Director Clinical Scientist

Job Title: Director Clinical Scientist

Job Number: 84286

Location: Remote, US

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.

Application Deadline: 2024-11-04