Job Code:
Location: Mid-West

Purpose:

The varying levels of Clinical Research Physician (CRP) work within a multifunctional team to provide clinical and scientific expertise as well as leadership in the planning of global clinical trials for new compounds in development. This involves working with the clinical development team to plan clinical research on global basis in support of registration of new candidate compounds. In addition, the clinical research physician may work with basic research scientists to identify lead compounds and plan pre-clinical studies. Core tasks will be delegated based on level of experience.



Location:

Biopharmaceutics/Translational Medicine



Position Responsibilities:

Design and oversee implementation of all clinical pharmacology studies conducted to support later stage (Phase 2 and 3) registration programs in development. Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and selected patient and special populations.
Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology/biopharmaceutics research.
Design and oversee implementation of methods development and biomarker qualification studies.
Collaborate with other functional areas (Global Product Safety, PK/PD, Diagnostic and Experimental Medicine) in the development of methods for assessing special clinical safety pharmacology studies (e.g. TQT studies, disease mechanistic studies, etc.).
Collaborate with other quantitative scientists (e.g. PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progress and drug-disease response in silico models.
Work closely with discovery and development research scientists in the qualification of research strategies, and pre-clinical studies needed to support later-stage development.
Interact with consultants and clinical investigators to plan, initiate, and conduct global clinical pharmacology trials.
Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and outside audiences.
Publish results of research projects and clinical trials as appropriate.
Provide advice and consultation to global business unit with regard to potential markets for development compounds and in-licensed projects or compounds.
Design and write protocols.
Support development of documents for the conduct of studies in collaboration with functions and operations staff and affiliates in accordance with GCP and local requirements.
Identify investigators.
Prepare clinical pharmacology/biopharmaceutics sections of IB, NDA and other regulatory documents.
Advise CDAs/CRAs on trial specifics and clarify questions and issues during conduct of trial.
Review all adverse events and initiate appropriate action. Assure communication of risks to the affiliates, investigators, ethical review boards and patients. Implement appropriate pharmacovigilance actions as needed during the conduct of the study in collaboration with the global product safety department.
Interpret results and write final reports for clinical pharmacology/biopharmaceutics trials. Provide clinical reports for local and international regulatory purposes.
Develop and review labeling modifications in collaboration with the regulatory and safety group.
Support business development in collaboration with the regulatory and corporate affairs group.
Establish, support or review any scientific information in respect to customer questions or media requests.
Support business units with planning of symposia/publications/speaking engagements.
Consider, review, and develop pharmaco-epidemiologic (quality of life, cost/effectiveness) and health economic aspects.
Establish and maintain contacts with external experts and opinion leaders on a regional and possibly international basis.
Participate in extramural scientific relations such as pharmaceutical industry associations and scientific and medical organizations on local and international scale.
Maintain awareness of current clinical practices through experience or contacts.
Advise cross-functional development team on current standards of care/treatment paradigms as well as emerging clinical trends.
Attend scientific symposia as well as administrative workshops in order to keep and develop an appropriate educational level for professional services.
Support the clinical development manager in preparation and administration of medical budget.
Actively set and meet individual professional development goals and contribute to the development of others.
Participate in patent development.


Requirements:

Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or the comparable level of clinical training relevant to the country of hiring. US trained physicians must have achieved board eligibility or certification
At least 2 years of training or experience in Clinical Pharmacology, Pharmacokinetics, or Clinical Statistics is desired.
Sound understanding of scientific principles, experimental method and study design.
Strong organizational skills.
Excellent written and verbal communication abilities.
Excellent problem-solving abilities through utilization of good judgment and networking skills.
Strong interpersonal skills. Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
Excellent teamwork skills.
Strong self-management skills.


Education and Work Experience Required:

Must be medically qualified, preferably with postgraduate qualifications and/or accreditation in area of specialty, for example a MD/DO with board certification or eligible in the area of specialty.
Should have basic or clinical research experience with a record of scientific achievement.
Experience in patient care is desirable.
Significant experience and/or training in the field of clinical immunology, immunology, or rheumatology is highly desired.