Medical Director/Senior Medical Director, Clinical Development

Found in: Jooble US O C2 - 2 weeks ago


Maryland, United States Muraloncology Full time

Medical Director/Senior Medical Director, Clinical Development
Clinical Development
Full-Time
The Medical Director/Senior Medical Director in Clinical Development will serve as the Clinical Lead for one or more immune-oncology clinical trials. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions.
Serves on cross-functional teams for assigned programs, working with other team members to drive program and clinical strategy to registration in applicable populations and indications.
Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).
Serves as the medical monitor for assigned studies including design, execution and interpretation study data.
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
Acts as liaison between Clinical Development and other internal groups for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
Establishes strong collaborations with study investigators, outside medical experts and represents Mural during investigator meetings and advisory boards.
Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas.
MD, DO or equivalent ex-US medical degree with 4+ years’ experience for Director, 6+ years for Senior Director.
~4+ years clinical trial experience is a must.
~ Board certification/eligibility in oncology, or another relevant specialty highly desired.
~ Prior regulatory submission experience highly desired.
~ Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
~ Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Mural Oncology also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Mural Oncology is an E-Verify employer.
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