Associate Director, Toxicology
Cytokinetics- (None specified in the provided text)
Salary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Develops drugs for muscle function disorders
South San Francisco, California, United States
- (None specified in the provided text)
- JD degree - Admitted to at least one state bar (admitted to California bar or as Registered In-House Counsel in California is a plus) - Minimum of 10 years of experience as in-house counsel in a biotechnology, pharma or healthcare company or a combination of in-house at large public company and/or nationally recognized law firm specializing in the area of interest - Strong working knowledge of U.S. securities laws and NASDAQ requirements - Experience with securities filings of public companies…
- B.S degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred - Current and strong working knowledge, interpretation/implementation of United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations …
- PhD in Pharmacology, Pharmaceutical Sciences, Chemistry, or related field - 8+ years of relevant experience in bioanalytical sciences and pharmacokinetics within the pharmaceutical/biotech industry - Deep expertise in LC-MS/MS, Orbitrap, Q-TOF and HPLC methods - Strong background in PK modeling (WinNonlin, Phoenix, NONMEM, R, etc.) and interpretation of PK/PD data - Experience with regulatory submissions (FDA/EMA/ICH guidelines) and working in a GLP/GCP environment - Proven leadership skills w…
The Associate Director of Quality Assurance must have experience in pharmaceutical manufacturing, with a primary focus on overseeing Quality Control (QC) data for stability studies and lot release. This role requires a strong understanding of cGMP, FDA, EMA, and other relevant regulations, as well as experience with data review and approval processes for various product stages. Experience with CMO oversight and knowledge of CMC regulatory submissions are also important qualifications.
- BA or BS in a life sciences-related discipline with a minimum of 9 years of combined experience relevant to CTT - Ability to work both independently and in cross-functional team environments with minimal supervision - Strong written and verbal communication skills, with ability to engage and disseminate information among appropriate stakeholders for effective development of CTT-related materials - Demonstrated ability to lead development of CTT-related deliverables, including excellent project…
- Ph.D. in Statistical Genetics, Genetic Epidemiology, Bioinformatics, or a related field or equivalent - 8+ years of postdoctoral or industry experience in statistical genetics or genetic epidemiology - Strong expertise in analyzing large-scale genomic datasets, including GWAS and sequencing data - Proficiency in statistical programming languages (R, Python) and bioinformatics tools - Experience with Mendelian randomization and multi-omics data integration (highly desirable) - Familiarity with …
- PhD in computational biology, computer science, bioinformatics, human genetics, or related field - Demonstrated expertise in multidimensional data analysis - Previous experience analyzing multimodal data from population biobanks such as UK Biobank, All of Us, FinnGen or Genomics England is highly desired - Proven experience applying AI/ML techniques to biological problems (whether through academic research or personal side projects) is highly valued - Well-articulated career goals in research …
- 10 - 12+ years of related work experience (Director candidates will typically bring 12+ years; Associate level candidates may be considered with 10+ years and strong potential), including 8+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry - Experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus - Proven experience serving as a primary RA-CMC contact to Health Authorities, with full strategic responsibility - Ba…
- Bachelor's Degree - 5+ years of experience in biotech/pharma sales - Expertise in evaluation of territory market trends and strategic planning that drives results and exceeds sales objectives - Experience selling to complex accounts, identifying influential stakeholders, and meeting patient needs - Clinical acumen with a passion for understanding and championing the needs of customers and their patients - Agree to credentialing requirements for access to academic institutions, medical faciliti…
- Strong stakeholder engagement skills - Deep understanding of regional healthcare dynamics in DACH (Germany, Austria, Switzerland) - Ability to operate independently while collaborating proactively across functions - Knowledge of regional and local reimbursement regulations, pricing, and health policy in cardiology
- Bachelor's Degree - 5+ years of experience in biotech/pharma sales - Expertise in evaluation of territory market trends and strategic planning that drives results and exceeds sales objectives - Experience selling to complex accounts, identifying influential stakeholders, and meeting patient needs - Clinical acumen with a passion for understanding and championing the needs of customers and their patients - Agree to credentialing requirements for access to academic institutions, medical faciliti…
- Bachelor’s Degree preferred - 5+ years’ experience managing or supporting TMF activities
- Bachelor’s degree required; advanced degree in Life Sciences or an MBA is preferred - Minimum of 10 years of experience in the pharmaceutical or biotechnology industry in field-based sales roles - At least 2 years of proven success in sales leadership, ideally in relevant areas
- Expertise in French pharmaceutical regulations, particularly with ANSM for establishment status and operator applications - Ability to define, structure, and deploy a local Quality Management System (QMS/PQS) - Proficiency in drafting, validating, deploying, and updating local SOPs across key areas (pharmacovigilance, product complaints, recalls, GDP, etc.) - Experience in managing local regulatory activities (AMM/variations, French labelling/notices, regulatory follow-up) - Knowledge of pharm…