Director of Bioanalytical Development, Stealth Company jobs in United States
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Third Rock Ventures ยท 15 hours ago

Director of Bioanalytical Development, Stealth Company

Third Rock Ventures is a fast-growing biotechnology company developing innovative antibody-based therapeutics. They are seeking a Director of Bioanalytical Development to lead strategy and execution for bioanalytical sciences, manage CRO partnerships, and ensure high-quality data for regulatory submissions.

BiotechnologyHealth CareMedical Device
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H1B Sponsor Likelynote
Hiring Manager
Tracy Nicholson
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Responsibilities

Define and implement bioanalytical strategies and ensure alignment with pipeline priorities and business needs
Serve as the subject matter expert guiding assay design, method development, and data interpretation
Champion the adoption of cutting-edge technologies and methodologies in bioanalysis
Identify, validate, and select CROs and external partners for bioanalytical studies
Oversee CRO activities to ensure compliance with timelines, budgets, quality standards and efficient data transfer
Build strong relationships with external partners and monitor performance metrics
Ensure the timely delivery of high-quality, scientifically sound bioanalytical data and oversee the integration of complex datasets
Guarantee all bioanalytical studies and operations comply with global regulatory standards
Design, validate and implement bioanalytical assays supporting PK, PD, ADA and biomarker assays for preclinical studies
Author and review regulatory documents and reports, such as those for IND filings
Work across functions to align bioanalytical strategies with program goals
Provide scientific input to project teams and contribute to key program decisions

Qualification

Bioanalytical strategyCRO managementRegulatory submissionsBiomarkers expertiseGLP requirementsPharmacology Ph.D.CommunicationLeadership skillsCross-functional collaboration

Required

Ph.D. or equivalent in Pharmacology, Biochemistry, Immunology, or related discipline
10+ years of experience in bioanalytical sciences within biotech or biopharma, with a focus on biologics or antibodies
Proven expertise in biomarkers, PK/PD, and translational science
Strong understanding of GLP requirements and regulatory expectations for IND submissions
Demonstrated success in managing CROs and external consultants
Excellent communication and leadership skills with ability to influence cross-functional teams

Preferred

Experience with peptides or antibody-drug conjugates (ADCs)
Expertise in obesity or cardiovascular metabolism research
Prior authorship or significant contribution to IND submissions
Familiarity with all relevant bioanalytical platforms
Ability to operate effectively in a small, entrepreneurial biotech environment

Company

Third Rock Ventures

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Third Rock Ventures invests in transformational life science companies that show high growth potential.

H1B Sponsorship

Third Rock Ventures has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (2)

Funding

Current Stage
Growth Stage

Leadership Team

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Kevin Gillis
COO / Partner
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Cynthia Clayton
Head of Communications
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Company data provided by crunchbase