Senior Medical Director/Vice President, Clinical Development
QED Therapeutics, a subsidiary of BridgeBio Pharma, is a biotechnology company focused on precision medicine for FGFR-driven disorders. Our lead candidate is infigratinib, a best-in-class FGFR kinase inhibitor that has shown meaningful clinical activity in chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions. QED is also evaluating infigratinib in preclinical studies for the treatment of achondroplasia. We plan to develop infigratinib in additional FGFR-driven tumor types and rare disorders.
BridgeBio is a collection of individuals focused on discovering and developing drugs for patients with grievous genetic diseases. We do this by:
Finding the right starting points to target diseases at their source. Using a combination of a systematic assessment of the genetic disease landscape and informed diligence on the latest research, find indications with clear mechanisms of pathogenesis that are ripe for translation into disease-modifying drugs.
Building products with world-class R&D personnel. We employ over 50 scientists and work closely with leading academics to prosecute a wide variety of drug programs at the highest level of scientific rigor.
We combine biopharmaceutical veterans with up-and-coming leaders to drive entrepreneurial thinking grounded by experience
Employing a lean, capital efficient model. We house each effort in an individual subsidiary company supported by shared central resources. This efficient, de-centralized corporate structure enables focus at level of each disease, but provides diversification and the ability to scale across many opportunities.
Reporting to the CMO, this individual may be called upon to serve as clinical lead of an NDA submission and to plan, design, execute, and report on phase l through 3 clinical trials for infigratinib in cholangiocarcinoma, urothelial carcinoma, achondroplasia, and other disorders. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of QED’s clinical development plan. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within QED’s portfolio to ensure the program meets the needs of patients and QEDs business. This role will influence both internal and external audiences in a high impact, highly visible role as it actively contributes to the dynamic and innovative culture within QED.
Essential Skills & Functions:
- Serve as clinical lead of regulatory submission of infigratinib, including contributing to/overseeing authoring of clinical modules and clinical review of other modules
- Lead or assist in the synthesis of strategic clinical development plans and execute on same, including, for example managing or assisting with
- Regulatory briefing document preparation and review
- Scientific literature review and summarization
- Protocol & CRF development
- CRO selection medical monitoring
- CRO selection medical monitoring
- Medical data review
- Clinical study report writing
- Investigator brochure writing
- Assistance with writing and preparation of abstracts, presentations and manuscripts
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into clinical development opportunities
- Interact with clinical investigators and thought leaders
- Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Attend key scientific congresses and meetings as requested in support of speakers and key opinion leaders.
- Remain current in relevant therapeutic areas, and conversant with the literature as well as key emerging data.
- Remain current with FDA and international regulatory guidance relevant to oncology and orphan drug development, and participate in regulatory authority meetings as required
Preferred Education and Experience:
- Patient-focused, with deep commitment to understanding needs and improving the lives of patients and a passion for developing novel therapeutics
- Motivated to work in a fast-paced, high accountability, small company environment. A “can do” and collegial professional who leads through influence and interpersonal skills.
- Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
- Demonstrated ability to collaborate successfully with multiple functions in a team environment.
- Intellectually curious with courage to challenge and seek new ways to improve work
- Strong written and oral communication skills, including presentation skills.
- Ability to analyze and interpret data and develop written reports and presentations of those data
- Strong critical, strategic, and analytical thinking skills
- Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis and reporting.
- Experience in working closely with investigative sites, including principal investigators, sub- investigators, study coordinators and other site personnel involved in clinical trials.
- Experience with pivotal studies a must
- MD or equivalent with at least 5 years of international clinical development experience. Oncology experience is preferred.
- Board Eligible/Certified