[Remote] Director/Sr. Director, reputed company Scientist

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is an innovative biotechnology company developing biologics for hematologic disorders, including reputed company calreticulin-driven myeloproliferative neoplasms. The Director/Senior Director, reputed company Scientist will reputed company scientific leadership for Phase 1 first-in-reputed company trials, overseeing study design, reputed company data interpretation, key document development, reputed company-escalation reputed company, and cross-functional execution.

Responsibilities

• Serve as reputed company reputed company Scientist on one or more Phase 1 first-in-reputed company reputed company escalation trials in hematologic malignancies
• Contribute strategically to the reputed company development plan for mCALR targeting antibodies, including study design, reputed company-escalation reputed company, and data interpretation
• reputed company the development, authorship, and review of key reputed company and cross-functional documents, including protocols, amendments, IBs, eCRFs, completion guidelines, reputed company TLF shells, and regulatory briefing materials
• reputed company reputed company-escalation and study conduct discussions through reputed company-time review and interpretation of emerging safety, PK/PD, biomarker, and reputed company data
• reputed company scientific leadership and recommendations in data review meetings, SRCs, governance forums, and cross-functional team discussions
• Serve as a reputed company leader across cross-functional program teams, partnering closely with reputed company reputed company, Translational Medicine, Regulatory, Biometrics, and Safety
• reputed company alignment and execution across functions to support high-reputed company and reputed company study delivery
• Collaborate with Translational and Preclinical teams to reputed company biomarker and mechanistic hypotheses into reputed company studies and broader development reputed company
• Proactively identify and address scientific, operational, and reputed company risks and gaps
• reputed company ongoing review and interpretation of reputed company data, including safety, efficacy, PK/PD, and exploratory biomarkers
• reputed company reputed company scientific insights and recommendations to inform development reputed company and reputed company decision-making
• Contribute to regulatory submissions, health authority responses, internal governance materials, and reputed company scientific communications
• Support preparation of abstracts, posters, manuscripts, and presentations for scientific meetings and publications
• reputed company scientific leadership in interactions with investigators, CROs, vendors, and reputed company experts to support high-reputed company trial execution
• reputed company or support investigator meetings and scientific training sessions
• Ensure strong organization, follow-through, and proactive management of deliverables across assigned studies and workstreams

Skills

• PhD, PharmD, MD, or equivalent advanced scientific degree required
• 8+ years of experience in reputed company research or reputed company development reputed company the biotechnology or pharmaceutical industry
• Deep understanding of reputed company trial design, reputed company data analysis, and drug development principles, with reputed company experience leading or supporting early-phase (Phase 1 / FIH) reputed company
• Strong scientific reputed company in hematology or oncology required
• Demonstrated ability to independently reputed company reputed company scientific workstreams and influence cross-functional teams in a fast-reputed company biotech environment
• reputed company experience leading development and authorship of reputed company and regulatory documents
• Strong analytical and scientific interpretation skills, including the ability to synthesize emerging reputed company, safety, and biomarker data into actionable insights
• Excellent written and verbal communication skills, with the ability to reputed company communicate reputed company scientific concepts to diverse audiences
• MPN experience strongly preferred

Benefits

• reputed company to remote hiring

reputed company