Serve as the PMx lead for project team and provide strategic and hands-on expertise in model-based approaches.
Lead model based dose selection for FIH study.
Lead model based dose selection and dose optimization during clinical development 
Conduct PopPK and ER analysis to support BLA submissions
Provide scientific trainings to non-ClinPharm colleagues in Elpiscience. 
 

Ph.D. in Pharmaceutical Science, Clinical Pharmacology or a related field in the biological sciences 
At least 3 to 5 years in combined industry, regulatory and postdoctoral experience in the field of Clinical Pharmacology and Pharmacometrics
Experience in the early and late-stage development of biologics is essential
Good hands-on skill in PK/PD modeling tools (E.g,NONMEM,Phoenix WinNonlin/NLME and R)
 

• Contributes to the planning, preparation, writing and review of periodic aggregate safety reports.
• Review standard design of tables, figures, and listings for safety data from clinical studies.
• Participate in development of safety-related data collection forms for clinical studies.
• Conduct signal detection, evaluation, and management .
• Perform data analysis to evaluate safety signals and write up analysis results in collaboration with the GSO.
• Prepare safety assessment reports and other safety documents and regulatory responses.
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.

• Expertise in oncology pharmacovigilance.
• Postgraduate qualification (Medical Degree, Pharm D or equivalent).  In addition, possess significant industry experience gained from the Pharmaceutical or Biotech industries (or related).
• Your background will be complemented with experience gained in working in cross-functional teams with successful product development and commercialization based on strong science, commercial insights, market research and competitive intelligence.
   

• Antibody developability assessment is mandatory, including antibody’s structural characterization, including intact mass, sequence confirmation, PTM and Glycan profiling, stability characterization, including: SDS-PAGE, SEC, HIC, CE-SDS and iCIEF.
• Recombinant protein purification on AKTA or other high-throughput antibody purification system is required occasionally.
• Keep laboratory records and present data to the project team.

• Ph.D. or M.Sc. in pharmaceutical analysis, protein chemistry, biology, biochemistry, structural biology or related fields.
• Protein QC experience including SEC/HIC/Glycan profiling/CE-SDS/iCIEF by using HPLC/UPLC/Maurice. Familiar with different chromatography methods to analyze protein is preferred.
• Experience in protein conformational and thermal stability analysis is a plus, Tm /Tagg/Tonset /KD detection.

This position will be responsible for crafting and implementing the strategic and operational aspects of clinical portfolio management.

• Management of strategic allocations and project management of the early clinical development project portfolio aligned with company strategy.
•  Management of strategic allocations of functional resources for Clinical teams.
•  Support for various project plans within a strategic framework aligned within the Clinical team.
• Work closely with all functional heads in R&D, from exploratory/target assessment phases to proof of concept in the clinical.
• As leadership team member and as such influence the general direction, goals, and strategies across the team.
•  Regular representation of science and portfolio internally and externally.

• At least Master’s degree in life science or related areas, or PhD, MD is preferred.
• Significant knowledge of and at least 12 years work experience in Pharmaceutical R&D, experience in Clinical function is preferred.
• Proven track record in a leadership role with multiple projects and programs.
• Attested ability to motivate and inspire a diverse group of senior leaders and cross functional colleagues at all levels to deliver extraordinary results.
• Strong communication, presentation and interpersonal skills, and the ability to form strong cohesive partnerships.
•  Excellent judgment and analytical skills with a demonstrated ability to diagnose issues, manage conflict, and provide alternative solutions.
• Solid understanding of finance and budgeting processes.
• Demonstrate Elpiscience values of ownership, courage and rigor.

• Design, plan and execute in vitro and ex vivo assays to provide translational data that bridges discovery thinking with clinical needs for our programs at various maturity states from target idea to screening and asset optimization prior to candidate selection.
• Identification of novel or most suitable biomarkers for patient selection or stratification as well as monitoring of pharmacodynamics in animal models and patients as needed for clinical studies.
• A team player mentality and interest in managing external CRO activities are required to connect with all internal partners and external collaborators to foster a productive culture and deliver results.

• Master or PhD degree in biochemistry, cell biology, pharmacology or clinical sciences; candidates with immunology and/or oncology background are strongly preferred.
• Significant hands-on experience in assay development or biomarker development, 3D cultures systems or exosome biology.
• Extraordinary flexibility and ability to think independently but work collaboratively within a big multidisciplinary matrix team of a fast-growing biotechnology organization.

• Provide technically expertise to design, develop and perform hits finding for drug discovery.
• Provide scientific input into experimental design and data interpretation. 
• Work in a close matrix team with other capabilities/disciplines to perform MoA studies. 

• Ph.D./Master’s degree in biochemistry, cell biology, pharmacology or other related field, immunology background preferred.
• Familiar with immunological assays such as M1/M2, T cell proliferation, ADCC, ADCP, and so on, is a plus.
• Ability to work independently as well as collaboratively within a multidisciplinary team.