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 Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• Bachelor’s degree
• Science background preferred (RN, PharmD, Master's degree), but not required
• Proven credentials in project management required
• 3-4 years of project and operations management experience, including at least 2 years in Biotech or Pharmaceutical industry, required
• At least 2 years of active working experience in Medical Affairs organizations and functions (including but not limited to HCP interactions, MSLs, content management, Sunshine Act Reporting, Agency Management, Contract management, KOL/HCP management) required
• Proficient in managing medical affairs operations systems, including Veeva CRM, Veeva Promomats, and document management systems
• Proficient in managing DocuSign, Concur, Coupa, and vendor management systems required
• Proficient in managing project management software such as Smartsheet, Wrike, or ClickUp required
• Knowledge of pharmaceutical regulations, regulatory compliance and quality assurance
• Able to manage department budgets, purchase orders (P.O.s), statements of work (SoWs), and payments on time and with quality required
• Ability to manage simultaneous priorities, changing deadlines, and limited resources required
• High sense of urgency, attention to detail, and commitment to execution required
• Great organizational and prioritization skills
• Excellent communication and interpersonal skills, highly organized, and detail-oriented required
• Advanced knowledge of Microsoft Office (Word, Access, Excel, PowerPoint, Teams) required
• Communicate to influence facts and logical approaches
• Self-reflective, problem-solving orientation, and agility to pivot with multiple concurrent projects. Within tight timelines in a fast-paced organization
• Proficient writer and verbal communicator in English required
• Ability to travel approximately 15% is required. International and overnight travel is required
• Must be able to work during Pacific Time Zone working hours
• Must be legally authorized to work in the United States

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time 
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.