Associate Medical Director/Medical Director

Location
San Francisco, CA, United States
Posted
Sep 21, 2020
Ref
139159912
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Who You Are

Navire is looking for a talented and highly motivated Associate Medical Director/Medical Director to own the planning, implementation and daily operation of drug development projects. This position will collaborate with key internal and external stakeholders to support company initiatives that improve the quality and content of all clinical programs to deliver our portfolio.

Responsibilities:
  • Responsible for delivery of development projects
  • Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development
  • Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan
  • Present and defend protocols and clinical development plans at internal governance forums
  • Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations
  • Monitor study progress ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team
  • Present study updates, interim results, and final headline data to senior management as required
  • Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy)
  • Ensure that Serious Adverse Events are properly reported on a global basis
  • Implement clinical R&D policies, SOPs and related directives
  • Review potential in-licensing candidates and present recommendations to Senior Management groups
  • Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities

Education, Experience & Skills Requirements
  • MD required; PhD preferred
  • Medically licensed
  • Fellowship and/or board certification preferred
  • 3+ years of relevant experience as a Medical Director in biotech or pharmaceutical industry
  • Oncology experience required
  • Phase 1 clinical trial experience required
  • Ability to work in a small company with a largely virtual environment; startup experience preferred
  • Ability to manage complexity and uncertainty
  • Strong team interaction and communication skills
  • Embraces the company core values: 1. put patients first; 2. think independently, 3. be radically transparent; 4. every minute counts; and 5. let science speak

What We Offer
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion - with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so