Medical Director/Senior Medical Director, Clinical Development, Genetic Diseases

• Serves as the Clinical Development lead on the cross-functional Program Team and co-lead the Clinical Development Sub-team for assigned programs
• 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
• 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 with 15+ years experience
• Minimum of 4 years of Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
• Board certification/eligibility in endocrinology or metabolic disorders, or another relevant specialty highly desired
• 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

Clinical development and/or clinical experience in rare disease, cell & gene therapy is a plus