What are the responsibilities and job description for the Senior Medical Director, Clinical Development, Hematology position at Beam Therapeutics Inc.?
Company Overview :
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview :
The Senior Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies for hematology, specifically for sickle cell disease and beta-thalassemia, using novel conditioning and / or in vivo approaches. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions. Level will be commensurate with experience.
Responsibilities :
- Serves on cross-functional teams for assigned programs, working with other team members to drive program and clinical strategy in applicable populations and indications
- Co-lead the Clinical Development Sub-team for assigned programs, working with other team members to drive program and clinical strategy to registration in applicable populations and indications.
- Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP).
- Serves as the medical monitor for assigned studies including design, execution and interpretation study data.
- Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
- Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
- Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees / IRBs, and other documents as appropriate.
- Acts as liaison between Clinical Development and other internal groups at BEAM for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
- Establishes strong collaborations with study investigators, outside medical experts and represents BEAM during investigator meetings and advisory boards.
- Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas.
Qualifications :
