Meridabio
Associate Director, Translational Biomarkers At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking a hands on and scientifically rigorous Associate Director of Translational Biomarkers to join our Translational Research team, reporting to the VP of Translational Research. In this role, you will bridge the gap between discovery research and clinical development by taking ownership of biomarker assay development and implementation in clinical studies. You will work closely with the Research team to optimize and characterize complex assays for robustness before transferring them to external partners. You will oversee their qualification or fit for purpose validation and oversee the lifecycle of these assays to support our clinical trials in antibody driven diseases. This is a hybrid role requiring a willingness to work in the lab to ensure assay readiness, combined with the operational acumen to manage external partners and deliver high quality data. Key Responsibilities Proactively and collaboratively design and refine biomarker strategies to interrogate mechanism of action and create value from Merida clinical studies. Working hands on and closely with the Research team, develop and optimize innovative exploratory biomarker assays for clinical readiness, ensuring they are optimized for robustness and reproducibility prior to transfer. These assays may be based on flow cytometry, ELISPOT, MSD, or other platforms. Identify, select, and manage external CROs and specialty labs for clinical biomarker testing. Oversee the transfer and qualification and/or validation of biomarker assays at CROs, ensuring alignment with regulatory expectations and clinical timelines. Monitor ongoing assay performance and data quality during clinical trials, providing real time interpretation and troubleshooting. Partner with Clinical and Clinical Operations to help define sample collection logistics to support generation of quality data. Contribute to technical content for biomarker related sections of clinical study protocols, laboratory manuals, and regulatory documents (e.g., INDs, IBs). Analyze, interpret, and communicate complex biomarker data to support internal decision making. Qualifications PhD in Immunology, Cell Biology, Pharmacology, or a related discipline with 6+ years of relevant industry experience, OR MS/BS with 8+ years of experience. Extensive hands on experience developing and optimizing Flow Cytometry, ELISPOT, and/or multiplexed ligand binding assays (e.g., MSD, Luminex). Proven experience with tech transferring assays to CROs and managing external vendors for validation and clinical sample analysis. Experience working in a clinical stage biotech environment, with a strong understanding of "fit for purpose" biomarker validation principles. Strong understanding of cellular immunology and cytokine biology, particularly in the context of autoimmune or antibody driven diseases. Ability to work successfully in a fast paced, matrixed team environment with competing priorities. Excellent problem solving skills with the ability to "follow up and follow through" to connect technical problems with operational solutions. Strong verbal and written communication skills, with the ability to summarize complex data for cross functional teams. Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we're sharing our hiring range for this role upfront: typically for the Associate Director level we target $200,000 to $240,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we're proud to offer a comprehensive benefits package designed to support you both personally and professionally. Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Associate Director, Translational Biomarkers At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. Merida Biosciences is seeking a hands on and scientifically rigorous Associate Director of Translational Biomarkers to join our Translational Research team, reporting to the VP of Translational Research. In this role, you will bridge the gap between discovery research and clinical development by taking ownership of biomarker assay development and implementation in clinical studies. You will work closely with the Research team to optimize and characterize complex assays for robustness before transferring them to external partners. You will oversee their qualification or fit for purpose validation and oversee the lifecycle of these assays to support our clinical trials in antibody driven diseases. This is a hybrid role requiring a willingness to work in the lab to ensure assay readiness, combined with the operational acumen to manage external partners and deliver high quality data. Key Responsibilities Proactively and collaboratively design and refine biomarker strategies to interrogate mechanism of action and create value from Merida clinical studies. Working hands on and closely with the Research team, develop and optimize innovative exploratory biomarker assays for clinical readiness, ensuring they are optimized for robustness and reproducibility prior to transfer. These assays may be based on flow cytometry, ELISPOT, MSD, or other platforms. Identify, select, and manage external CROs and specialty labs for clinical biomarker testing. Oversee the transfer and qualification and/or validation of biomarker assays at CROs, ensuring alignment with regulatory expectations and clinical timelines. Monitor ongoing assay performance and data quality during clinical trials, providing real time interpretation and troubleshooting. Partner with Clinical and Clinical Operations to help define sample collection logistics to support generation of quality data. Contribute to technical content for biomarker related sections of clinical study protocols, laboratory manuals, and regulatory documents (e.g., INDs, IBs). Analyze, interpret, and communicate complex biomarker data to support internal decision making. Qualifications PhD in Immunology, Cell Biology, Pharmacology, or a related discipline with 6+ years of relevant industry experience, OR MS/BS with 8+ years of experience. Extensive hands on experience developing and optimizing Flow Cytometry, ELISPOT, and/or multiplexed ligand binding assays (e.g., MSD, Luminex). Proven experience with tech transferring assays to CROs and managing external vendors for validation and clinical sample analysis. Experience working in a clinical stage biotech environment, with a strong understanding of "fit for purpose" biomarker validation principles. Strong understanding of cellular immunology and cytokine biology, particularly in the context of autoimmune or antibody driven diseases. Ability to work successfully in a fast paced, matrixed team environment with competing priorities. Excellent problem solving skills with the ability to "follow up and follow through" to connect technical problems with operational solutions. Strong verbal and written communication skills, with the ability to summarize complex data for cross functional teams. Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we're sharing our hiring range for this role upfront: typically for the Associate Director level we target $200,000 to $240,000 . The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we're proud to offer a comprehensive benefits package designed to support you both personally and professionally. Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Meridabio
Director, Drug Safety & Pharmacovigilance At Merida Biosciences, we are pioneering true precision medicines for antibody driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody driven diseases. Reporting directly to the CMO of Merida, the Director, Drug Safety and Pharmacovigilance is a leadership role responsible for managing the safety surveillance, reporting, and risk management strategies for our clinical stage development assets. This individual will serve as a scientific safety expert, while also providing strategic oversight of outsourced pharmacovigilance operations and reporting activities conducted by CRO vendor(s). This role requires a deep understanding of safety science combined with proven experience in vendor management and operational excellence. Responsibilities: Lead ongoing safety review and signal detection, evaluation, and management activities for development assets Supports build out of safety analytics and reporting infrastructure, such as developing standard procedures and templates Author, review, and approve aggregate safety reports, including DSURs, PBRERs/PSURs, and ad hoc safety assessments. Serve as the lead/coordinator and key contributor for internal Safety Review Committees or other safety governance bodies at the trial and asset level. Provide expert safety science input for key regulatory and clinical documents, such as protocols, informed consents, Investigator's Brochures, Clinical Study Reports, and integrated summaries of safety Strategizing and drafting of responses to regulatory inquiries on safety issues inclusive of defining MedDRA search strategy Supports activities related to new drug applications and other regulatory filings Represent drug safety at regulatory inspections i.e. MHRA, FDA, EMA, etc Serve as the primary point of contact and relationship manager for outsourced PV CRO vendor(s), ensuring a collaborative and effective partnership. Oversee CRO vendor budget, review invoices, and participate in contract renewals and negotiations. Establish, monitor, and report on Key Performance Indicators (KPIs) and quality metrics to ensure the CRO's adherence to timelines, regulatory requirements, and quality standards. Provide oversight of the CRO's case processing (ICSR) and regulatory reporting activities, ensuring all safety data is handled with the highest level of accuracy and compliance. Supports safety database and clinical database adjudication May lead gap analysis to ensure alignment with changes in global regulations Requirements: Advanced degree in a biologic/medical/clinical/nursing field required (PharmD, Nurse Practitioner, Ph.D.) At least 8 + years' experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry. Experience working in a start up environment is desirable. Deep knowledge and understanding of US and EU safety regulations pre and post marketing Demonstrated expertise in signal detection, risk management, and authoring aggregate safety reports for both investigational and marketed products Strong experience with clinical development including risk/benefit analysis and safety assessment Experience directly managing CROs, PV service providers, or other outsourced vendors Experience successfully leading or playing a key role in regulatory authority interactions and inspections. Strong analytical, problem solving and scientific writing and communication skills Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we're sharing our hiring range for this role upfront: typically for the Director level we target between $210,000-$243,000. The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we're proud to offer a comprehensive benefits package designed to support you both personally and professionally. Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
Director, Drug Safety & Pharmacovigilance At Merida Biosciences, we are pioneering true precision medicines for antibody driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody driven diseases. Reporting directly to the CMO of Merida, the Director, Drug Safety and Pharmacovigilance is a leadership role responsible for managing the safety surveillance, reporting, and risk management strategies for our clinical stage development assets. This individual will serve as a scientific safety expert, while also providing strategic oversight of outsourced pharmacovigilance operations and reporting activities conducted by CRO vendor(s). This role requires a deep understanding of safety science combined with proven experience in vendor management and operational excellence. Responsibilities: Lead ongoing safety review and signal detection, evaluation, and management activities for development assets Supports build out of safety analytics and reporting infrastructure, such as developing standard procedures and templates Author, review, and approve aggregate safety reports, including DSURs, PBRERs/PSURs, and ad hoc safety assessments. Serve as the lead/coordinator and key contributor for internal Safety Review Committees or other safety governance bodies at the trial and asset level. Provide expert safety science input for key regulatory and clinical documents, such as protocols, informed consents, Investigator's Brochures, Clinical Study Reports, and integrated summaries of safety Strategizing and drafting of responses to regulatory inquiries on safety issues inclusive of defining MedDRA search strategy Supports activities related to new drug applications and other regulatory filings Represent drug safety at regulatory inspections i.e. MHRA, FDA, EMA, etc Serve as the primary point of contact and relationship manager for outsourced PV CRO vendor(s), ensuring a collaborative and effective partnership. Oversee CRO vendor budget, review invoices, and participate in contract renewals and negotiations. Establish, monitor, and report on Key Performance Indicators (KPIs) and quality metrics to ensure the CRO's adherence to timelines, regulatory requirements, and quality standards. Provide oversight of the CRO's case processing (ICSR) and regulatory reporting activities, ensuring all safety data is handled with the highest level of accuracy and compliance. Supports safety database and clinical database adjudication May lead gap analysis to ensure alignment with changes in global regulations Requirements: Advanced degree in a biologic/medical/clinical/nursing field required (PharmD, Nurse Practitioner, Ph.D.) At least 8 + years' experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry. Experience working in a start up environment is desirable. Deep knowledge and understanding of US and EU safety regulations pre and post marketing Demonstrated expertise in signal detection, risk management, and authoring aggregate safety reports for both investigational and marketed products Strong experience with clinical development including risk/benefit analysis and safety assessment Experience directly managing CROs, PV service providers, or other outsourced vendors Experience successfully leading or playing a key role in regulatory authority interactions and inspections. Strong analytical, problem solving and scientific writing and communication skills Ability to interact effectively with people of multiple disciplines and cultures both within and outside the company on a global basis Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we're sharing our hiring range for this role upfront: typically for the Director level we target between $210,000-$243,000. The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we're proud to offer a comprehensive benefits package designed to support you both personally and professionally. Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.