The Director, Clinical Pharmacology & Pharmacometrics,you will be responsible for the clinical pharmacology and pharmacometric deliverables for clinical development assets from phase I III and developing a clinical pharmacology plan and dose selection and prediction using mathematical and statistical models to study complex interactions between drug and patients, between

CHO mammalian cell cultures in shaker flasks, WAVE bioreactors, and benchtop bioreactors. Media and feed formulation as needed for experiments. Data management and analysis including metabolite, gas, cell count, and titer data. Media and feed studies to support process development on early phase programs. Scale down modeling and range finding to support development and pr

Scale down and range finding study execution. Purification by FPLC of Pilot scale batches. Implementation of multiple liquid chromatography types (i.e Affinity, Ion Exchange, HIC) Buffer formulation, resin selection and capacity study execution. Filter loading and fouling study execution. Intermediate stability analysis. Formulation and stability study support. Protein ch

Accepts designated, research focused projects while proposing ideas and solutions to challenges Perform in vitro and ex vivo research bench work Open to learning rodent handling and dosing techniques Ability to work closely with a small team as well as independently with supervision Strong organizational and record keeping skills, written and verbal communication skills,

Willingness to work with rodents. This includes animal handling, dosing (IP/IV/SC/PO), bleeding, necropsy, tissue collection and wet lab sample processing. Some basic molecular biology techniques RNA isolation, qPCR, Western Blot, ELISA Maintain clear, accurate records of experimental details and summarize data as needed in study reports. Pay attention to details and prov

Perform in vitro and ex vivo research bench work RNA isolation and expression analysis by qRT PCR Perform in vitro assays to confirm the expression and activity of candidate therapeutic proteins (Western Blot, ELISA) Perform antibody staining and flow cytometic analysis of hematopoietic cells Maintain clear, accurate records of lab work and summarize results as needed in

Maintain and culture multiple cell lines Participate in protocol development and optimization of cellular assays Conduct reporter assays to assess cellular signaling events Regularly perform gene expression, protein detection analysis Maintain accurate and detailed laboratory records Collaborate with team members on research projects Qualifications Currently enrolled as a

Implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in house analyses as well as out sourced programming deliverables Build SAS datasets from clinical databases, external data sources, and other data sources, utilizing SDTM and ADaM guidelines. Produce and/or validate tables, listings, figures, and analysis datase

Technical Support and Troubleshooting Provide the highest level of technical support and guidance to research teams, addressing both hardware and software issues. Work closely with researchers to integrate new technology and tools that enhance research capabilities. Train staff on new IT systems and best practices. System Administration & Integration Install, configure, a

Independently author, review, and manage clinical documents as the lead medical writer. Lead strategy discussions for document development and contribute to medical writing process development. Manage contract medical writers. Primary Responsibilities Independently authors high quality, scientifically accurate, complex clinical documents, ensuring consistency between rela

Lead the biostatistics team, including recruiting, developing, and retaining top talent Lead the development and delivery of statistical methodology, biostatistical subject matter expertise, statistical tools/applications development to support the development and marketing of new medicines Partner with key stakeholders/functions to ensure the timely delivery of high qual

TheCTA is responsible forsupporting the Clinical program teams and may assist the teams across multipleclinical studies. The CTA would also participate in broader clinical operationsactivitiesand initiatives such as the development and refinement of new processes. Responsibilities Clinical Study and Program Support ~70% Support clinical study teams in the delivery of key

Signal detection, evaluation, and management from clinical trials Perform data analysis to evaluate safety signals and write up/ present analysis and results Collaborate with other applicable functional areas, including but not limited to Biostatistics, Clinical, Quality, Regulatory Affairs to identify, evaluate and manage safety signals Assure oversight for the review of

Ensures high quality and on time submissions, including for INDs, IMPDs, CTAs and BLAs, that align with company strategies and Health Authority requirements. This includes planning, coordination and tracking the CMC dossier towards submission milestones. Interact with cross functional departments to ensure deliverables are met according to the corporate goals. Coordinate

The Senior Director, Scientific Communications is a seasoned Medical Affairs professional with an established track record of creating, leading, and delivering high impact scientific publication and communication program(s). S/he will oversee publication planning and execution along with being an integral part of Program Team(s) across the Keros portfolio. Areas of focus