Manager/Sr. Manager, Medical Affairs Operations

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://www.qedtx.com/ | https://bridgebio.com 

Who You Are

The Manager/Sr. Manager, Medical Affairs Operations will be responsible for the project management, daily operation, and support across a variety of critical initiatives for the Medical Affairs organization in preparation to the launch preparation activities of infigratinib, QED’s phase 3 leading asset. The successful candidate will have an opportunity to design and manage the Company’s Medical Affairs Group’s Operational infrastructure.  This role reports directly to the Head of Medical Affairs and offers a unique opportunity to work cross-functionally with internal and external stakeholders and will be a key member of the Medical Affairs Management Team (MALT). You will directly contribute to the overall success of the organization.  

Responsibilities

• Provide project management support to the Medical Affairs organization in alignment with its objectives and strategies
• Own, manage, oversee and update the library of MSL training material, standard response letters, medical presentation material, contracts, publications and other materials
• Expert in generating reports, trackers, timelines, and PowerPoint Presentations
• Member and administrator of the Grants & Sponsorships review Committee, Investigator Initiated Study Review Committee, Medical Affairs Leadership Team, Medical Affairs Annual Plan
• Excels at moderating meetings, taking precise minutes, and driving action. They must effectively manage complex meetings with senior stakeholders, ensuring discussions stay focused and concise
• Maintain content and have oversight into Medical Affairs SharePoint databases including contracts, medical resources
• Manage and own provide operational and functional aspects of congresses, advisory boards, complex meeting planning and execution
• Ensure the successful completion of deliverables and submission for medical/regulatory/legal (MRL) review committee
• Ensure that timelines, initiatives and resources align with Home Office Medical Affairs and Field MSL objectives, including congress planning and medical booth support 
• Develop and maintain a calendar of meetings across programs, including congress and internal meetings 
• Liaise with HCPs, and Legal and Contacts teams by submitting and tracking Medical Affairs contracts for timely submission and full execution 
• Coordinate the development of Standard Operating Procedures (SOPs) and compliance updates on an as-needed basis

No matter your role at BridgeBio, successful team members are:

• Patient Ch