Senior Manager / Associate Director, Medical Affairs Operations

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 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.

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
  • 4+ 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 o