Company: Confidential
Job Title: Director Clinical Scientist
Job Number: 35023
Location: Remote,
Job Description
Are you ready to make a significant impact in the treatment of pulmonary arterial hypertension (PAH)? Our biotech client is seeking a dedicated Global Clinical Scientist to join their Clinical Development team. In this crucial role, you will support the clinical development program, focusing on the conduct of a Phase 3 study in PAH.
Responsibilities
- Oversee the global Phase 3 PAH study in partnership with the Clinical Operations Co-lead.
- Support all aspects of the PAH Clinical Development program under the guidance of the Program Clinical Development Lead, including design, preparation, conduct, analysis, and reporting of clinical studies.
- Review and contribute to clinical and regulatory documents, such as clinical study reports and development plans.
- Participate in the authorship of clinical/regulatory documents, including investigator brochures, safety risk management plans, PIPs, and regulatory briefing packages.
- Ensure data quality by reviewing data listings.
- Foster strong relationships and communication among the clinical study/project team and the development organization.
- Represent Clinical Development in weekly meetings with clinical operations, CROs, and other stakeholders.
- Collaborate with other functional areas to support the clinical study and PAH program.
- Contribute to the clinical development plan for PAH, incorporating pre-clinical, clinical, regulatory, operational, biometric, CMC, and commercial strategies.
- Provide feedback on specific sites and regions to inform potential protocol amendments and identify accrual barriers.
- Maintain strong relationships with clinical investigators to support study enrollment and open communication.
- Lead contingency planning efforts, team problem solving, and drive effective decision-making.
- Contribute to the analysis and summary of clinical findings to support decisions on safety and efficacy, potentially serving as the primary author for certain documents.
- Conduct site visits with investigators and study staff to ensure high-quality study conduct.
- Support clinical development for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Required Skills
- Advanced Degree in Life Sciences (PhD, PharmD, or MS).
- 3-5+ years of experience in clinical science, clinical research, or equivalent.
- Therapeutic expertise in PAH, PH-ILD, idiopathic pulmonary fibrosis (IPF), or rare diseases.
- Broad knowledge of the drug development process, including early and late-phase development.
- Proficiency in data analysis and using Excel and PowerPoint.
- Experience leading Phase 2 and Phase 3 studies and study teams.
- Strong writing and editing skills for scientific and regulatory documents.
- Advanced analytical skills and proficiency in data interpretation.
- Experience conducting literature searches and synthesizing information.
- Expert understanding of global clinical study design and drug development processes.
- Strong understanding of GCP and ICH Guidelines.
- Excellent interpersonal skills; ability to work independently and collaboratively, exercise sound judgment, escalate issues when necessary, and motivate team members.
- Experience presenting at both internal and external meetings.
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