BridgeBio

Director, Medical Affairs Operations

BridgeBio

full-time

Posted on:

Location Type: Hybrid

Location: 🇺🇸 United States

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Salary

💰 $229,430 - $260,220 per year

Job Level

Lead

About the role

  • Play a key cross-functional role supporting the development, coordination, and execution of strategic medical initiatives across medical affairs
  • Serve as a core liaison between external vendors/stakeholders, field medical teams, and internal stakeholders
  • Drive medical insights and execution excellence to support the organization’s strategic goals
  • Design and manage the Medical Affairs Group’s Operational infrastructure
  • Support other key medical affairs activities, such as driving all grants, IITs, and sponsorships
  • 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
  • Develop and maintain a calendar of meetings across programs, including congress and internal meetings
  • Liaise with HCPs, and Legal and Contracts 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.

Requirements

  • Advanced healthcare degree, including PharmD, Ph.D., or MD, required
  • 7+ years of experience in the field of medical affairs or medical affairs operations
  • Experience in rare diseases, especially rare neuromuscular diseases preferred
  • 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
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
project managementmedical affairs operationscontent managementregulatory compliancequality assurancebudget managementvendor managementscientific dialoguegrant managementinvestigator-sponsored trials
Soft skills
organizational skillsprioritization skillscommunication skillsinterpersonal skillsattention to detailsense of urgencyability to manage prioritiescommitment to executionnetworking skillsadaptability
Certifications
PharmDPh.D.MD