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In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. The Executive Director will build the clinical pharmacology function to enable the design and efficient execution of all Phase 1 programs across multiple therapeutic areas including epilepsy, psychiatry, and pain.. In addition, the role will require the development of strong working relationships within Clinical Development Department and with other key functions including, for example, Pharmacovigilance and Drug Safety, Regulatory, Discovery, CMC, Translational, Trial Operations, Biostatistics and Program Management.. Provide strategic and clinical pharmacology leadership to all development programs across epilepsy, psychiatry, and pain programs. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Leadership of the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through Clinical Pharmacology testing (Phase 1), and clinical Proof-of-Concept (Phase 2). Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for programs in Phases I through IV of development. Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or clinical pharmacology experiments to validate targets and/or pathways. Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations). Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites around the world.
This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply and CMC teams.. 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical.. Global Regulatory Affairs Chief of Staff Boston, MA $208,200.00-$327,140.00 2 weeks ago.. Associate Director/Director, Regulatory Affairs Senior Director, Global Regulatory Affairs ProFound Therapeutics: Senior Director, IP Counsel Executive Director/Vice President, Regulatory Affairs We’re unlocking community knowledge in a new way.
Associate Director, Regulatory Affairs Strategy.. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Affairs Strategy to join our growing Regulatory team. Associate Director: Must have minimum of 8 years pharmaceutical industry with 6 years in Regulatory affairs strategy.. Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
destinationone Consulting specializes in recruitment across diverse sectors, including Healthcare, Health Tech, Government, Municipalities, Non-Profits, Legal, Public Accounting, Food and more.. The Quality Assurance Coordinator is responsible for monitoring and evaluating the quality of care provided within the healthcare practice, ensuring that standards are met and continuously improved.. Bachelor's degree in Healthcare Administration, Nursing, or a related field; certification in quality management preferred.. Experience in quality assurance or improvement in a healthcare setting.. Disclaimer: We're proactively building a databank for opportunities in Healthcare, Health Tech, Government, Non-Profits, Legal, and more.
Medical Billing & Coding•Understand and document workflows related to medical billing and coding processes.. Ensure compliance with industry standards such as ICD-10, CPT, HCPCS, HIPAA, andMedicare/Medicaid guidelines.. Assist in optimizing revenue cycle management (RCM) through effective processdocumentation.. Strong knowledge of medical billing & coding (ICD-10, CPT, HCPCS, RCM, HIPAA).. Certified Professional Coder (CPC), Certified Professional Biller (CPB), or similarcertification is a plus.
Our Neuroscience team tackles the world's toughest brain health challenges including multiple sclerosis, Alzheimer's disease, Parkinson's disease, myasthenia gravis, epilepsy, major depressive disorder, bipolar disorder, schizophrenia, and autism. Team matrix interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines. Responsible for medical monitoring/reporting and company safety officer activities.. Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting.. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k
The preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and drug modalities and have led regulatory filings for IND and/or CTA opening studies. Own the development of asset-specific Regulatory Development Plans, author and manage creation of IND/CTA & Briefing Books, drive pre-IND meetings and other Health Authority-facing interactions related to specific clinical trials. Advanced degree (M.D., PhD, PharmD, MSc or MPH) with a focus in pharmaceutical sciences, including a minimum of 10 years of pharmaceutical/biotechnology industry experience in Regulatory Affairs lead role with hands-on regulatory experience in all aspects of regulatory affairs. Prior experience in a combination of metabolic diseases and/or immunology drug development is ideal, and experience in rare diseases is a plus. Experience with two or more of the following modalities is required: small molecules, biologics, peptides, nucleic acids, or cell therapies; with experience in novel modalities (e.g., gene editing, RNAi, gene therapy) desirable.
Reporting to the Chief Medical Officer, the Director of Regulatory Affairs will be responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area (TA).. Candidates should demonstrate excellent understanding of drug development and leadership behaviors consistent with level.. Follow company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures for regulatory affairs.. Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject).. Corner’s technology solves the “last mile” problem that has kept researchers from achieving the holy grails of medicine: therapeutic cancer and infectious disease vaccines that provide life-long immunity.
Create protocols for database management, regulatory/IRB compliance, human subject protection, and study recruitment. Additional responsibilities include strategic planning, oversight of IRB submissions and regulatory documentation, compliance with local, federal, and sponsor policies, management of single and multicenter trials, staff education on research policies, budget development and coordination with Research Administration, sponsor relationship management, operational oversight, vendor management, risk mitigation, quality assurance, stakeholder engagement, and data analysis and reporting.. The ideal candidate will have a strong background in clinical research implementation with experience and interest in clinical trials, qualitative studies, and survey research; exceptional leadership skills; and a passion for advancing knowledge around food is medicine to improve health.. Proven track record of managing multiple clinical trials from start-up to close-out, Experience designing and conducting qualitative research studies. Proficiency in survey research methods, including data collection and analysis using platforms such as Qualtrics or REDCap
Collaborate with Drug Metabolism and Pharmacokinetics (DMPK) teams to prepare and submit New Drug Applications (NDAs), focusing on precision in drug labeling.. Develop clinical pharmacology strategies for Phase 3 clinical trials, ensuring alignment with regulatory standards and expectations.. Provide expert clinical pharmacology insights to cross-functional teams, ensuring compliance in trial documentation and strategic regulatory interactions.. PhD, MD, or PharmD with 8-10 years of experience in clinical pharmacology and oncology drug development.. Expert in IND to NDA drug development phases, with skills in clinical trial design, execution, and analysis.
Manage and scale the Pharmacology (Oncology and Metabolism) business responsibly, balancing employee well-being, client satisfaction, and operational efficiency while growing revenues and maintaining high margins.. Support business goals related to finance, operations, client service, employee development, and quality.. Support strategic planning within Pharmacology.. Education: Veterinary or Medical degree (DVM/VMD, MD) and/or Ph. D. in Pharmacology (Oncology and Metabolism) preferred; post-doctoral experience is a plus.. Join us to make an impact in drug development and healthcare improvement.
Additional responsibilities include strategic planning, oversight of IRB submissions and regulatory documentation, compliance with local, federal, and sponsor policies, management of single and multicenter trials, staff education on research policies, budget development and coordination with Research Administration, sponsor relationship management, operational oversight, vendor management, risk mitigation, quality assurance, stakeholder engagement, and data analysis and reporting.. The ideal candidate will have a strong background in clinical research implementation with experience and interest in clinical trials, qualitative studies, and survey research; exceptional leadership skills; and a passion for advancing knowledge around food is medicine to improve health.. Knowledge and skills as typically acquired through completion of a masters degree in science, businessadministration, public health, healthcare administration, or nursing. Proven track record of managing multiple clinical trials from start-up to close-out, Experience designing and conducting qualitative research studies. Proficiency in survey research methods, including data collection and analysis using platforms such as Qualtrics or REDCap
The magic weve created lies in Carbon Healths custom EHR and the collaboration among clinical teams, engineers, and designers who work side-by-side to deliver innovation like our hands free AI charting tool.. Carbon Health is looking for a physician with clinical research experience as a Principal Investigator to join a growing community of healthcare providers to deliver compassionate, evidence-based urgent care and conduct clinical trials in infectious disease and indications related to general medicine, including vaccine research and cardiometabolic health.. Serve as a Principal Investigator for multiple clinical trials, Phases I to IV, where you will be responsible for the clinical research conduct and quality assurance, as well as supervising sub-investigators in their clinical trial work. Review and provide guidance on labs, diagnostic reports, diary reports, safety reports, and AEs/SAEs within a trial. Experience serving as a Principal Investigator on at least 3 prior randomized double blinded therapeutic clinical trials
Research and decipher regulatory sources such as legislative rules, state registers, waiver programs and bulletins regarding payment rules for State Medicaid programs as well as deciphering contractual language regarding commercial payment arrangements. Bachelor’s degree or equivalent experience in healthcare administration, business administration, or a related field.. Five+ years of experience in Medicaid billing, reimbursement, claim payment or cost reporting. Experience with Medicare/Medicare Advantage or commercial billing and reimbursement a plus.. Proficient Microsoft Office skills (i.e., functions, macros, pivot tables, data validation, business requirement writing, etc.)
Join to apply for the Regulatory Specialist role at Beth Israel Deaconess Medical Center.. The Regulatory Specialist supports regulatory compliance for clinical research in the Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC). Regulatory Affairs Specialist - Principal Specialist.. State Regulatory Affairs Specialist, Medicaid and Health PolicyAssociate Director - Global Regulatory Lead, GI & InflammationCompliance Associate, Financial Regulatory Affairs.. Senior Manager, Regulatory Affairs, OperationsRegulatory Affairs CMC Expert - Biologics
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients.. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office.. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.. Vertex is a global biotechnology company that invests in scientific innovation.
Clinical Trial Regulatory Affairs Specialist. We’re looking for a dynamic, passionate Clinical Trial Regulatory Affairs Specialist to join this organization and ensure compliance across all stages of clinical research projects.. Experience: 5 years in clinical research and 3 years in regulatory affairs at a CRO or sponsor, ideally in biotech or pharma, with hands-on involvement in clinical trial processes as well as CRO experience.. Regulatory Compliance – Ensure all clinical trials meet FDA, EMA, and ICH standards.. Documentation Management – Prepare, review, and submit regulatory docs like IND & CTA applications.
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. On-Site: work five days per week on-site with ad hoc flexibility.
This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs.. Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and other departments to gather necessary information and align timelines.. Assist in vendor selection and management for outsourced writing projects, ensuring quality and on-time delivery.. Advanced degree in life sciences (PhD, PharmD, or MS preferred).. Experience with global regulatory submissions (e.g., IND, CTA, NDA, MAA).