Clinical Scientist Jobs

Kiel Laboratories, Inc., is a small pharmaceutical research and development company located near Atlanta, Georgia with over 200 years of combined experience in formulation development, analytical services, manufacturing, clinical and regulatory affairs, consulting, and project management for pharmaceutical products. We are experts in 505(b)(2) NDA Product Development and Approval. Kiel’s mission is to provide non-cGMP services and cGMP consulting for marketers, manufacturers, and researchers in the Pharmaceutical Space. We are an employee-owned company (ESOP).

The Clinical Scientist is a key member of the Kiel clinical team and partners closely with the Medical Director, applying technical and scientific excellence to develop clinical development plans and execution of clinical trials to meet the needs of internal and external customers. The Clinical Scientist will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on protocol-specific activities. The Clinical Scientist will help and work in collaboration to drive the design, planning, and implementation of study protocols for assigned investigational products and play a key role in supporting related regulatory activities, as well as assist with data interpretation and communication to both internal and external stakeholders including FDA.

Responsibilities:

• Assist in support of clinical trial objectives; respond to or triages questions for appropriate escalations.
• Support publication strategy execution including collaboration with investigators, key opinion leaders (KOL), and other internal/external stakeholders.
• Assist in preparation of Clinical Trial Agreements (CTA) with foreign ministries of health.
• Provide primary support for acquisition, labelling, shipment, and other aspects of clinical supplies for planned clinical and non-clinical studies.
• Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences, and publications.
• Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature.
• Obtain quotes from non-clinical and/or clinical research organizations (CRO) for proposed non-clinical and clinical studies.
• Assist in interpretation of non-clinical and clinical pharmacokinetic, pharmacodynamic, safety, and efficacy study data.
• Perform other duties as assigned related to clinical programs.
• Ability to travel as required.
• Provide technical and scientific guidance in the direction, planning, design, implementation, and interpretation of all phases of sponsored clinical trials and related data collection activities.
• In collaboration with CRO, develop clinical study synopses, protocols, informed consent documents (ICD), training documents, and contribute to preparation and review of final clinical study reports (CSR), investigational brochures (IB), and other related clinical and regulatory documents.
• Collaborate with cross-functional teams to evaluate feasibility of new clinical projects, study strategies, and recommend process improvements.
• Assist in selecting qualified Clinical Research Organizations (CRO) to conduct required Phase 1 -IV clinical trials.
• Act as recognized clinical expert for assigned studies both within and external to Kiel and study sponsor.
• Assist with communicating a clear overview of trial results to internal and external partners.
• Attend investigator meetings, industry meetings, and scientific conferences as required.
• Conduct or source persons for clinical monitoring visits and/or auditing of clinical trials on behalf of sponsor.
• Assist in preparation of U.S. FDA regulatory submissions including Pre-IND meeting requests/meeting packets, INDs, Pediatric Study Plans, NDA submissions, Advisory Committee Meeting packets, and responding to information requests.

Qualifications (including knowledge & skills)

Education/Experience:

• Experience at a pharmaceutical, CRO, or biotechnology company as a clinical scientist or related role highly desired.
• Experience with data analysis and interpretation as an understanding of pharmacokinetic, pharmacodynamic, safety, and efficacy principles required.
• Experience in clinical trials strongly preferred. Early drug development and experience in monitoring, auditing, and/or coordinating clinical trials highly desired.
• Advanced PharmD degree in life or health sciences required.

Professional and Personal Requirements:

• Must be willing and possess the expertise to work effectively in a fast-paced, team-based environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
• Working knowledge of drug development process, pharmaceutical industry, GCP, ICH guidelines and FDA regulations is required.
• Ability to make independent, timely and appropriate decisions.
• Demonstrated ability to evaluate, interpret and present complex scientific data (pre-clinical, non-clinical, clinical) to inform scientific hypotheses and development strategy.
• Excellent interpersonal, verbal, and written communication skills. Examples of medical writing skills may be required.
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.