Senior Medical Director

BeiGene

4d•$299,800 - $369,800

About The Position

The Senior Medical Director, Hematology will support BeOne Clinical and Medical Hematology assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. As a leader in the organization, the incumbent will be involved in clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will play a key role in the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Requirements

6 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies
Advanced degree (MD or MD equivalent) with subspecialty training in hematology/oncology (preferred)
Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist role
Clinical oncology experience: candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology
Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing
High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
Knowledge of GCP and ICH Guidelines
Flexibility to work with colleagues in a global setting
Experience with the development and support of related SOPs and policies is expected
Knowledge of industry standard Clinical Development IT solutions expected

Nice To Haves

Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred

Responsibilities

Facilitate generation of, author, update, and/or review key documents, including, but not limited to: Protocol concepts, synopses, protocols, and amendments; Informed consent documents; Investigator Brochures; Clinical study reports; Abstracts, posters and manuscripts; Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports; Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports; Risks / benefits analysis for applicable documents; Clinical Development Plans
Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
Provide scientific expertise for selection of investigator and vendors
Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
Review, query, and analyze clinical trial data
Interpret, and present clinical trial data both internally and externally
Represent a clinical study or development program on one or more teams or sub teams
Create clinical study or program-related slide decks for internal and external use
Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
Contribute to or perform therapeutic area/indication research and competitor analysis
Build strong relationships with internal experts
Identify continuous process improvement opportunities.
Identify incremental organizational resource needs – staff, budget, and systems
Develop, track, execute and report on goals and objectives
Support budget planning and management
Be accountable for compliant business practices