185,369–$308,948 / yearo The current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. • Proactively assesses and evaluates the clinical implications of safety data from all sources in order to understand and communicate the benefit-risk profile of assigned drugs in development and in the post-marketing settings as appropriate.
Safety Associate - Full Time, Night - Jefferson Torresdale Thomas Jefferson UniversitySafety Associate - Full Time, Night - Jefferson TorresdalePAJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrows professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.
Analyst, Preclinical Compliance & Safety Johnson & JohnsonAnalyst, Preclinical Compliance & SafetySpring House, PARequired Skills: Preferred Skills: Agility Jumps, Analytical Reasoning, Business Behavior, Collaboration Tools, Cost-Benefit Analysis (CBA), Data Analysis, Execution Focus, Monitoring, Evaluation, and Learning (MEL), Process Oriented, Project Management Methodology (PMM), Project Management Office (PMO), Project Reporting, Project Support, Stakeholder Engagement, Statement of Work (SOW), Time Management. The team enables fit-for-purpose processes, tools, and ways of working, and partners closely with cross-functional team members to support a safe laboratory environment and ensure data are reconstructable, reliable, and able to withstand internal and external scrutiny.
NewMedical Safety Officer - Solid Tumors Oncology 6084-Janssen Research & Development Legal EntityMedical Safety Officer - Solid Tumors OncologyTitusville, PennsylvaniaThe Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight. • Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Medical Safety Officer, Immunology 6084-Janssen Research & Development Legal EntityMedical Safety Officer, ImmunologyTitusville, PennsylvaniaThe Medical Safety Officer (MSO) is a physician with training or experience in Medical Safety, who reports into the Global Medical Safety (GMS) organization and has accountability for assessing the medical safety of Innovative Medicine products and strategically leading cross-functional matrix teams responsible for product safety and benefit risk oversight. Work across the GMS TAs to align and improve common processes including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety-related processes and issues.
Safety Associate - Part Time, Rotating (Evening/Night) - Jefferson Frankford Thomas Jefferson UniversitySafety Associate - Part Time, Rotating (Evening/Night) - Jefferson FrankfordPhiladelphia, PAJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region.
Sr Director, Head of Data Science & Digital Health – Preclinical Sciences & Translational Safety (PSTS) Johnson & JohnsonSr Director, Head of Data Science & Digital Health – Preclinical Sciences & Translational Safety (PSTS)Spring House, PennsylvaniaWork with peers across Discovery, Product Development, & Supply (DPDS) and our Therapeutic Areas to generate and analyze our data in the best way possible for opportunities in translational safety and preclinical sciences (for example: experiment design, safety risk prediction, lab process automation, etc.). This role will partner closely with PSTS leadership, PSTS teams, and IT partners to advance translational safety, deliver robust data products, and scale advanced analytics and AI capabilities across the portfolio.
NewPharmacovigilance Specialist Integrated Resources, IncPharmacovigilance SpecialistPittsburgh, PAUnder the direct guidance and supervision of the Manager, Pharmacovigilance: Monitor and audit all potential sources of safety information including (but not limited to) recorded calls, claims, faxes, text messages, chat logs, and other records for the presence of Adverse Events and/or Product Quality Complaints. Must utilize problem-solving skills to resolve concerns independently, or escalate problems to Senior Specialists and the Manager when assistance or clarification is needed.
SERM Senior Scientific Director, Oncology GSK plcSERM Senior Scientific Director, OncologyCollegeville, PA$217,800–$363,000 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. As a senior leader within Global Safety, the Senior Scientific Director, Clinical Safety (Oncology) provides strategic scientific leadership and oversight of clinical safety and pharmacovigilance activities across assigned oncology assets.
Director, Clinical Development, Neuroscience Jazz Pharmaceuticals PlcDirector, Clinical Development, NeurosciencePhiladelphia, PARemote$196,000–$294,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company''s Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz''s Long Term Equity Incentive Plan. Collaborate closely within clinical development and with cross-functional team members including in clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of clinical trials and programs.
SERM Senior Medical Director GSK plcSERM Senior Medical DirectorCollegeville, PA$284,625–$474,375 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.
Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Madrigal PharmaceuticalsSenior Director, Product Quality Lead (Post-Marketing and PharmacovigilancePennsylvaniaAs a key member of the Quality leadership team, you will partner closely with Pharmacovigilance, Regulatory Affairs, Manufacturing, and Commercial teams to embed quality across the full product lifecycle, with particular focus on post-marketing safety surveillance, literature monitoring, and Product Quality Complaints (PQC). Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
NewGlobal Pharmacovigilance (PV) Senior Scientist Amgen IncGlobal Pharmacovigilance (PV) Senior ScientistPhiladelphia, PAIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Madrigal Pharmaceuticals IncSenior Director, Product Quality Lead (Post-Marketing and PharmacovigilancePA$244,000–$299,000 / yearAs a key member of the Quality leadership team, you will partner closely with Pharmacovigilance, Regulatory Affairs, Manufacturing, and Commercial teams to embed quality across the full product lifecycle, with particular focus on post-marketing safety surveillance, literature monitoring, and Product Quality Complaints (PQC). Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
Medical Director/Sr. Medical Director, Clinical Development Avalo TherapeuticsMedical Director/Sr. Medical Director, Clinical DevelopmentChesterbrook, PAThe Medical Director will be responsible for collaborating with clinical operations, regulatory, translational medicine/biomarkers, clinical pharmacology, CMC, and quality assurance functions; liaising with clinical investigators and site personnel; and establishing and building relationships with key external experts. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e-mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.
Associate Director, Medical Review Lead, MSRM - Remote Agios PharmaceuticalsAssociate Director, Medical Review Lead, MSRM - RemotePhiladelphia, PARemote$185,369–$308,948 / yearThe current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This role provides oversight of medical review for Individual Case Safety Reports (ICSRs) across investigational and marketed products, ensuring medical accuracy, regulatory compliance, and high-quality safety data to support pharmacovigilance and risk management activities.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesNorth Wales, PA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Director, REMS Strategy & Operations Cytokinetics IncDirector, REMS Strategy & OperationsRadnor, PA$220,500–$257,250 / yearCollaborate and work cross-functionally with all external vendors and internal stakeholders (i.e. Sales, Marketing, Market Access, Trade, Compliance, Commercial Operations, Legal, Drug Safety, Regulatory, and Quality) to support impactful strategies. Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
Principal Scientist/Lab Manager, Clinical Pathology Merck & Co IncPrincipal Scientist/Lab Manager, Clinical PathologyWest Point, PA$173,200–$272,600 / yearRequired Skills: Chemical Safety, Clinical Judgment, Clinical Pathology, Collaborative Communications, Detail-Oriented, Hematology, Improvement Projects, Innovation, Intellectual Curiosity, Laboratory Documentation, Laboratory Informatics, Laboratory Information Management System (LIMS), Medical Laboratories, Microscopic Imaging, Morphology, Regulatory Compliance, Regulatory Requirements, Team Collaboration, Technical Leadership, Urinalysis. The successful candidate will ensure accurate, timely, and compliant delivery of laboratory data, and collaborates with stakeholders across functions to support nonclinical studies and development decisions across the pipeline from early discovery to submissions and post-marketing requirements.
Medical Director, Oncology Clinical Development GSK plcMedical Director, Oncology Clinical DevelopmentCollegeville, PA$222,750–$371,250 / yearUse medical expertise to contribute to the end-to-end (protocol concept to final study report) and timely delivery of clinical trials while ensuring patient safety, scientific integrity, and consistency with the clinical development strategy; demonstrate ability to incorporate global considerations into decision making. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.