Current openings at Kardigan

Position Title: Director, Biostatistics  Department: Development- Data Science  Reports To: Sr Director, Biostatistics     Job Overview  We are seeking a highly skilled and motivated Biostatistician to lead our biometrics function in one of the late-phase programs for cardiovascular drug development.  As the Biostatistician, you will be the compound lead, representing biometrics at the project team level.  You will be responsible for discussing and shaping the clinical development plan, study design, endpoint selection, statistical analysis plan, and regulatory submission and publication strategy to support pursuant of precision medicine. This role involves overseeing CROs and collaborating with cross-functional teams to deliver high-quality analysis outputs and interpret results. Initially, this position is an individual contributor role with the potential to expand to include direct reports as the team grows.   Essential Duties and Responsibilities  Serve as the compound lead, representing the biometrics function (biostat, programming and CDM) in global project teams and contribute to the clinical development plans, study designs, endpoint selections, statistical analysis plans, regulatory submissions, and publication strategies.    Collaborate with clinical, regulatory, medical affairs, and other teams to ensure cohesive and integrated project strategies.  Contribute to clinical protocol development and study reports, including authoring of the Statistics section and reviewing of other sections by applying statistical principles.  Perform exploratory analysis to deepen understanding of the disease biology and MOA of the molecule.  Author or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listings.  Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.  Design and specify randomization schedules; review and approve test randomization lists.  Provide statistical input to data monitoring committee (DMC) charters.  Oversee the CROs or internal teams to deliver high-quality and timely analysis outputs and interpret the results.  Review analysis dataset specifications and perform QC/QA of statistical deliverables, including validation of key analysis results.    Manage statistical activities in support of NDA/MAA or other regulatory submissions.  Address statistical questions/comments from FDA and other regulatory agencies.  Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.  Contribute or lead standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts.  Provide guidance and oversight to ensure compliance with regulatory standards and best practices.  Qualifications and Preferred Skills  PhD in Statistics, Biostatistics, or a related scientific field with 8+ years of experience, or MS with 10+ years of experience in clinical trials, drug development, the pharmaceutical industry, or healthcare  Expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.   Knowledgeable of machine learning approaches for classification and predictive modeling.  Excellent communication and presentation skills, with the ability to convey complex statistical concepts to non-statisticians.  Strong knowledge of statistical software (SAS, R or Python) and proficiency in implementation of advanced analytical methods especially for data visualization.  Experience in managing CROs and collaborating with cross-functional teams.  Experience with NDAs, and MAA’s is highly desired.  Experience with cardiovascular drug development and biomarker research is preferred.  Demonstrated ability to work independently and as part of a team in a fast-paced, dynamic environment. 

Position Title: Scientist, DMPK (Drug Metabolism & Pharmacokinetics) Department: Discovery Research  Reports To: Director, DMPK    Job Overview  Kardigan is looking for a highly motivated and detail-oriented DMPK Scientist to join our dynamic research team. This role offers a unique opportunity to contribute to both early-stage discovery and later-stage development by generating high-quality ADME/PK data to support our small molecule drug pipeline. The ideal candidate will bring hands-on expertise in bioanalysis, in vitro assay development, and mass spectrometry, along with a collaborative spirit and a passion for scientific excellence.    Essential Duties and Responsibilities  Key Responsibilities will include lab-based duties, but are not limited to the following:  Develop in vitro assays and independently generate high quality data to support drug discovery and development  Perform bioanalysis of structurally diversified small molecules for in vitro assays and develop fit-for-purpose sample preparation protocols and analytical methods by liquid chromatography and mass spectrometry  Execute, analyze, and interpret in vitro drug metabolism assays to understand the ADME properties of small molecules in supporting discovery and development programs  Culturing, testing, and validating cell or assay systems and ensuring cleanliness of labs  Bioanalysis of pharmacokinetic samples and determination of pharmacokinetic parameters  Maintain good documentation practices including laboratory notebooks, protocols, and reports writing; present data in team/project meetings as necessary    Qualifications and Preferred Skills  Highly motivated individual has a Ph.D in pharmaceutical sciences, chemistry, bioanalysis, or biomedical science related fields or with at least 5 years (M.S. degree) or 8 years (B.S. degree) industrial/ academia experience.  Demonstrate excellent verbal and technical communication, independent thinking, with the ability to interpret results, determine next steps and present data.  Ability to work in a team oriented, innovative and fast-paced environment focusing on discovery and development of new drugs for treatment of cardiac diseases.  Experience as a project representative is a plus.  Expertise and experience in one or more of the following areas are required:  Experienced in development of LC-MS-based analytical methods and sample preparation for small molecule analysis. Proficient in operation, maintenance and troubleshooting for high end scientific instrumentation, including general liquid handling equipment, Thermo Orbitrap Q-Exactive, Exploris 240 HRAMS, Sciex or Thermo triple-quad mass specs is highly desired. Hands-on experience in culturing primary and recombinant cell lines, developing cell-based and in vitro drug metabolism assays. Prior experience and knowledge in drug metabolism assays (i.e. metabolic stability assays in liver microsomes and hepatocytes, protein binding, cytochrome P450 inhibition assays and bioanalysis of PK samples), PK modeling programs such Phoenix Winnonlin, SimCyp and DMPK concepts to support ADME studies are a plus.