Sr. Director, Bioanalytical and Biomarker Development
Sr. Director, Bioanalytical and Biomarker Development
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Job Description
Position Summary:
The Bioanalytical Development & Biomarker Strategy subject matter expert plays a critical individual contributor role in shaping and executing bioanalytical and biomarker strategies across therapeutic programs. This role combines deep scientific expertise strategic insight and cross-functional leadership to ensure high-quality data generation and regulatory compliance in support of drug development.
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Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Specialized Scientific Expertise: Apply deep understanding of disease biology and therapeutic mechanisms of action to guide bioanalytical strategy. Lead assay development qualification validation and execution for measuring drugs (across modalities) metabolites biomarkers and other analytes in biological matrices
- Strategic input Into Analytical Methods:Select appropriate bioanalytical approaches tailored to therapeutic modalities (e.g. small molecules biologics gene therapies). Collaborate with laboratory teams to develop and validate PK PD immunogenicity and biomarker assays. Ensure analytical methods meet regulatory standards and are fit-for-purpose and validation-ready. Serve as a subject matter expert in resolving complex analytical challenges and integrating cutting-edge technologies
- Significant knowledge on the Regulatory processes: Ensure bioanalytical studies comply with GLP/GCP/GMP and other relevant regulatory standards. Review non-clinical and clinical protocols for sample strategy and biological relevance. Author and review bioanalytical reports protocols and regulatory submission content. Partner with compliance teams to identify and qualify CROs for regulated studies
- Cross-functional Collaboration: Work closely with translational science clinical development data management biostatistics clinical operations and regulatory affairs to integrate bioanalytical strategies into program plans. Facilitate method development and transfer to internal or external labs for regulatory support. Communicate complex scientific concepts effectively to non-expert stakeholders
- Data management and Interpretation: Deliver high-quality bioanalytical data within tight timelines while maintaining scientific integrity. Oversee integration of complex datasets from diverse analytical platforms. Translate bioanalytical and biomarker data into actionable insights for drug development. Build strong partnerships with pharmacokineticists pharmacometricians and clinical pharmacology scientists
- External Landscape: Monitor industry trends emerging technologies and evolving regulatory guidance in bioanalysis and biomarkers. Engage with external consortia working groups and regulatory bodies to influence industry standards and best practices
Requirements:
- PhD or equivalent advanced degree in biochemistry biology molecular biology analytical chemistry or related field
- Prefer at least 15 years of relevant industry experience in translational science and drug development
- Strong knowledge and experience with supporting regulated studies
Skills and Expertise:
- Extensive experience in bioanalytical sciences within a regulated drug development environment. Strong knowledge of regulatory requirements and strategic application of bioanalytical methods
- Design and implement biomarker strategies across discovery translational and clinical stages. Align biomarker plans with program objectives regulatory expectations and intended use. Define context-of-use for biomarkers (diagnostic prognostic predictive pharmacodynamic) at the different stages of drug development
- Excellent verbal and written communication skills across all levels both within an organization and with external collaborators/companies with the ability to recognize articulate and accept calculated risks to make informed decisions
- Experience with multi-modality (biologics small molecules and oligonucleotides) therapeutics desired. Working knowledge of all functional areas of drug development including biology toxicology clinical development and diagnostic development. Proven leadership in cross-functional teams and external collaborations
- Demonstrated experience in the appropriate application of various scientific technologies into translational research strategies and working knowledge of all functional areas of drug development including biology toxicology clinical development diagnostic development etc.
- Demonstrated ability of working effectively to influence stakeholders in a highly dynamic matrix organization and the ability to grow new leaders and delegate key projects appropriately
Lab:
- Work in a lab environment requiring special protective clothing over the head face hands feet and body. This role requires the ability to wear personal protective equipment
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The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$258300 - $319100 USD
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Required Experience:
Exec
Employment Type
Full Time
