Director, Clinical Bioanalysis
Job Posting for Director, Clinical Bioanalysis at Longboard Pharmaceuticals, Inc.
Job Title: Director, Clinical Bioanalysis
Reporting To: Vice President, Head of Clinical Pharmacology & Pharmacometrics
Department: R&D: Clinical
FLSA Status: Exempt
Location: Remote or Hybrid in San Diego, office (2-3 days a week)
Position Summary
The Director, Clinical Bioanalysis will be a key member of the Clinical Pharmacology group and will report directly to the VP of Clinical Pharmacology & Pharmacometrics. This individual will apply clinical bioanalysis knowledge, skills, and expertise for independently planning and supporting the clinical bioanalysis needs for various assets at different stages of clinical development. Also, the individual will be an expert in authoring and reviewing bioanalytical sections of eCTD modules and address any IR related to bioanalytical data.
Responsibilities include but may not be limited to:
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $220-240k. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
#LI-Hybrid
Reporting To: Vice President, Head of Clinical Pharmacology & Pharmacometrics
Department: R&D: Clinical
FLSA Status: Exempt
Location: Remote or Hybrid in San Diego, office (2-3 days a week)
Position Summary
The Director, Clinical Bioanalysis will be a key member of the Clinical Pharmacology group and will report directly to the VP of Clinical Pharmacology & Pharmacometrics. This individual will apply clinical bioanalysis knowledge, skills, and expertise for independently planning and supporting the clinical bioanalysis needs for various assets at different stages of clinical development. Also, the individual will be an expert in authoring and reviewing bioanalytical sections of eCTD modules and address any IR related to bioanalytical data.
Responsibilities include but may not be limited to:
- Serve as a core member of cross-functional drug development teams.
- Develop and implement a comprehensive clinical bioanalytical strategy for assets from initial first-in-human to later clinical development phases leading to NDA and global submissions with emphasis on high quality, and compliant delivery of bioanalytical data.
- Identification, assessment, and selection of appropriate vendor(s ) to develop/validate assays and perform quantitative bioanalysis of clinical study samples and work with internal departments (i.e., QA) to complete vendor onboarding process.
- In depth and thorough scientific and technical oversight on method development/ validation/ transfer, and sample analysis and ensure regulatory compliance with the chosen clinical bioanalysis vendors with a special emphasis to manage and resolve issues relevant to bioanalysis on an ongoing basis.
- As a member of CPP group, effectively collaborate with internal stake holders (i.e., clinical /nonclinical development, clinical operations, QA, regulatory, legal, finance etc.).
- Prepare high quality bioanalytical authoring sections (i.e., 2.7.1 eCTD) and review of appropriate sections of clinical and regulatory documents and response to queries from regulatory agency on bioanalysis.
- Prepare meta-analyses reviews of clinical bioanalysis work on an ongoing basis (i.e, semiannually or other frequency as applicable) to ensure adequate performance of the assays(s) and advanced preparedness for any regulatory scrutiny.
- Foster positive relationships with external vendors.
- Advanced planning and strategy development for bioanalytical outsourcing needs with executable plans to ensure pipeline support.
- An advanced degree (PhD) in organic/analytical chemistry, or a closely related scientific discipline with emphasis on small molecule assay development
- A minimum of 10 years of relevant experience in regulated clinical bioanalysis (at least 5 years of relevant experience in pharmaceutical industry and/or CRO is required)
- A strong scientific and technical skills (LC/MS or LC-MS/MS assays; LLE, SPE, Chiral platform, DBS, etc) is required. Prior GxP experience is highly preferred.
- Successful track record of supporting clinical Bioanalysis for assets from IND to clinical development/NDA
- Prior people management experience in a pharmaceutical/CRO bioanalytical group is a plus.
- Previous direct hands-on experience at the bench-level for developing, problem solving and/or implementing bioanalytical assays in small molecule drug development is require
- Well versed with the current applicable (i.e., global) bioanalytical regulatory guidelines including FDA/EMA and ICH-M10 guidelines
- Experience in managing external vendors is required.
- Excellent oral and written communication skills and strong negotiation skills.
- Demonstrated ability to work effectively and collaboratively on cross-functional teams.
- Strong organizational and process management skills and proactively think and prioritize/ manage multiple projects is required.
- Record of publications, presentations, and volunteering for professional organizations
At Longboard Pharmaceuticals, our mission is to enhance the lives of individuals battling profound neurological conditions. Collaboratively, we foster an inclusive company culture and an inviting environment that we take immense pride in. We actively seek dynamic, talented, and dedicated individuals to join our team.
Pay Transparency
The expected salary for candidates who work in La, Jolla, CA is $220-240k. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Longboard Pharmaceuticals, Inc is a multi-state employer and will consider candidates based in remote work locations.
Benefits
At Longboard, we prioritize the well-being and satisfaction of our employees, understanding that benefits play a crucial role in their overall compensation and life quality. We take pride in providing a robust suite of benefits designed to safeguard the health and happiness of our team members, their families, and their lifestyles.
Our benefits currently include:
- Hybrid work schedule out of our La Jolla office, 2-3 days a week
- Competitive compensation package including bonus opportunities and stock options
- Medical, Dental & Vision Plans
- 401(k) Plan, including company match with immediate vesting
- Flexible Time Off, including one week off in the summer and one week off around December holidays
- 11 paid company holidays per year
- An opportunity to do truly meaningful work to make a lasting impact
- Longboard Perks (on-site gym, garage parking, company-sponsored events, etc.)
- Flexible spending account for medical care
- Life insurance, short and long term disability plans
#LI-Hybrid
Salary.com Estimation for Director, Clinical Bioanalysis in La Jolla, CA
$217,558 to $295,496
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