Associate Director/Director Pharmaceutical Development

BridgeBio
California
Workplace: RemoteFull timeUSD 223,000 - 239,000 annuallyFunction: Executive & General ManagementExperience: 7+ yearsEducation: phdSkills: ["Cross-functional collaboration","Leadership","Communication","Quick learning","Stakeholder management"]

Serve as the CMC lead for pharmaceutical development, guiding cross-functional project teams with strategic expertise across formulations, manufacturing processes, and regulatory readiness. Develop and advance pediatric formulations and clinical supply capabilities, review CRO/vendor programs for quality and timeline compliance, and manage drug forecasts. Provide formulation and clinical supply support for US/EU regulatory submissions (e.g., IB/IND/NDA) while integrating closely with the CMC team.

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FursaFursa
BridgeBio
BridgeBio
1 week ago

Associate Director/Director Pharmaceutical Development

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Last checked: 4 hours agoStatus: Live

Job Summary

Serve as the CMC lead for pharmaceutical development, guiding cross-functional project teams with strategic expertise across formulations, manufacturing processes, and regulatory readiness. Develop and advance pediatric formulations and clinical supply capabilities, review CRO/vendor programs for quality and timeline compliance, and manage drug forecasts. Provide formulation and clinical supply support for US/EU regulatory submissions (e.g., IB/IND/NDA) while integrating closely with the CMC team.
Location: California
Workplace: Remote
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Provide strategic pharmaceutical development guidance as the CMC lead across cross-functional project teams.
  • •Develop robust formulations and manufacturing processes to support development and rapid registration of QED products.
  • •Review development and manufacturing programs at CROs/external vendors to ensure compliance with proposals, quality standards, and timelines.
  • •Manage drug forecasts and associated transactions.
  • •Support preparation of regulatory submissions (e.g., IB, IND, NDA) with formulation and clinical supply expertise.
Travel: High travel

Pay and Benefits

Salary: USD 223,000 - 239,000 annually
Equity and Bonus:Equity
Perks:401kHealth InsuranceDentalVisionHsaFsaEquityAnnual BonusPaid LeaveRemote Work

Key Requirements

  • •PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharmaceutical industry experience in formulation development and Clinical Supply.
  • •Expertise in formulation plus knowledge of PK/PD principles, ADME concepts, and regulatory documentation/authorship.
  • •Hands-on experience in clinical trials management/study conduct, formulation development, and clinical trial manufacturing.
  • •Demonstrated ability to manage Clinical Supply, formulation development, and manufacture at CROs.
  • •In-depth knowledge of CMC regulatory requirements for US and EU, including import/export sensitivities.
Experience:7+ yearsBiopharmaceuticalFormulation developmentClinical supplyClinical trialsCMCRegulatory submissions
Education:PhD / Doctorate in Chemistry or Pharmacy
Skills:Cross-functional collaborationLeadershipCommunicationQuick learningStakeholder management
Languages:English

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn