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Location: West Lafayette, IN
Company Overview: The Low Institute for Therapeutics is a nonprofit research organization established to reduce human suffering from disease based on the pioneering work of Dr. Philip Low, Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry at Purdue University. The Low Institute is focused on advancing clinical studies of innovative medicines designed to precisely treat a wide range of diseases by preferentially targeting diseased tissue, thereby improving efficacy, reducing side effects and improving patient outcomes. The institute is focused on diseases which significantly impact human health, including malaria, many types of cancer, chronic kidney disease, pulmonary fibrosis, heart failure, rheumatoid arthritis, organ transplant rejection, fatty liver disease, Alzheimer’s disease, sickle cell anemia and bone fractures.
Position Summary: The Director/Sr Director of Clinical Operations will provide strategic leadership and hands-on oversight for the planning, execution, and delivery of clinical trial programs. This position will partner closely with Medical Affairs and Nonclinical Development to ensure that study designs are operationally viable, patient-centric, and executed with "inspection-ready" quality. This role is critical in driving the strategic direction and execution of clinical programs, supporting regulatory strategy and submissions, and ultimately ensuring the successful transition of drug candidates from discovery to the clinic.
Key Responsibilities:
● Strategic Leadership: Develop and implement the overall strategy for multiple clinical drug development programs, aligning with the company's goals and objectives.
● Study Planning & Design: Collaborate with Medical Directors to finalize protocols, informed consent forms (ICFs), and Case Report Forms (CRFs).
● Innovation: Evaluate the use of Decentralized Clinical Trials (DCTs), adaptive trial designs, and digital health technologies to streamline data collection.
● Feasibility: Lead the assessment of global patient populations, standard of care variations, and competitive landscape to determine the best geographies for enrollment.
● Collaboration: Work closely with cross-functional teams, including discovery, nonclinical development, CMC, regulatory affairs, and external partners, to ensure seamless progression of drug candidates.
● Site Relationship Management: Oversee the selection of high-performing clinical sites and Principal Investigators (PIs)
● Oversight and CRO Management: Lead the selection, qualification, and management of Contract Research Organizations (CROs) and third-party vendors (central labs, IRT, etc.).
● Present Programs: Present data and findings to the Board of Directors, Scientific Advisory Boards, strategic partners, and company leadership.
● Data Analysis: Interpret and present preclinical data to support decision-making and regulatory submissions.
● Regulatory Compliance: Work with Regulatory Affairs to comply with regulatory requirements and industry standards. Ensure the Trial Master File (TMF) is inspection-ready at all times for potential audits.
● Writing: Direct the writing of the clinically-relevant sections of regulatory documents.
● Risk Mitigation: Proactively identify operational risks (e.g., supply chain disruptions, geopolitical shifts) and implement mitigation strategies.
● Budget Management: Anticipate budget and execute the strategic clinical operating plans, allocate financial and human capital resources, set priorities and
adjust plans as appropriate, and ensure that monthly actual expenses are in line with the budget.
● Innovation: Stay abreast of the latest scientific advancements and technologies in drug development to drive innovation within the preclinical team.
Qualifications:
● Education: Bachelor’s or Master’s degree in a scientific or healthcare field (RN, PharmD, PhD, or Life Sciences).
● Experience: 5+ years in clinical research, with at least 3 years of direct study management experience at a Sponsor or CRO.
● Knowledge: Deep understanding of ICH-GCP guidelines and the drug development lifecycle(Phase 1–4).
● Technical Skills: Proficiency with EDC (Electronic Data Capture), IRT (Interactive Response Technology), and CTMS (Clinical Trial Management System) platform
● Excellent leadership, communication, and interpersonal skills.
● Ability to work effectively in a fast-paced, dynamic environment.
● Ability to build strong relationships with investigating physicians and potential future investigators.
● Experience with managing external collaborations and CROs (Contract Research Organizations).
● Possesses the highest personal integrity and an impeccable professional reputation.
● Willingness to travel domestically and internationally as required.
Benefits:
● Competitive salary and bonus structure.
● Comprehensive health insurance.
● Retirement savings plan with company match.
● Opportunities for professional development and career advancement.
● Collaborative and inclusive work environment.
Application Process: Interested candidates should submit their resume and a cover letter detailing their qualifications and experience to jobs@lowinsititue.org.
Location: West Lafayette, IN
Company Overview: The Low Institute for Therapeutics is a nonprofit research organization established to reduce human suffering from disease based on the pioneering work of Dr. Philip Low, Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry at Purdue University. The Low Institute is focused on advancing clinical studies of innovative medicines designed to precisely treat a wide range of diseases by preferentially targeting diseased tissue, thereby improving efficacy, reducing side effects and improving patient outcomes. The institute is focused on diseases which significantly impact human health, including malaria, many types of cancer, chronic kidney disease, pulmonary fibrosis, heart failure, rheumatoid arthritis, organ transplant rejection, fatty liver disease, Alzheimer’s disease, sickle cell anemia and bone fractures.
Position Summary: The Director/Sr Director of Clinical Operations will provide strategic leadership and hands-on oversight for the planning, execution, and delivery of clinical trial programs. This position will partner closely with Medical Affairs and Nonclinical Development to ensure that study designs are operationally viable, patient-centric, and executed with "inspection-ready" quality. This role is critical in driving the strategic direction and execution of clinical programs, supporting regulatory strategy and submissions, and ultimately ensuring the successful transition of drug candidates from discovery to the clinic.
Key Responsibilities:
● Strategic Leadership: Develop and implement the overall strategy for multiple clinical drug development programs, aligning with the company's goals and objectives.
● Study Planning & Design: Collaborate with Medical Directors to finalize protocols, informed consent forms (ICFs), and Case Report Forms (CRFs).
● Innovation: Evaluate the use of Decentralized Clinical Trials (DCTs), adaptive trial designs, and digital health technologies to streamline data collection.
● Feasibility: Lead the assessment of global patient populations, standard of care variations, and competitive landscape to determine the best geographies for enrollment.
● Collaboration: Work closely with cross-functional teams, including discovery, nonclinical development, CMC, regulatory affairs, and external partners, to ensure seamless progression of drug candidates.
● Site Relationship Management: Oversee the selection of high-performing clinical sites and Principal Investigators (PIs)
● Oversight and CRO Management: Lead the selection, qualification, and management of Contract Research Organizations (CROs) and third-party vendors (central labs, IRT, etc.).
● Present Programs: Present data and findings to the Board of Directors, Scientific Advisory Boards, strategic partners, and company leadership.
● Data Analysis: Interpret and present preclinical data to support decision-making and regulatory submissions.
● Regulatory Compliance: Work with Regulatory Affairs to comply with regulatory requirements and industry standards. Ensure the Trial Master File (TMF) is inspection-ready at all times for potential audits.
● Writing: Direct the writing of the clinically-relevant sections of regulatory documents.
● Risk Mitigation: Proactively identify operational risks (e.g., supply chain disruptions, geopolitical shifts) and implement mitigation strategies.
● Budget Management: Anticipate budget and execute the strategic clinical operating plans, allocate financial and human capital resources, set priorities and
adjust plans as appropriate, and ensure that monthly actual expenses are in line with the budget.
● Innovation: Stay abreast of the latest scientific advancements and technologies in drug development to drive innovation within the preclinical team.
Qualifications:
● Education: Bachelor’s or Master’s degree in a scientific or healthcare field (RN, PharmD, PhD, or Life Sciences).
● Experience: 5+ years in clinical research, with at least 3 years of direct study management experience at a Sponsor or CRO.
● Knowledge: Deep understanding of ICH-GCP guidelines and the drug development lifecycle(Phase 1–4).
● Technical Skills: Proficiency with EDC (Electronic Data Capture), IRT (Interactive Response Technology), and CTMS (Clinical Trial Management System) platform
● Excellent leadership, communication, and interpersonal skills.
● Ability to work effectively in a fast-paced, dynamic environment.
● Ability to build strong relationships with investigating physicians and potential future investigators.
● Experience with managing external collaborations and CROs (Contract Research Organizations).
● Possesses the highest personal integrity and an impeccable professional reputation.
● Willingness to travel domestically and internationally as required.
Benefits:
● Competitive salary and bonus structure.
● Comprehensive health insurance.
● Retirement savings plan with company match.
● Opportunities for professional development and career advancement.
● Collaborative and inclusive work environment.
Application Process: Interested candidates should submit their resume and a cover letter detailing their qualifications and experience to jobs@lowinsititue.org.
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Low Institute For Therapeutics
3000 Kent Ave, Suite 1956
West Lafayette, IN 47906
Low Institute For Therapeutics
3000 Kent Ave, Suite 1956
West Lafayette, IN 47906