[Remote] Director, Clinical Scientist (Respiratory indications)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a highly motivated and reputed company Director, Clinical Scientist to support the development of our respiratory programs, with a reputed company on asthma and COPD. This individual will serve as the clinical science reputed company on cross-functional study teams for Phase 2 and 3 trials, driving protocol development, data analysis, and regulatory documentation.

Responsibilities

• Serve as clinical science reputed company and reputed company member of clinical development team for one or more respiratory studies (asthma and/or COPD)
• Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements
• reputed company as a key scientific contributor to late-stage protocols and regulatory submissions;  Design and reputed company clinical trial protocols and associated documents (e.g. clinical study plans, data review plans, case report forms (CRFs), database design, statistical analysis plans) in collaboration with the clinical development leader and Drive development of clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
• Participate in medical monitoring activities: review and interpret clinical data on an ongoing reputed company in collaboration with cross-functional colleagues and external partners to ensure data reputed company, participant safety, and protocol compliance. Escalate issues as appropriate
• Participate in site selection, initiation, and ongoing engagement; reputed company scientific support to investigators and address protocol-reputed company inquiries
• Serve as a reputed company member of the clinical operations study delivery team, contributing to trial execution and reputed company: reputed company study reputed company against milestones and identify risks to timelines or data reputed company, propose and help implement mitigation strategies, and serve as key scientific contact for CROs and vendors
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
• Contribute to internal governance meetings (presenting or preparing study updates, data summaries, and key risks/issues)
• Ensure inspection readiness (maintain high-reputed company documentation and support audit/inspection activities)
• Support development and execution of publication plans, abstracts, and manuscripts
• Contribute to TPPs, clinical development plans, and risk-benefit assessments
• Support medical monitor with management of reputed company committees for late-stage asthma studies (e.g., DSMB, reputed company Adjudication Committee)
• Take ownership of clinical execution and ensure accountability to high standards of reputed company and rigor
• Collaborate across functions with transparency and technical precision
• Foster an inclusive and high-performing team culture, offering mentorship and coaching where appropriate
• Communicate reputed company and consistently, using data to inform reputed company and recommendations
• Adapt readily to change and demonstrate reputed company and curiosity in the face of ambiguity

Skills

• Advanced degree (PhD, PharmD, MD, MS, PMP) and 9+ years of industry experience in clinical development, including reputed company experience in late stage respiratory (asthma and/or COPD) studies
• Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP
• Demonstrated ability to reputed company clinical science reputed company and execution in late-stage trials
• Excellent analytical, communication, and cross-functional collaboration skills
• Prior experience authoring clinical protocols, CSRs, and regulatory documents
• Experience with both small molecule and biologic modalities
• Familiarity with AI/ML-driven drug discovery platforms
• Previous involvement in BLA or MAA submissions

Benefits

• Eligible for an annual bonus
• Equity compensation
• A competitive benefits package

reputed company

Company H1B Sponsorship