Clinical Research Scientist - Immunology Technical Lead
The primary responsibilities of the Clinical Research Scientist in this role include leading clinical research efforts for late-phase and marketed compounds.
Clinical Planning
* Collaborate with cross-functional teams to develop a comprehensive clinical strategy, including Draft Launch Label and Value Proposition, product lifecycle plan, and study protocol design.
* Contribute to global alignment of clinical strategy and clinical plans.
* Maintain up-to-date knowledge of pre-clinical and clinical data relevant to the molecule.
Clinical Research/Trial Execution and Support
* Collaborate with development teams on scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions.
* Provide protocol oversight and input into informed consent documents.
* Support monitoring of patient safety during studies and participate in global product safety reviews, including tracking and follow-up of adverse events.
* Review and collaborate with Development Medical Director on approval of risk profiles to ensure appropriate communication of risk to study subjects.
* Participate in investigator identification and selection, in conjunction with clinical teams.
* Ensure operational teams have documented completion of administrative requirements for study initiation and conduct, consistent with Good Clinical Practices (GCPs) and local laws and requirements.
* Assist in planning process and participate in study start-up meetings and other activities to provide training and information to investigators and site personnel.
* Serve as resource to clinical operations/clinical research monitors, investigators, and ethical review boards to address questions or clarify issues arising during study conduct.
* Understand and address scientific information needs of all investigators and personnel.
* Review literature, investigate proposals, and publications as requested.
Scientific Data Dissemination/Exchange
* Knowledge of and compliance with local laws and regulations, global policies and procedures, compliance guidelines concerning data dissemination, and interactions with external healthcare professionals.
* Understand and address unsolicited scientific information needs of external healthcare professionals according to guidelines above.
* Participate in reporting of clinical trial data in Clinical Trial Registry activities.
* Support planning of symposia, advisory board meetings, and other meetings with health care professionals.
* Prepare or review scientific information in response to customer questions or media requests.
* Provide telephone follow-up or specific written information requested by healthcare professionals, per global SOPs.
* Establish and maintain collaborations and relationships with external experts, thought leaders, and general medical community on a local, national, regional, and possibly international basis.
* Support medical information associates in preparation and review of medical letters and other medical information materials.
* Support data analysis and development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
* Develop and maintain collaborations and relationships with relevant professional societies.
* Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons, and global patient outcomes personnel.
* Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
Regulatory Support Activities
* Participate in development and review of label changes and labelling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
* Provide medical expertise to regulatory scientists.
* Support/assist in preparation of regulatory reports, including NDAs, FDA annual reports, and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
* Participate in advisory committees.
* Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
Scientific /Technical Expertise and continued development
* Critically read and evaluate relevant medical literature; know status and data from competitive products; and maintain up-to-date knowledge of medical and other scientific developments relevant to the product.
* Responsible for scientific training of clinical study team.
* Acts as scientific consultant and protocol expert for clinical study team members and others in medical.
* Aware of current trends and projections for clinical practice and access in therapeutic area(s) relevant to the product, both near-term (1-2 years) and longer-term (3-5 years).
* Explore and take advantage of opportunities for extramural scientific experiences.
Basic Qualifications
* Advanced health/medical/scientific graduate degree, such as DVM, PharmD, Ph.D., MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and 3-5 years of clinical experience or pharmaceutical experience (2 of which are in clinical development).
OR
* BS or Masters's degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience directly related to at least one of following areas:
* Clinical trial experience
* Experience in areas relevant to drug discovery
* Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, and medical affairs)
Additional Skills/Preferences
* Clinical research or pharmaceutical medicine experience preferred
* 5 years of work experience in immunology
* Minimum of 3 years of professional experience in pharmaceutical drug development with demonstrated experience and knowledge of clinical research and the drug development process.
* Fluent in English, written and verbal communications
* Ability to engage in occasional domestic and international travel to support business of the team.