Pharmacologist Jobs

About The Position

Requirements

• Life-science degree (MD, PhD, or PharmD) with requisite experience in Clinical Pharmacology.
• Three to five years of clinical experience or three to five years of pharmaceutical experience, including two years in clinical development.
• Alternatively, a BS or master’s degree in a health, medical, scientific, or related field and 7–10 years of directly related pharmaceutical experience, together with experience in relevant areas such as clinical trials, drug discovery, drug or clinical development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs.
• For candidates whose experience is limited to drug/clinical development or other relevant areas without clinical-trial experience, evidence of the candidate’s direct role and contribution to medical content is required, including ownership or oversight as creator, reviewer, or approver; selection must be endorsed by the relevant Business Unit Medical Affairs/Development VP or equivalent senior leader.
• Demonstrated ability to balance scientific and business priorities, with examples of successful leadership.
• Strong communication, interpersonal, teamwork, organizational, and negotiation skills.
• Ability to influence others across and within functions to create a positive working environment.
• Fluent written and verbal English communication.
• Ability and willingness to travel domestically and internationally as appropriate to support the team’s business.
• Ability to sit for extended periods and operate a vehicle safely.
• Ability to make fast, simple, repeated movements with the fingers, hands, and wrists.
• Ability to crouch or stoop occasionally and bend and twist the upper body and neck frequently.
• Ability to access and use varied in-house and off-the-shelf computer software.
• Ability to lift and carry light to moderate items, including luggage and a laptop, up to 15–20 pounds.
• Regular and consistent attendance; varied hours may be required.

Nice To Haves

• PhD preferred, but not required.
• Experience in Pharmaceutics and Product Design preferred.
• Knowledge of and experience in Clinical Pharmacology and the drug development process preferred.

Responsibilities

• Contribute to the overall clinical development strategy and plans for compounds, emphasizing studies needed for product decisions or regulatory submissions.
• Support high-level Phase 2 and Phase 3 study plans and detailed biopharmaceutics plans for submissions.
• Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics, and other quantitative-science functions on study methods and integration with disease-progression and drug-response models.
• Contribute to global Phase I and II clinical studies and submission-planning activities.
• Work with discovery research scientists on basic research strategies, clinical candidate selection, and preclinical development.
• Partner with Brand Team and Business Unit colleagues on market differentiation and regulatory support for biopharmaceutics submission plans.
• Design and oversee clinical pharmacology studies, including studies involving healthy volunteers, patients, and special populations.
• Design and oversee methods for development and biomarker qualification studies.
• Create and oversee study protocols and support study-conduct documentation in collaboration with functional areas, operations staff, and affiliates.
• Collaborate with clinical research staff, statisticians, health outcomes researchers, consultants, and investigators on protocols and data-collection requirements.
• Participate in investigator identification and selection with the clinical pharmacology sourcing group.
• Review risk profiles and local informed-consent documents, ensuring appropriate communication of risk to study subjects.
• Ensure operational teams document administrative requirements for study initiation and conduct, including ethics review, informed consent, and regulatory approvals or notifications.
• Participate in study start-up meetings and provide training and information to investigators and site personnel.
• Advise clinical trial managers, monitors, investigators, and ethics review boards on scientific questions and issues arising during studies.
• Address investigators’ and study personnel’s scientific information needs.
• Monitor patient safety, track and follow up adverse events, and implement and communicate pharmacovigilance actions in collaboration with Global Patient Safety.
• Provide oversight and partner with Third Party Organizations to support successful study execution.
• Comply with laws, regulations, and policies governing scientific data dissemination and interactions with external healthcare professionals and customers.
• Respond to unsolicited scientific questions from external healthcare professionals in accordance with applicable guidelines.
• Participate in clinical trial registry reporting, publication strategy, data analysis, scientific data dissemination, and preparation of final trial reports and publications.
• Prepare and present clinical-trial results to corporate committees, regulatory agencies, and other external agencies; publish research results as appropriate.
• Consider, review, or develop pharmacoepidemiologic and health-economic aspects, including quality-of-life and cost-effectiveness considerations.
• Support planning of symposia, advisory board meetings, and other meetings with healthcare professionals.
• Provide clinical reports for local and international regulatory purposes.
• Assist with regulatory reports, including medical sections of INDs and Investigator Brochures, FDA advisory committee materials, label discussions, and regulatory communications and responses.
• Support business customers before and after product launch.
• Develop and retain a scientifically excellent, capable workforce; foster inclusion, innovation, continual improvement, and external awareness; and develop organizational talent in judgment-based risk-taking and decision-making.
• Participate in executive and governance presentations, external key opinion leader interactions, medical outreach or advocacy, and industry conferences as needed.