Director, Medical Affairs Operations at BridgeBio Pharma

, , United States -

Full Time

Start Date

Immediate

Expiry Date

27 Mar, 26

Salary

260220.0

Posted On

27 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Operations Management, Medical Affairs, Regulatory Compliance, Quality Assurance, Budget Management, Communication, Interpersonal Skills, Organizational Skills, Attention to Detail, Microsoft Office, Veeva CRM, DocuSign, Vendor Management, Networking, Scientific Dialogue

Industry

Biotechnology Research

Description

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. What You'll Do The Director, Medical Affairs Operations, will play a key cross-functional role supporting the development, coordination, and execution of strategic medical initiatives across medical affairs for ML Bio Solutions (ML Bio), a BridgeBio company. ML Bio is developing BBP-418, potentially the first oral treatment for patients with Limb Girdle Muscular Dystrophy type 2I/R9 (FKRP-related) (LGMD2I/R9). This individual will serve as a core liaison between external vendors/stakeholders, field medical teams, and internal stakeholders, driving medical insights and execution excellence to support the organization’s strategic goals. The successful candidate will have an opportunity to design and manage the Medical Affairs Group’s Operational infrastructure. In addition, this individual will support other key medical affairs activities, such as driving all grants, IITs, and sponsorships and being the key medical member of the medical/regulatory/legal (MRL) review committee. Responsibilities Be the medical member of the medical/regulatory/legal (MRL) review committee 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 Manage and own provide operational and functional aspects of congresses, advisory boards, complex meeting planning and execution. 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 Lead and drive medical affairs in identifying potential investigators and research projects, grants, investigator-sponsored trials (IITs), sponsored study site identification, etc. Where You'll Work This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office. Who You Are Advanced healthcare degree, including PharmD, Ph.D., or MD, required Relevant Experience 7+ years of experience in the field of medical affairs or medical affairs operations Experience in rare diseases, especially rare neuromuscular diseases preferred Skills 3+ years of project and operations management experience, including at least 3 years in Biotech or Pharmaceutical industry, required At least 3 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 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 (including networking) highly organized, and detail-oriented required Advanced knowledge of Microsoft Office (Word, Access, Excel, PowerPoint, Teams) required Communicate to influence facts and logical approaches Able to participate in a scientific dialogue with KOLs and researchers Travel – 20% time used for travel Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary $229,430—$260,220 USD

Responsibilities

The Director will support the development and execution of strategic medical initiatives across medical affairs. They will serve as a liaison between external vendors, field medical teams, and internal stakeholders.