• Full Time (Salaried)
  • Remote,

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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