The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies for Alpha-1-Antitrypsin Deficiency and will also provide medical support for ex-vivo base editing programs in hematology and oncology. 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.
- Serves as the Clinical Development lead on the cross-functional Program Team and 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.
- MD, DO or equivalent ex-US medical degree.
- Board certification/eligibility in pulmonary or hematology/oncology, or another relevant specialty highly desired.
- Minimum of 4 years of Pharmaceutical/Biotech industry experience in clinical development and medical monitoring.
- Strong oral and written communication skills to influence others.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- Clinical development and/or clinical experience in rare disease, cell & gene therapy is a plus.
- Ability to work independently to resolve challenges.