Under the guidance of the Clinical Leader, the Sr. CRS is responsible for the design and scientific oversight of clinical studies in support of the Product Development Plan. Sr. CRS responsibilities include ensuring that the clinical study is conducted in accordance with the protocol and in conjunction with the Clinical Leader and all other team members ensuring overall timeline adherence and performance against plan of the clinical study. At times, business travel will be necessary.
The main responsibility of the Sr. CRS is the design and scientific oversight of clinical studies in support of the Product Development Plan. For assigned studies, there are numerous high-level deliverables for which the Sr. CRS is accountable to the study team. Incumbent may conduct the following (or manage the CRO) with minimal supervision in accordance with ICH/GCP/FDA guidelines, Purdue policies/SOPs/WPDs, and protocol specifications:
- Prepare clinical trial synopses and protocols
- Review of subject information including Informed Consent Forms
- Prepare CRO / Vendor / Site protocol training materials
- Work with Clinical Leader to manage protocol compliance, and oversee subject safety
- Facilitate the interface between the Medical Monitor and the Clinical Sites / CRO
- Support Regulatory Affairs reporting of safety data and IND annual reports.
- Prepare subject safety narratives
- Review scientific data
- Prepare and review clinical study reports
- Create/Manage Study Documentation including confirmation that required documents are archived and available.
- Proactive issue identification, evaluation and resolution
- May serve as a Product/Project Team member, acting with a high degree of independence and autonomy. In addition, the responsibilities for the Sr. CRS may include:
- Contributing to and/or leading teams in the preparation of clinical program documents (investigator brochure, IND annual report, Health Authority (HA) briefing books, and submissions)
- Creating new, enhancing and maintaining current medical management templates, standards and communication tools.
- Contribute to multi-disciplinary task forces to support continuous improvement.
- Review / author scientific publications and posters. Present at scientific forums
- Other activities as assigned.
Doctoral (PhD) level degree (PharmD may be acceptable).
Required Experience & Technical Requirements
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.
- Must have a minimum of five years clinical development experience in a pharmaceutical/biotechnology/device company (pharmaceutical preferred).
- Experience preferred with pediatric or complex/hard to enroll studies
- Demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
- Working knowledge of the IND/NDA process acquired through direct industry experience is required.
- Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.
- Knowledge of basic statistics and pharmacokinetics a plus.
- Strong experience in medical/scientific writing skills
- Must have thorough knowledge of Drug Development process including study design, protocol writing and the roles for the various functional areas within clinical development
- Ideally, this incumbent will have broad knowledge of medical writing and general quality of regulatory submission data within the pharmaceutical arena.
- Versatility, flexibility, and superior communication skills are essential
- Must have the ability to work with a multi-disciplinary team of professionals
- Experience with partnerships, strategic alliances, mergers and acquisitions preferred.
- Ability to function and complete tasks independently
- Ability to delegate less critical tasks and to supervise less experienced scientistsBrief Description/Overview:
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.