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Talent recruiting for our business collaborator, iVIEW Therapeutics Inc.
iVIEW Therapeutics (iVIEW) is a clinical stage specialty pharmaceutical company focused on the research and development of innovative ophthalmic therapeutics. Out of the many assets in its current pipeline, the lead compound iVIEW-1201 for the treatment of viral conjunctivitis has entered global phase II clinical trials in early 2019. iVIEW is located to Princeton, New Jersey, where the laboratory and office spaces totaled up to approximately 11,045 square feet. The company will offer a competitive salary, comprehensive benefits package, and employee stock options accordingly.
Key Responsibilities:
1. The candidate must be very familiar with the latest trend in the global pharmaceutical industry, especially the field of ophthalmology. He/She will create the business development strategies for the global market
2. Lead licensing (in-licensing and out-licensing) functions upon conducting strategic financial analysis. Establish new product combinations
3. Identify opportunities for further growth, analyze acquisition targets (lead the due diligence process), and negotiate new deals with pharmaceutical and biotech companies at home and abroad
4. Expand new and maintain a long-term strategic alliance with top pharmaceutical companies, universities, research institutes, contract research organizations (CROs), and contract manufacturing organizations (CMOs)
5. Monitor market development and major competitors’ activities from the perspectives of new technology, market, product registration, and pricing
Job Requirements:
1. Education background: A Master’s or Ph.D. degree in Biology, Chemistry, Pharmaceutical Sciences, or related field. An M.D. degree is also welcomed
2. 5+ years of professional experience, including deal in-licensing, structured transaction, project value analysis, mergers and acquisitions, fundraising, investment in the pharmaceutical industry, and familiarity with policies and regulations for new drug applications
3. Have a rich and diverse network in the pharmaceutical industry
4. Rich negotiation experience, strong analysis ability, and business acumen
5. Strong communication skills in English. Able to lead conversations in business meetings
Key Responsibilities:
1. Design and implement formulation screening programs, determine formulation development conditions, and conduct research on pre-formulation stability and physicochemical properties based on literature search and new product features
2. Participate in the pharmaceutical preparation/ formulation development, optimization, and production of the current programs
3. Develop drug registration applications and related materials
4. Report work progress to supervisor regularly
5. Communicate and coordinate with members within the team and from other departments
6. Support other activities in a timely manner as assigned by the management
Job Requirements:
1. A Master’s or above degree in Pharmaceutical Sciences or related field
2. Work independently to conduct formulation screening. Previous experience in pharmaceutical formulation screening and process R&D preferred
3. Enjoy pharmaceutical preparation/formulation research and development and have a long-term career plan in this area
4. English proficiency above Level 6. Must be proficient with MS Office software
5. Excellent ability to execute new projects, learn new things quickly, and function well in a team
6. Must have a firm understanding of regulatory requirements to ensure all new project promotion, development, and troubleshooting strategies conform to relevant regulatory standards
Key Responsibilities:
1. Perform product analysis, method development and validation (by HPLC, LC-MS, GC, GC-MS). Develop quality standards and performance measurements. Carry out product sampling and testing for quality control
2. Assist in the analysis of new drugs and formation development
3. Responsible for literature search and scientific information retrieval
4. Develop and review Standard Operating Procedures (SOPs) for R&D and quality assurance
5. Support other activities as assigned by the management
Job Requirements:
1. A Master’s or above degree in pharmaceutical analysis, analytical chemistry, pharmacology, or related field
2. Strong ability in reading and analyzing English research articles. Familiar with official standards for medicines, eg., CP, USP, EP. Ability to search, analyze, and organize NMPA and FDA documents
3. Experience in qualitative research of regular medical injections. Candidates with experience in qualitative research of difficult medical injections will be considered first
4. Meticulous work attitude with a strong sense of responsibility. Can take matters of confidentiality seriously. Mentally strong to withstand stressful situations. Able to thrive in a team-driven work environment. Creative and highly self-motivated to actively learn new things
5. Familiar with laboratory analytical instruments, e.g., HPLC, GC, DSC, IC, microscope, etc., and be able to troubleshoot and fix common problems
Key Responsibilities:
1. Responsible for pharmacology and toxicology studies and evaluate the drugability of the company’s innovative drugs. Participate in new project establishment and evaluation
2. Develop data analysis plans for preclinical toxicology and pharmacology. Plan and design experiments for in vitro, in vivo DMPK/PD, and toxicology studies on drug candidates. Conduct risk assessment and financial budgeting
3. Track, review, and summarize worldwide academic research articles based on the internal R&D and project needs. Provide professional support in evaluating drug efficacy, pharmacokinetics, and safety assessment
4. Test and evaluate physicochemical properties, crystal structure, and quality of new compounds. Provide guidance on the test and evaluation procedures
5. Support other activities as assigned by the management
Job Requirements:
1. A Master’s or Ph.D. degree in Immunology, Biology, Pharmaceutical Sciences, or related field
2. 10+ years of experience in the biomedical industry
3. Familiar with NMPA and FDA drug review guidelines, as well as laws and regulations on drug management. Ability in reading English scientific literature. Familiar with literature search and remain up-to-date with the latest development in the pharmaceutical industry
4. Strong background in pharmacology and immunology. Rich research experience in pharmacodynamics, pharmacokinetics, and safety evaluation
5. Excellent skills in project management, communication cross functional groups, coordination, leadership, and innovative problem-solving
6. Candidates with experience successfully registering investigational new drugs will be considered first
Key Responsibilities:
1. Manage CMC regulatory strategies for drug compounds currently under R&D: oversee project development process, technology transfer, and production of registration batches/ clinical batches/ process validation batches. Provide guidance for the company’s Formulation Department
2. Develop and review IND/NDA related documents according to CMC development guidelines of major markets
3. Organize and coordinate resources needed to achieve project development goals. Responsible for project progress, quality, costs, and risks
4. Lead the team to formulate project CMC development strategy, development plan, and budget planning. Manage issues that would occur during project implementation (technology, suppliers, resources, etc.) with relevant parties. Identify solutions and ensure continued implementation and effectiveness of the combination of science and development goals
5. Organize project CMC meetings regularly. Track project progress and action items. Identify and resolve potential problems during project development. Lead the team members to troubleshoot and propose reasonable solutions. Ensure smooth execution of every project and submit project progress reports on a regular basis
6. Support other activities as assigned by the management
Job Requirements:
1. A Master’s or Ph.D. degree in pharmaceutical sciences or related field
2. 10+ years of experience in the biomedical industry
3. Experience managing new drug R&D and production processes. 2+ years of experience managing new drug R&D programs. Understand the upstream, downstream, formulation/ preparation, and analysis methods of drug development
4. Familiarity with biopharmaceutical regulations and guidelines of NMPA and regulatory authorities abroad (FDA, EMA, etc.)
5. Strong English written and verbal communication skills. Comfortable using English in the workplace
6. Excellent organization, coordination, communication, logical reasoning, problem-solving skills. Great sense of teamwork and responsibility
Key Responsibilities:
1. Provide scientific and clinical expertise with leadership over all aspects of research and development. Guide and complete new drug R&D project. Establish program plans and strategies. Effectively assign appropriate roles in the team. Supervise the implementation of the team’s plans
2. Responsible for the preclinical development, submission, and approval of new drug IND applications
3. Responsible for R&D Department’s budgeting, program planning, and plan implementation for new drug development programs
Job Requirements:
1. A Ph.D. degree in Chemistry, Biology, Pharmacology, Toxicology, or related field
2. 15+ years of experience in drug discovery and preclinical development
3. Rich experience in leading the new drug R&D team, advancing new program into clinical stages, and receiving approvals
4. Strong ability in problem analysis and solving, communication, leadership, and management. Excellent professionalism and ability to function well in a team setting
5. Rich experience with IND and NDA
6. Strong management skills in project management and when interfacing with CRO
Key Responsibilities:
1. Prepare the Quality Module of the CTD for overseas product registration following drug regulatory guidelines of the specific country. Contents include but not limited to the product-related production process, analysis methods, Site Master Files, and other relevant documentation
2. Communicate and resolve product-related issues with manufacturers, overseas drug registration and listing partners, and regulatory authorities during the drug registration process. Advance registration and project process promptly. Ensure the approval of product registration in designated countries
3. Assist in the transfer of production processes and analysis methods involved in internationally registered programs
4. Prepare relevant technical documents and coordinate internal resources to ensure successful overseas drug GMP and QC regulatory audits
Job Requirements:
1. A Master’s or above degree in biomedical sciences or related field. Candidate with foreign- educated returnee background preferred
2. Familiar with laws and regulations of the pharmaceutical field. Able to summarize, interpret, and analyze relevant regulatory information
3. Have experience in drafting and composing complicated technical documents and normative documents. Know the relevant regulations of international registration and CTD documentation
Key Responsibilities:
1. Collect technical data and documents and compile new drug product submission materials according to the company’s requirements on to be submitted products
2. Prepare, submit, and supervise product registration documents. Interface with drug testing centers and evaluation centers for registered programs
3. Assist in updating product labels and information sheets to comply with NMPA’s relevant regulations
4. Assist in the coordination and communication of local pricing standards
5. Assist in collecting, organizing, and archiving the relevant information of competitors
6. Implement relevant policies within the company
Job Requirements:
1. A Master’s or above degree in biomedical sciences or related field
2. Familiar with Provisions of Drug Registration and relevant regulations. Familiar with medical device registration regulations and related government administration workflow
3. Capable of project management, organizing, planning, and solving problems effectively
4. Strong communication and coordination skills
Key Responsibilities:
1. Responsible for product evaluation and analysis. Assist in product research plans and new project establishment
2. Assist in drafting clinical research protocols. Develop research preliminary report
3. Write and edit clinical trial protocols and clinical trial results report following the guidelines and requirements (including NMPA requirements) of regulatory medical writing
4. Responsible for SAE evaluation and technical support of clinical programs
5. Responsible for quality check of clinical programs to ensure that all procedures performed during clinical trials strictly adhere to the procedures described in the approved clinical study protocol
6. Responsible for program training of CRA and QA
Job Requirements:
1. A BS or above degree in Clinical Medicine, Pharmacology, or related field
2. Excellent English written and verbal communication skills. Able to work collaboratively with collaborators from different countries
3. Familiar with national drug registration regulations and policies such as GCP. Familiar with the clinical trial general process
4. Have a positive work attitude, attention to detail, dependable, and able to withstand work- related stress
Key Responsibilities:
1. Responsible for planning, execution, and coordination of clinical programs. Lead the team to interface with CROs
2. Prioritize the implementation, supervision, and decision-making for clinical strategies and plans
3. Manage project progress, quality, and financial budget during clinical development. Provide prompt input and supervision to resolve major problems in the process of project advancement
4. Communicate and coordinate with project collaborators, clinical development experts, CROs, personnel from government regulatory affairs. Redirect clinical strategies and plans accordingly to ensure successful completion of clinical development and project meet the relevant registration requirements
5. Lead the team to organize, review, and submit clinical trial data. Prepare applications for clinical study registration
6. Assist BD team in the planning of pipeline expansion and product commercialization
Job Requirements:
1. A Master’s or above degree in Biomedical Science, Biology, or related field (An M.D. degree is also welcomed.)
2. 5+ years of experience in small molecule drug R&D and team management/ leadership roles. Candidate with experience submitting innovative drug Investigational New Drug (IND) applications to NMPA and FDA and interfacing with FDA preferred
3. Excellent English written and verbal communication skills. Able to independently search and review relevant scientific literature and compose diverse categories of reports
4. Familiar with the overall preclinical drug R&D process. Familiar with relevant drugs’ preclinical development and latest development status