Clinical Pharmacologist, FSP – Neurology/Immuno Oncology & Metabolic – Remote US
Responsibilities
Through the application of pharmacological training, expertise and relevant therapeutic area experience , the Clinical Pharmacologist (CP) participates in the following: the development, conduct and reporting of global clinical trials for new compounds, the implementation of global clinical trials, the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, grant submissions and contracts, contacts with regulatory and other governmental agencies; and the outreach activities aimed at the external clinical customer community, including thought leaders. In addition, the CP works with the basic research scientists to identify lead compounds and plan pre-clinical studies as well as network with the Business Unit to plan for the clinical pharmacology submission package. The CP serves as a scientific resource for study teams, departments, and others as needed.
The CP is aware of and ensures that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research and are aligned with the medical vision.
The CP may be called upon to participate on additional items including but not limited to internal executive and governance presentations, external key opinion leader interactions, medical outreach/advocacy, and industry conferences.
Core Job Responsibilities
The primary responsibilities of the CP are generally related to clinical pharmacology including early phase exploratory and late phase biopharm submission studies.
The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.
Clinical Planning
- Contribute to the development of the overall strategy and clinical plan for development of clinical compounds, focusing on studies required for product decision or regulatory submission.
- Support preparation of high-level plan for phase 2 and 3 studies for early phase and/or detailed biopharm plan to support submission.
- Collaborate with other functional areas (Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics organization) in the development of methods for assessing special clinical safety pharmacology studies.
- Collaborate with other quantitative scientists (e.g., PK/PD, statistics, molecular epidemiology, ADME, modeling and simulations) to integrate study development and conduct with disease-progression and drug disease response models.
- Contribute, as an integral member of the Clinical Pharmacology team, to global Phase I and II clinical studies as well as submission planning activities.
- Work closely with discovery research scientists in the development of basic research strategies, clinical candidate compound selection, and pre-clinical development.
- Work with Brand Team/Business Unit colleagues to provide appropriate market differentiation and regulatory support in the biopharm submission plan.
Clinical Research/Trial Execution and Support
- Design and oversee implementation of all clinical pharmacology studies. Capabilities include understanding the unique aspects of conducting such studies in healthy volunteers and patient groups/special populations.
- Apply fundamental concepts of clinical pharmacology and clinical pharmacokinetics to clinical pharmacology research.
- Design and oversee implementation methods for development and biomarker qualification studies.
- Design, create, and provide oversight for protocol development.
- 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.
- Collaborate with local clinical research staff, statisticians, health outcomes research scientists and selected consultants and/or investigators in the development of protocols, and data collection requirements.
- Participate in investigator identification and selection, in conjunction with the clinical pharmacology sourcing group.
- Review and provide input to risk profiles and local informed consent documents as required, ensuring appropriate communication of risk to study subjects.
- Provide oversight ensuring that operational team has documented the completion of administrative requirements for study initiation and conduct (i.e., ethical review board, informed consent, regulatory approval/notification) 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 the appropriate training and information to investigators and site personnel.
- Serve as resource to clinical trial managers, clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with global patient safety policies and procedures.
- Implement and communicate appropriate pharmacovigilance actions as needed during conduct of the study in collaboration with global patient safety.
- Provide appropriate oversight and partnership with Third Party Organizations to ensure successful study execution.
Scientific Data Dissemination/Exchange
- Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals/customers.
- Address the unsolicited scientific questions and information needs of external health care professionals according to guidelines above.
- Participate in reporting of clinical trial data in Clinical Trial Registry activities.
- Partner with NPP (New Product Planning) and scientific communications staff on publication strategy and process.
- Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and other external agencies.
- Publish results of research projects as appropriate.
- Consider, review or develop pharmacoepidemiologic (quality of life, cost/effectiveness) and health economic aspects.
- Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications for clinical pharmacology-biopharmaceutical trials.
- Provide clinical reports for local and international regulatory purposes.
Regulatory Support Activities
- Support I assist in the preparation of regulatory reports, including the medical sections of the IND and Investigator Brochure, preparation of FDA advisory committee regulatory hearings and label discussions, and communications and resolution of regulatory issues, including regulatory response.
People Management and Development:
- Develop, and retain a scientifically excellent, innovation-minded, highly capable workforce with strong exploratory medicine experience
- Build an organizational culture that fosters inclusion and innovation, continual improvement, and with an external understanding and awareness
- Develop an organizational talent base that demonstrates judgment-based risk taking and decision making
Business customer support (pre and post launch support)
Basic Qualifications
Life science degree (MD, PhD, PharmD) with requisite experience in Clinical Pharmacology
Additional Skills/Preferences
PhD preferrable but not required
- Experience in Pharmaceutics and Product Design preferrable
- Knowledge of and experience in Clinical Pharmacology and drug development process preferred
- Fluent in English; both written and verbal communications
- Interpersonal, organizational and negotiation skills
- Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Excellent teamwork skills.
- Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
3-5 years of clinical experience or
3-5 years of pharmaceutical experience (2 of which is in clinical development)
- Have a BS or Masters degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience that is directly related to at least one of the following
OR
Clinical trial experience/Experience in areas relevant to drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
If experience is either in 2 and or 3 only (for example, no clinical trial experience), the following must be provided as supporting evidence of candidates ability/capability to perform in a CRS role
- Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content= medical, scientific or clinical information)
- Candidate's selection for CRS role must be endorsed by the BU Med affairs/development VP or equivalent area Senior leadership
o Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
o Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills
o Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
o Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
o Fluent in English, verbal and written communication
Target Pay Range for US: $135-138K
Physical Demands/Work Environment:
Work Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequent travel to clients/ site locations with occasional travel both domestic and international.
Physical Requirements:
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
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