Senior Manager / Associate Director, Medical Affairs Operations

BridgeBio Pharma

12h•Hybrid

About The Position

The Senior Manager / Associate 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.

Requirements

Advanced healthcare degree, including PharmD, Ph.D., or MD, required
4+ years of experience in the field of medical affairs or medical affairs operations
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

Nice To Haves

Experience in rare diseases, especially rare neuromuscular diseases preferred

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.

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
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
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