Collaborate with clinicians and clinical research organizations (CROs) to lead the clinical research effort at Rhodes Pharmaceuticals. The position leads clinical efforts on pipeline products of the company including protocol development, conduct of studies, and coordination of study reports that evaluate safety and efficacy for NDA/ANDA submission. The incumbent must be adept in clinical research with particular emphasis on pharmacokinetics, pharmacodynamics, behavior, epidemiology, and overall healthcare services relative to effectual and competent treatment plans, service plans and intervention measures.
Oversight responsibility for Rhodes Pharmaceuticals' clinical development function, directing both internal and external operations at CROs and other clinical study centers. Position will support the Company's product pipeline development effort and contribute to decisions regarding the Company's Business Development effort. Principal responsibilities will include:
Provide supportive CMC documentation for ANDA's, IND's, NDA's, CBE's, 505(b)(2)'s.
- Developing and writing trial protocols (outlining the purpose and methodology of a trial);
- Presenting trial protocols to a steering committee and coordinating with ethics committees;
- Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;
- Liaising with doctors/consultants (or investigators) on conducting the trial;
- Setting up the study centers, which includes ensuring each center has the trial materials and training the site staff to trial-specific industry standards;
- Monitoring the trial throughout its duration, which involves visiting the study centers on a regular basis;
- Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);
- Designing data collection forms (CRFs) and collecting completed CRFs from hospitals and general practice centers;
- Writing site visit reports and filing or collating clinical study reports (CSRs);
- Ensuring all unused trial supplies are accounted for and closing down study centers on completion of the trial;
- Discussing results with a medical statistician, who usually writes technical trial reports;
- Archiving study documentation and correspondence;
- Coordinating and preparing final reports and occasionally manuscripts for publication.
Ensure compliance with GCPs, ICH, FDA, state and federal regulations.
- Provide life-cycle management
- Support Company's resource and budget planning
PharmD or PhD with at least 15 years postgraduate experience in product development or clinical research. Other academic degrees in the health or allied sciences acceptable.
Required Experience & Technical Requirements
- Must have a strong experience in clinical research, especially with competencies in neuroscience and neurodegenerative disease. Experience in metabolic disease, autoimmune disease or cardiovascular disease would be a plus.
- Demonstrated leadership abilities to develop and operate within high performance teams.
- Hands-on experience with controlled substances preferred.
- Requires the ability to communicate with employees, vendors, and various levels within Rhodes Pharmaceuticals, Rhodes Technologies, and Purdue.
- Must have experience with various dosage forms including solids, semi-solids, capsules, injectables, and transdermals.
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com . No hard copy resumes will be considered.
Purdue Pharma L.P. - 8 months ago