Muraloncology
Senior Director/Executive Director, Clinical Pharmacology
Muraloncology, Chicago, Illinois, United States,
Senior Director/Executive Director Clinical Pharmacology
Job Category:
Late Stage Clinical DevelopmentRequisition Number:
SENIO001046Posted: August 22, 2024Full-TimeLocations
Waltham, MA:852 Winter StreetWaltham, MA 02451, USAMural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to address areas of unmet need for patients with a variety of cancers.Essential Areas of Responsibility:The Senior Director will serve as the primary clinical pharmacology lead providing clinical pharmacology and bioanalytical expertise to the multidisciplinary project teams at Mural Oncology.He/she will develop and implement clinical pharmacology strategy and will be responsible for designing, implementing and analyzing PK & PD studies for both new and existing oncology agents, in preparation for regulatory submissions (including INDs and BLAs).A core scientific responsibility is ensuring optimal doses and dosage regimens in patients, and as such, the successful candidate must be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK).The incumbent will design, conduct and/or manage IND-enabling studies, design and review clinical pharmacology study protocols and support clinical trials, conduct pharmacokinetic modeling and non-compartmental analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions.He/she will work with both internal and external stakeholders to deliver robust bioanalytical strategies and sound bioanalytical assay designs.He/she will author and review relevant sections of clinical study protocols, analysis plans, and study reports.This role will work intensively on domestic and international regulatory filing activities and documents.The Senior Director supports multiple programs through participation on internal project working teams.Minimum Education & Experience Requirements:Ph.D. or PharmD or equivalent in life sciences, pharmaceutical sciences or related field.Direct experience with pharmacokinetic modeling, bioanalytical chemistry, and nonclinical ADME are desirable attributes.Drug development leader with 10-12 years of experience clinical pharmacology and pharmacokinetic-pharmacodynamic modeling in pharmaceutical or biotechnology industry, with at least 5 years in oncology drug development.Experience in noncompartmental pharmacokinetic analysis and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (eg: INDs, NDAs, CTDs) is required.NDA/BLA submission experience in oncology is a specific requirement.Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology and dose optimization; experience having direct interaction with FDA, including submission of IND, NDA/BLA and other regulatory documents is required.The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.Demonstrated experience with non-compartmental analysis required; compartmental modeling experience with NONMEM, population pharmacokinetic analyses, pharmacometric/PK-PD modeling is required.Familiarity with statistical approaches and programs for PK/PD data analysis is required.Ability to oversee contractors in addition to being an individual contributor.Scientific writing and presentation skills are essential; peer-reviewed publications in a relevant field required.Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate.Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
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Job Category:
Late Stage Clinical DevelopmentRequisition Number:
SENIO001046Posted: August 22, 2024Full-TimeLocations
Waltham, MA:852 Winter StreetWaltham, MA 02451, USAMural Oncology is a clinical-stage oncology business focused on discovering and developing immunotherapies that may meaningfully improve the lives of patients with cancer. By leveraging its core competencies in immune cell modulation and protein engineering, Mural Oncology has developed a portfolio of novel, investigational cytokine therapies designed to address areas of unmet need for patients with a variety of cancers.Essential Areas of Responsibility:The Senior Director will serve as the primary clinical pharmacology lead providing clinical pharmacology and bioanalytical expertise to the multidisciplinary project teams at Mural Oncology.He/she will develop and implement clinical pharmacology strategy and will be responsible for designing, implementing and analyzing PK & PD studies for both new and existing oncology agents, in preparation for regulatory submissions (including INDs and BLAs).A core scientific responsibility is ensuring optimal doses and dosage regimens in patients, and as such, the successful candidate must be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK).The incumbent will design, conduct and/or manage IND-enabling studies, design and review clinical pharmacology study protocols and support clinical trials, conduct pharmacokinetic modeling and non-compartmental analyses, and incorporate findings into study report and regulatory documents as well as participate directly in regulatory interactions.He/she will work with both internal and external stakeholders to deliver robust bioanalytical strategies and sound bioanalytical assay designs.He/she will author and review relevant sections of clinical study protocols, analysis plans, and study reports.This role will work intensively on domestic and international regulatory filing activities and documents.The Senior Director supports multiple programs through participation on internal project working teams.Minimum Education & Experience Requirements:Ph.D. or PharmD or equivalent in life sciences, pharmaceutical sciences or related field.Direct experience with pharmacokinetic modeling, bioanalytical chemistry, and nonclinical ADME are desirable attributes.Drug development leader with 10-12 years of experience clinical pharmacology and pharmacokinetic-pharmacodynamic modeling in pharmaceutical or biotechnology industry, with at least 5 years in oncology drug development.Experience in noncompartmental pharmacokinetic analysis and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents (eg: INDs, NDAs, CTDs) is required.NDA/BLA submission experience in oncology is a specific requirement.Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology and dose optimization; experience having direct interaction with FDA, including submission of IND, NDA/BLA and other regulatory documents is required.The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.Demonstrated experience with non-compartmental analysis required; compartmental modeling experience with NONMEM, population pharmacokinetic analyses, pharmacometric/PK-PD modeling is required.Familiarity with statistical approaches and programs for PK/PD data analysis is required.Ability to oversee contractors in addition to being an individual contributor.Scientific writing and presentation skills are essential; peer-reviewed publications in a relevant field required.Understanding of, and compliance with, regulatory, protocol, standard operating procedures, and Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) as appropriate.Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
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