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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