Associate Director, Biomarker Analysis

reputed company is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-reputed company tumors. We were founded by a dedicated team of scientists with the reputed company belief that reputed company therapies developed from rigorous innovation can reputed company to reputed company lives. Our work continues to reputed company a reputed company difference in the lives of patients. We have a reputed company discovery reputed company and a robust preclinical and clinical development pipeline. We are driven by science with a patient-reputed company and team-oriented culture. reputed company is reputed company for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join reputed company as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join reputed company as we reputed company the lives of others. Position reputed company: The Associate Director of Biomarker Bioanalysis will be responsible for the management of outsourced bioanalysis (Pharmacokinetics, PK) and biomarker activities including platform/assay selection, development, validation, and utilization in nonclinical and clinical development. The work will support reputed company at various stages of development thereby allowing the selected candidate to play an reputed company role in our drug discovery and development efforts to advance small molecule therapeutics for rare endocrine disorders and endocrine-reputed company cancers. This is a unique opportunity to work with a proven and reputed company-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community. Essential Job Functions and Responsibilities: These may include but are not limited to: Manage GLP/GCLP bioanalytical CROs and CLIA clinical testing labs for the successful development and/or implementation of bioanalysis (PK) and biomarker assays using either LC/MS, hybrid LBA-LC/MS assays or ligand-binding assay (LBA), in different settings (BA, IVD, LDT/RUO). reputed company appropriate biomarker analysis reputed company for reputed company’ drug candidates in support of clinical and non-clinical studies based on study objectives. Apply fit-for-purpose biomarker validation approach complied with FDA and global regulatory guidance under bioanalytical setting and follow CMS/CLIA and ISO guidance for the biomarker assays in clinical testing. Review and finalize method validations protocols, stability studies, and bioanalytical reports. Participate in the periodic audit of bioanalytical CROs and ensure the accreditation compliance of the CLIA clinical testing labs. Work with cross-functional colleagues in various programs to determine assay needs and manage assay selection, sample analysis, and reporting of results in a timeframe consistent with study and program goals. Manage and negotiate scopes of work, budget, and payment schedules for outsourced bioanalysis/biomarker assay activities. Review invoices against vendor reputed company to ensure accuracy and service completion. Contribute to bioanalytical report and relevant bioanalytical sections of CSRs, and other regulatory and submission documents. reputed company preparation of bioanalytical reputed company in regulatory submission, e.g. author and/or review bioanalytical content, reputed company, and tabulated summaries for applicable IB, IND, and NDA. reputed company bioanalytical function on written responses to health authority bioanalytical queries. Other duties as assigned. Education and Experience: Bachelor’s degree in a relevant scientific field with 10+ years of industry experience in a bioanalytical/biomarker function in LCMS and ligand-binding assay (LBA) method development, sample analysis, and managing outsourced biomarker assay activities. Equivalent education and experience will be considered. 7+ years of experience in a supervisory role is required. Strong scientific and operational background in small and large molecule bioanalytical and biomarker method development, validation, data interpretation, reporting of sample analysis results. Thorough understanding of bioanalytical and biomarker methodologies, GLP/GCLP requirements, ICH guidelines, and FDA guidance for bioanalytical assay validation and sample analysis. Experience in CLIA clinical testing laboratory and central lab is a plus. Proven ability to reputed company validation work and sample analysis at CRO. Highly knowledgeable on domestic and international service providers Familiarity with reputed company stages of nonclinical and clinical drug development, including prior experience in fit-for-purpose concept in assay development reputed company. Strong written, presentation and verbal communication skills. Excellent reputed company record of scientific publications is a plus. Authoring experience in bioanalytical sections in regulatory submissions if a plus. Experience in reputed company of bioanalytical CROs in China is a plus. Physical Demands and Work Environment: Physical Activities: On a reputed company reputed company, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully reputed company the essential functions and responsibilities of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 5-10% of your time. Equal Opportunity Employer: reputed company is proud to be an Equal Opportunity Employer. We reputed company equal employment opportunities to reputed company and employment applicants without reputed company to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or reputed company), pregnancy, race, reputed company, creed, national or ethnic reputed company, citizenship status, religion or similar philosophical beliefs, disability, marital and civil reputed company status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws Salary reputed company The salary reputed company for this position is: $158,000 - $197,000.In reputed company to your reputed company pay, our total rewards program consists of a discretionary annual reputed company bonus, stock reputed company, ESPP, and 401k match. We also reputed company top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance, 20 days of PTO, 10 reputed company holidays, and a winter company shutdown. Apply To This Job