Only 24h Left Clinical Research Physician
7 hours ago
Clinical Research Physician (CRP) and Head Safety Physician
Our client, a global pharma company, is currently recruiting for a Clinical Research Physician (CRP) and Head Safety Physician to join their team on a permanent basis. As Clinical Research Physician (CRP) and Head Safety Physician, you will be responsible for the overarching medical strategy and medical oversight for multiple assets in the organization's portfolio, across therapeutic areas and modalities, and be accountable for coordination of physician safety support across the portfolio. You will provide leadership in early phase clinical development on multiple exciting programs, working with external biotechs and venture capital funds, as well as internal therapeutic area experts; and the opportunity to gain skills across both clinical research and drug safety.
Responsibilities:
- Responsible for the medical and safety leadership for all phases of drug development from candidate selection to proof-of-concept readout.
- Work with a multidisciplinary team to construct and execute a sound clinical development plan to develop and test key scientific hypotheses, discharge risks regarding asset safety and efficacy, and enable effective decision-making related to asset development.
- Partner with the Asset Manager (AM) and the Clinical Research Consultant (CRC) for operational execution of all clinical studies, and with the Toxicology lead for First-in-Human (FIH) assets.
- Author, review and approve key documents, including protocols, risk profiles, informed consent documents, clinical study reports, and disclosure of research results.
- Responsible for leadership and oversight of medical safety matters, closely liaising with vendors, regulatory, safety, and study/project teams.
- Develop understanding of the disease process, patient attributes, concomitant medication usage, and other therapeutic issues in a wide variety of therapeutic areas.
- Critically read and evaluate the relevant medical and scientific literature; know the status and data from relevant competitive assets.
- Network with internal experts and external thought leaders to maintain awareness of current trends and projections for clinical research, practice, and access in the therapeutic area(s) relevant to the product.
- Provide medical leadership for clinical plans including appropriate strategic objectives, study population, dose range justification, biomarkers and study endpoints, assessment of safety, drug-drug interactions, and critical success factors.
- Provide scientific content to critical documents with primary accountability for risk/benefit assessment, patient safety, and observing the principles of GCP.
- Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and responses to regulatory questions.
- Author relevant protocol sections, and review and approve protocols.
- Contribute to informed consent documents, clinical study reports, publications, and other disclosures of research results.
- Provide clinical and strategic leadership to study teams for benefit: risk assessment language across the portfolio.
- Provide medical leadership in early development study conduct including study design, protocol writing, regulatory documents, CRO interactions, study start-up, investigator interactions, data monitoring, health authority interactions, analyses, and study reports.
- Serve as a medical monitor and safety physician for ongoing trials.
- Provide oversight and assistance in managing medical questions from investigator sites.
- Lead dose-escalation meetings and trial-level safety reviews (TLSR’s).
- Provide safety oversight as detailed below.
Requirements:
- Medical Doctor with experience in clinical trials management within the pharmaceutical industry.
- Experience in drug safety as a drug safety physician / global safety officer is strongly preferred, but other pharmacovigilance experience will be considered.
- Experience in immunology, oncology, and/or metabolic/endocrine disease areas a plus.
- Knowledge and experience in conducting development activities in compliance with all local laws and regulations and ICH guidelines.
- Strong knowledge of GVP and experience in case management, signal detection, benefit:risk assessment.
- Possess a good understanding of clinical pharmacology.
- At least 3 years experience directly in the pharmaceutical industry and at least 5 total years in the industry or adjacent activities which must include experience in drug safety.
- Hands-on experience of clinical trial execution as an investigator or sub-investigator.
- Experience in the management of medical safety in the context of clinical trials.
- Track record of contribution to clinical trial protocols and/or study conduct.
- Strong computer skills; Word, Excel, PowerPoint, Teams and SharePoint.
- Experience presenting data to varied stakeholders.
- Proactive self-starter, with excellent time management and organizational skills and ability to prioritize.
- Strong problem-solving skills.
- Strong leadership and interpersonal skills.
- Ability to represent the organization to key external stakeholders.
For more information please contact Sinéad Cullen on +353879500821 or sinead.cullen@lifescience.ie.
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