FSP Clinical Pharmacologist - Neurology/Immuno Oncology & Metabolic

Fortrea•Durham, CA

6d•$135,000 - $138,000•Remote

About The Position

The Clinical Pharmacologist (CP) applies pharmacological training, expertise, and therapeutic-area experience to support the development, conduct, and reporting of global clinical trials for new compounds. The role contributes to clinical pharmacology strategy and plans, clinical trial implementation, safety reporting, review of protocols and study reports, publications and data dissemination, product labeling, regulatory submissions, and interactions with regulatory agencies and external clinical customers. The CP also works with research scientists on lead-compound selection and preclinical studies, partners with business teams on clinical pharmacology submission planning, and serves as a scientific resource to study teams and other groups. The CP ensures that medical-team activities comply with applicable local and international laws, regulations, guidance, Good Clinical Practices, company standards, policies, procedures, and principles of medical research, and align with the medical vision. The position may also support executive and governance presentations, key opinion leader interactions, medical outreach and advocacy, and industry conferences. Responsibilities span clinical planning; design and oversight of clinical pharmacology and biomarker studies; trial execution and patient-safety monitoring; scientific data analysis, reporting, and dissemination; regulatory support; people management and development; and pre- and post-launch business customer support. The primary focus is clinical pharmacology, including early-phase exploratory and late-phase biopharm submission studies. The role is listed as remote in the United States. Work is performed in an office environment with exposure to electrical office equipment, and frequent travel to client or site locations is expected, with occasional domestic and international travel. Varied hours may be required.

Requirements

Life-science degree (MD, PhD, or PharmD) with requisite experience in clinical pharmacology.
Fluency in written and spoken English.
Strong interpersonal, organizational, and negotiation skills.
Ability to influence others across and within functions to create a positive working environment.
Excellent teamwork skills.
Willingness and ability to travel domestically and internationally as appropriate to support the team.
The posting lists 3–5 years of clinical experience or 3–5 years of pharmaceutical experience, including 2 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, such as clinical trials, drug discovery or development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs.
For candidates whose experience is limited to the latter listed experience areas without clinical trial experience, the posting requires documented evidence of a direct role and contribution to medical content, including ownership or oversight as creator, reviewer, and approver.
For candidates in that experience circumstance, selection for the CRS role must be endorsed by the business unit medical affairs/development VP or equivalent senior leadership.
Ability to balance scientific and business priorities, supported by examples of successful leadership.
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills.
Demonstrated ability to influence others across and within functions to foster a positive working environment.

Nice To Haves

PhD (preferred but not required).
Experience in pharmaceutics and product design.
Knowledge of and experience in clinical pharmacology and the drug development process.

Responsibilities

Contribute to overall clinical development strategy and plans, focusing on studies needed for product decisions or regulatory submissions.
Support high-level Phase 2 and Phase 3 plans and detailed biopharm plans for submissions.
Collaborate with patient safety, PK/PD, ADME, statistics, tailored therapeutics, and other quantitative science teams on study methods and integrated development plans.
Contribute to global Phase I and II clinical studies and submission planning.
Work with discovery research scientists on research strategies, clinical candidate selection, and preclinical development.
Partner with brand and business unit colleagues on market differentiation and regulatory support for biopharm submissions.
Design clinical pharmacology studies and oversee their implementation, including studies in healthy volunteers, patients, and special populations.
Design and oversee methods for development and biomarker qualification studies.
Develop and oversee clinical study protocols and related study documents in collaboration with functional teams, 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.
Review risk profiles and informed-consent documents and ensure appropriate risk communication to study subjects.
Oversee documentation of administrative and regulatory 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.
Serve as a resource to trial managers, monitors, investigators, and ethics review boards during study conduct.
Address scientific information needs of investigators and study personnel.
Monitor patient safety and track and follow up on adverse events in accordance with global policies and procedures.
Implement and communicate pharmacovigilance actions with global patient safety.
Provide oversight and partner with third-party organizations to support successful study execution.
Comply with laws, regulations, and policies governing 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 planning, and scientific communications.
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 symposia, advisory boards, and other meetings with healthcare professionals.
Participate in data analysis and prepare final reports and publications for clinical pharmacology and biopharm trials.
Prepare clinical reports for local and international regulatory purposes.
Support preparation of regulatory reports, including medical sections of INDs and Investigator Brochures, FDA advisory committee materials, label discussions, and regulatory responses.
Develop and retain a scientifically excellent, innovation-minded workforce with exploratory medicine experience.
Foster an inclusive, innovative culture of continual improvement and external awareness, and develop talent capable of sound risk-taking and decision-making.
Support business customers before and after launch.