Vice President, Clinical Development

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CoA Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical stage biopharmaceutical company developing novel therapies for difficult to treat and rare genetic disorders by harnessing advances in understanding of the CoA pathway. CoA’s team of veteran biotechnology executives are partnering with patients and physicians to bring forth effective therapies for PKAN, organic acidemias and other diseases as quickly as possible.

To learn more, visit us at https://coatherapeutics.com

Location

San Francisco, CA

Who you are

The CoA Therapeutics VP of Clinical Development has primary responsibility to lead the clinical development of the BBP-671 programs in PKAN, organic acidemias and any other indications. In addition to driving successful advancement of BBP-671, the role includes being more broadly a thought partner with the leadership team for rare disease development strategies. 

Responsibilities

  • Lead the clinical development program for BBP-671 by synthesizing and executing the strategic clinical development plans as outlined below:
    • Drive development and refinement of the clinical development plans (CDPs) for all indications, integrating clinical, pre-clinical, CMC, regulatory and corporate strategy.
    • Ensure excellence in both strategy and execution of the clinical programs by working closely with internal and external partners in clinical operations, project management, biostatistics, data management, regulatory affairs, nonclinical, CMC, medical writing, and others.
    • Work to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development.
    • Provide leadership to the clinical team by heading internal clinical team meetings as well as other meetings as appropriate
    • Advance the clinical programs by managing, performing and/or contributing to the following: 
      • Regulatory document preparation and review (e.g. briefing documents, applications for special designations, PIP, IND and BLA submissions)
      • Scientific literature review and summarization
      • Protocol & CRF development
      • Medical monitoring of clinical trials including ongoing safety monitoring
      • As appropriate, DSMC member selection, charter development, and preparation and conduct of meetings for specified periodic data reviews, dose escalation, dose selection, study expansion and ad hoc review of serious adverse events
      • Investigator meeting preparation and presentations
      • Clinical trial data review including internal summary presentations as required
      • Regulatory safety reporting (serious AEs and periodic safety updates)
      • Clinical study report writing
      • Investigator brochure writing
      • Assistance with writing and preparation of abstracts, presentations and manuscripts
    • Develop contingency plans for clinical development activities as needed, provide technical and strategic advice, and meet milestones and budgets
  • General Clinical Science Responsibilities and Expertise
    • Conduct clinical trials using quality (GCP) and ethical standards relevant to the pharmaceutical industry, and ensure compliance with these standards
    • Implement and abide by CoA Therapeutics and BridgeBio clinical R&D policies, SOPs and related directives.
    • Remain current in relevant scientific areas and conversant with the literature as well as key emerging data
    • Remain current with FDA and international regulatory guidance relevant to rare disease drug development; participate in regulatory authority meetings as required
  • External engagement
    • Build and grow relationships with clinical investigators and thought leaders; serve as first-line medical and scientific point of engagement for BBP-671 program
    • Collaborate with cross-functional colleagues to develop and execute BBP-671 publication plans; serve as internal lead for all clinical-stage publications and presentations
    • Attend and present at key scientific congresses and meetings; represent CoA/Therapeutics on invited panels; serve as the external face of the BBP-671 program wherever needed
    • In collaboration with patient advocacy colleagues, build and grow relationships with advocacy groups, support/collaborate on advocacy activities
    • In collaboration with cross-functional colleagues including those across BridgeBio affiliates, contribute to collaborative initiatives for innovation in rare disease drug development

Education, Experience & Skills Requirements

  • At least 5 years of experience in Clinical Research and/or Drug Development in Pharmaceutical or Biotechnology company/ies;
  • Experience in design, execution, and monitoring of clinical trials is required
  • Experience in developing investigational therapies for rare disease is desired as is experience with/comfort in translational drug development
  • Medical Degree; MD, PhD ideal
  • Patient/caregiver-focused, with deep commitment to understanding and supporting the needs and improving the lives of those touched by rare disease; passionate about developing novel therapeutics
  • Motivated to work in a fast-paced, highly accountable, small company environment. A collegial professional who leads through influence and interpersonal skills
  • Capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail
  • Demonstrated ability to collaborate successfully with multiple functions in a team environment
  • Strong written and oral communication skills, including presentation skills
  • Ability to analyze and interpret data and develop written reports and presentations of those data
  • Strong critical, strategic, and analytical thinking skills
  • Flexible and nimble; open to new ideas and adaptable to rapidly changing circumstances

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
careers

Vice President, Clinical Development

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