Clinical Pharmacologist – Neurology, Immuno Oncology, Metabolic

This is a fully remote position, open to applicants in United States.

📋 Description

• Contribute to the development, execution, and reporting of global clinical trials for novel compounds.

• Execute global clinical trials and document adverse events in compliance with patient safety standards.

• Evaluate protocols, study reports, publications, data dissemination materials, labels, grant proposals, and contracts.

• Interact with regulatory and governmental bodies as well as external clinical partners, including thought leaders.

• Collaborate with basic research scientists to pinpoint lead compounds and strategize preclinical studies.

• Assist in the planning of clinical pharmacology submission packages alongside Business Unit teams.

• Act as a scientific resource for study teams and departments.

• Ensure that medical team activities adhere to relevant regulations, GCP standards, company policies, and procedures.

• Formulate clinical strategies and plans for compounds, encompassing Phase 2 and 3 as well as biopharm submission plans.

• Partner with Global Patient Safety, PK/PD, ADME, Statistics, and Tailored Therapeutics teams.

• Design and supervise clinical pharmacology, biomarker qualification, and clinical research studies.

• Create protocols and documents for study execution.

• Aid in investigator selection, study initiation, training, and site operations.

• Offer scientific assistance to trial managers, monitors, investigators, and ethics boards.

• Track patient safety and coordinate pharmacovigilance measures.

• Oversee third-party organizations that support study implementation.

• Address scientific inquiries from external healthcare professionals.

• Engage in clinical trial registry activities, data analysis, final reports, and publications.

• Present clinical trial outcomes to corporate committees, regulatory agencies, and external organizations.

• Facilitate publication strategies, symposia, advisory boards, and meetings with healthcare professionals.

• Prepare clinical reports and regulatory documents, including IND and Investigator Brochure medical sections.

• Support FDA advisory committee hearings, label discussions, and resolution of regulatory issues.

• Cultivate scientifically proficient and innovative teams and organizational talent.

• Provide pre- and post-launch business customer support.

⛳️ Requirements

• Degree in life sciences (MD, PhD, PharmD) with relevant experience in Clinical Pharmacology.

• PhD is preferred but not mandatory.

• Background in Pharmaceutics and Product Design is preferable.

• Familiarity with and experience in Clinical Pharmacology and the drug development process is advantageous.

• Proficient in English, both written and spoken.

• Strong interpersonal, organizational, and negotiation abilities.

• Capability to influence others across functions and within the role.

• Exceptional teamwork skills.

• Willingness to travel domestically and internationally.

• 3–5 years of clinical experience, or 3–5 years in the pharmaceutical industry, including 2 years in clinical development.

• Alternatively, a BS or Master's degree in a health, medical, scientific, or related field with 7–10 years of relevant pharmaceutical experience.

• Experience in clinical trials or in areas pertinent to drug discovery, drug/clinical development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs.

• Demonstrated contribution to medical content, where applicable.

• Proven ability to balance scientific and business priorities.

• Strong communication, interpersonal, teamwork, organizational, and negotiation skills.

• Regular and consistent attendance is required.

• Ability to sit for extended periods and operate a vehicle safely.

• Proficient in using various software applications.

• Capability to perform light to moderate lifting and carrying of up to 15–20 lbs.

• Flexibility in work hours may be necessary.

🏝️ Benefits

• Option for remote work.

• Opportunities for domestic and international travel.

• Support for EEO and accommodations.