I am currently partnered with an innovative biotech company advancing therapies in hematologic malignancies. As we prepare to initiate a global Phase 3 pivotal study inmyelofibrosis, we are seeking an experiencedMedical Directoron a contract basis to provide strategic medical leadership and clinical oversight throughout this critical development phase.
Position Summary
The Medical Director will play a key role in the planning, execution, and medical oversight of the Phase 3 trial. This position requires expertise in hematology, ideally with direct experience in myelofibrosis or related myeloproliferative neoplasms. The successful candidate will work cross-functionally with clinical operations, regulatory, pharmacovigilance, and external partners to ensure the trial's success.
Key Responsibilities
Provide medical and scientific leadership for the design, execution, and reporting of the Phase 3 myelofibrosis trial.
Serve as the primary medical contact for internal teams, investigators, and external stakeholders.
Oversee patient safety and ensure compliance with ICH-GCP, FDA, and EMA regulations.
Support clinical data analysis, review, and interpretation; contribute to regulatory submissions and clinical study reports.
Engage with key opinion leaders (KOLs) in hematology to inform trial strategy and execution.
Collaborate with the CRO and site investigators to ensure high-quality data collection and protocol adherence.
Qualifications
MD or equivalent with board certification in hematology or oncology preferred.
Significant experience (10 years) in clinical development, with a strong focus on late-stage trials in hematology.
Prior involvement in Phase 3 studies; experience inmyelofibrosisormyeloproliferative neoplasmsis highly desirable.
Proven ability to manage cross-functional clinical teams and interact effectively with CROs and regulators.
Strong analytical, strategic thinking, and communication skills.
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