About ACM Biolabs

ACM Biolabs Pte Ltd., an innovative biotechnology company situated on NTU campus, Singapore with a subsidiary (ACM Biosciences AG) in Basel, Switzerland. We are focused on developing our pioneering proprietary amphiphilic block-co-polymer based delivery platform (ATPTM) technology to advance multiple modalities that can be specifically delivered to the right tissues and right cell types.

ACM Biolabs Pte LTD is developing next generation medicines (e.g., immune modulators, vaccines -prophylactic and therapeutic). Our lead asset, ACM-001, uses polymersomes to deliver SARS-CoV-2 beta variant antigen and is being tested both intranasally and intramuscularly in humans in Phase 1 studies. ACM Biolabs using ATPTM platform technology is advancing medicines with its partners and building internal development pipeline.

Responsibilities

• Synthesis and characterisation of amphiphilic block co-polymers and or functional lipids.
• Establish protocols for scalable methods for synthesis of polymers and or lipids. 
• Work closely with a multidisciplinary team comprising of chemists, formulations scientists, Analytical chemists, biochemists & immunologists within the Company and with partners.
• Keep accurate record of experiments and results as required by pharma standards.

Professional Experience / Qualifications

• The candidate should ideally possess the following skills and experience:
• PhD in the field of Organic Chemistry/Polymer chemistry
• Knowledge in organic/polymer synthesis skills, ability to work with strong initiatives
• Familiar with synthesis and purification of compounds and/or polymers
• Familiar with characterisation techniques of polymers and lipids (e.g., GPC, NMR, LC-MS)
• Knowledge with self-assembling of amphiphilic polymers would be an advantage
• Candidates have good written/oral communication skills and track record of scientific publications.
• Fresh graduate is welcome to apply

Working place: Singapore

Responsibilities

1. Support new R&D project initiation, planning, and follow-up; assisted in the resource allocation and coordination of different projects in the process of product development and organised the team to tackle key technical problems;
2. Participate in the cooperative scientific research projects between the company and clinical research institutions, undertake the relevant experimental tasks in the cooperative projects, and participate in the writing and revising scientific research papers.
3. Assist in optimising the development process, improving the development system, formulating development standards, standardizing development documents, and being responsible for the efficiency and quality of product development.
4. Independently analyse and summarise experimental data, submit brief reports, and be able to report at project management meetings.
5. Familiar with protein structure, protein biophysical and biochemical characterisation, biochemical assay development, and mammalian cell handling. 

Job Requirements

1. Ph.D. in biochemistry, cell biology, pharmacy, immunology, pharmacology, etc.,
2. Familiar with new drug research and development processes, with rich experience in pre-clinical pharmacodynamic evaluation;
3. Proactive, strong execution, good communication skills, and team spirit.
    

Responsibilities:

1. Support new  R&D project initiation, planning, and follow-up; assisted in the resource allocation and coordination of different projects in the process of product development and organised the team to tackle key technical problems;
2. Participate in the cooperative scientific research projects between the company and clinical research institutions, undertake the relevant experimental tasks in the cooperative projects, and participate in the writing and revising scientific research papers.
3. Assist in optimising the development process, improving the development system, formulating development standards, standardising development documents, and being responsible for the efficiency and quality of product development.
4. Independently analyse and summarise experimental data, submit brief reports, and be able to report at project management meetings.
5. Familiar with mammalian cell culture, cell engineering, and cell characterisation by flow cytometry, fluorescent microscope, and various cell and animal models. 

Job Requirements:

1. Ph.D. in biochemistry, cell biology, pharmacy, immunology, pharmacology, etc.,
2. Familiar with new drug research and development processes, with rich experience in pre-clinical pharmacodynamic evaluation;
3. Proactive, strong execution, good communication skills, and team spirit.

About Cerecin

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin’s development program leverages its extensive experience in neurology drug development and lipid science. Cerecin is supported by two multinational partners, Nestlé S.A. and Wilmar International Limited. By bringing together the deep expertise of its leadership team and a highly differentiated drug development program, Cerecin is becoming a global leader in neurology therapeutics.

Position Overview

• Oversee and manage all data management (DM) activities for studies from start-up through database closure and archival, producing high quality databases for analysis and potential regulatory submissions.
• Deliver Data mining services and solutions in support of Clinical Management Capabilities for the organisation
• Advise on and deliver Data Architectures pertaining to existing and ongoing Clinical initiatives

Key Accountabilities

Data Operational Oversight

• Data Operations lead for all meetings and communications as part of the clinical project team on overall Data Operations strategy for the project to assure data quality and efficiency
• Represent DM as the functional lead at internal clinical leadership meetings.
• Assumes ownership for DM related project deliverables including creation and management of DM-specific timelines and providing resource and budget projections
• Provides timely operational communications of project status, data trends and issues, with appropriate remediation and resolution.
• Develops, generates and analyses project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management and project team
• Provides and/or reviews staffing projections for DM activities for assigned programs and ensures the timely and appropriate assignment of outsourced DM capabilities.
• Proposes process or system improvements for global implementation and participates in development and implementation
• Discusses roadblocks to Data Operations deliverables and potential strategies for overcoming with project team and/or Data Operations management and implements solutions
• Represents DM in regulatory and Sponsor audits for assigned study and/or program as well as general qualification audits by Sponsor
• Oversees the DM project and/or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans including but not limited to:
  • Data Reconciliation (e.g. SAE etc ) including resolution and escalation to other internal groups and/or CRO / other contract agencies
  • Investigation and remediation of data issues such as from statistical, programmer, medical monitor or Sponsors.
• Assumes ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures, coordinating with manager for resourcing requirements

System Development and Modifications

• Develops and implements DM strategy on the project/program based on scope of services
• Coordinates with Technical Design and Clinical Programming team as well as Project Managers to develop and maintain DM startup timelines including the development, testing and implementation of all data capture tools
• Coordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelines
• Coordinates with the Technical Design and Clinical Programming team and/or 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirements
• Facilitates project team and Sponsor reviews of system documents including but not limited to Time and Events Schedule, CRFs, Edit Checks, revision specifications
• Consolidates reviewer comments from internal team/sponsor and collaborates with the project and Clinical Programming team, as required, for revisions
• Coordinates with the project team as well as the Technical Design and Clinical programming team to manage post go-live EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and/or projects

System and Data Listing Testing Activities

• Coordinates testing activities for the EDC technologies per scope of services
• Performs testing for EDC systems as required per scope of services and standard operating procedures
• Verifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests
• Provides feedback to the other project team members and managers to improve the deliverables.
• Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as required
• Data review listing specifications

Continuous Improvement and Data Architecture

• Recommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templates
• Serves as Data Operations mentor
• Creates and maintain documentation for templates (DMP, CRF Completion guidelines, Database Design Documents, Edit specifications, Reconciliation guidelines, Report specifications)Trains others on specific departmental processes including database design document creation, edit check creation, change control processes, database lock
• Provides open environment for question/issues about DM topics from within department and cross-functionally
• Collaborates with analytics and business teams to improve data models that feed business intelligence tools, increasing data accessibility and fostering data-driven decision making across the organisation.

Professional Experience

• 8 years’ experience in the biotechnology/pharmaceutical industry in a scientific or clinical role with demonstrated relevant experience
• Strong knowledge of drug development and ICH/GCP guidelines ▪ Strong knowledge of Alzheimer’s disease and other neurodegenerative disorders such as Migraine, Epilepsy
• Knowledge of clinical operations, from protocol concept through clinical study reporting
• Experience with multiple study phases (e.g., Phase I–IV) and IITs

Skills

• Excellent knowledge of clinical trial concepts
• Proficiency with multiple data collection systems including electronic data capture (EDC) technologies such as ePRO or eCOA, IRT (preferred EDC systems are InForm and Rave) will be a bonus
• Proficiency in computer applications and time management tools (e.g., MS Office)
• At least 5 years’ experience of best practices and IT operations in an always-up, always-available data service
• Knowledge of working in a regulated environment and familiarity with PDPA, GDPR, ICH-GCP regulations a plus
• Working SQL knowledge and experience working with relational databases for storage and management of Clinical Data

Education

• Minimum MSc. Hands on experience in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related data also required.
• Proven competence in managing delivery of multiple global projects/programs independently through full data management study life-cycle, including large and/or complex trials
• Equivalent combination of education, training and experience

About Cerecin

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin’s development program leverages its extensive experience in neurology drug development and lipid science. Cerecin is supported by two multinational partners, Nestlé S.A. and Wilmar International Limited. By bringing together the deep expertise of its leadership team and a highly differentiated drug development program, Cerecin is becoming a global leader in neurology therapeutics.

Position Overview

The Clinical Project Manager is responsible for management of multiple projects conducted within the Clinical Department and for communication of information about those projects to management and other stakeholders, as appropriate. The Clinical Project Manager will work collaboratively within the company and with CROs/vendor partners to plan and execute clinical trials. The Clinical Project Manager plays a key role in working with the study team to capture, analyse and report metrics on trial performance and adherence to plans (e.g., timelines, enrollment, data cleaning progress, budget metrics, etc.).

Activities may include, but are not limited to: protocol and clinical study report development, vendor selection processes and vendor management, forecasting of clinical trial material or other supply needs, development of IWRS and/or EDC system specifications, development and management of timelines, project plans and budgets, study metrics reporting, development of study risk management and quality plans, involvement in investigator selection processes, etc. The Clinical Project Manager may also manage or participate in certain day-to-day clinical trial activities (e.g., review and tracking of monitoring reports, clinical quality activities, review of site regulatory packets, review of data listings, quality review of other clinical/regulatory documents, participation in study recruitment initiatives, occasional co-monitoring with CRO staff, etc.) and will engage with cross-functional team members, vendor partners and clinical sites to ensure that trials are conducted in a manner that is timely, aligned with company goals, and in accordance with applicable standard operating procedures (SOPs) and applicable regulatory guidelines (e.g., ICH/GCP, etc.).

Key Accountabilities

• Responsible for planning, executing and successful completion of clinical research activities for clinical trials, including Phases I – IV and Investigator-initiated trials (IITs)
• Responsible for collating study metrics, developing and maintaining a comprehensive dashboard that is reported regularly to management and other stakeholders
• Work collaboratively with other members of the Clinical Operations team and/or CROs and vendor partners to establish and maintain study timelines, develop and maintain study risk management plans, communication plans, project plans etc.
• Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, ICH guidance, and internal Standard Operating Procedures. This may include contributions to and management of site Corrective and Preventative Action Plans (CAPAs), periodic co-monitoring visits with CRO personnel, and participation in site and/or vendor auditing
• Coordinate the completion of clinical and regulatory documents such as Clinical Trial protocols, Investigator Brochures, Clinical Trial Applications, etc. Write sections as directed. Perform and document quality review of these documents as needed
• Conduct study operational feasibility and risk assessments, identify issues, summarise findings and recommend course of action or course corrections and mitigation plans, as appropriate. This includes oversight and tracking of study timelines and progress and appropriate escalation of issues
• Work cross-functionally with other departments to forecast and maintain adequate clinical trial material or other study supplies
• Prepare study budgets. Manage the study to budget. Interface with Finance and Accounting Department regarding contract services to review invoices for accuracy and adherence to contracts, track payments made to service providers, and to contribute to the development of study-specific budgets and tracking tools
• Work with other members of the Clinical Operations team to accomplish corporate, departmental and project-specific goals and help manage day-to-day study operations (e.g., site regulatory packet review, monitoring report review, review and tracking of invoices, data listing review, development of study-specific plans, etc.)
• Ensure that proper study documentation is in place and that study issues are appropriately escalated to management, as needed
• Ensure development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development. Actively participate in bid defense, vendor selection and contract finalisation meetings
• Responsible for the management of Clinical Research Organisations (CROs), and other service providers, and serve as the primary liaison between the company and the external team members.
• Oversee planning of investigator meetings with vendor partners; participate in the presentation of operational information
• Develop or review and provide feedback on all study plan documents including project management, safety management, monitoring, data management and statistical analysis plans
• Manage vendors according to scope, budget and adherence to contract. Ensure any change orders are vetted with management and in place with the vendor prior to engaging in out-of-scope work
• Assure proper study documentation is maintained and archived in the Trial Master Files. Periodically review eTMF and liaise with vendor partners to ensure inspection readiness. Work with vendor partners to properly document and archive files at study closure
• Ensure that studies are entered and updated within required databases and registration systems such as Clinical Trials.gov
• Manage post-market safety surveillance processes and requests for medical information, as necessary

Skills

• Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organisational skills, communication and quality orientation
• Proven interpersonal, written and verbal communication and organisational skills
• Proven ability as an effective leader (e.g. training, decision-making, problem-solving, negotiating etc.)
• Commitment to teamwork
• Ability to work in ambiguous situations and make appropriate course corrections
• Ability to utilise various electronic systems and software- intermediate computer skills required. Facility with MS Office applications is a must, particularly Excel, and familiarity with MS Project are preferred.
• Ability to travel as needed for investigator meetings, vendor auditing and oversight, internal team meetings etc.

Education

• MSc in scientific disciplines/life sciences (Pharmacology, Toxicology, Biology, Biochemistry, Physiology, Nursing, or closely related discipline)

About Cerecin

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin’s development program leverages its extensive experience in neurology drug development and lipid science. Cerecin is supported by two multinational partners, Nestlé S.A. and Wilmar International Limited. By bringing together the deep expertise of its leadership team and a highly differentiated drug development program, Cerecin is becoming a global leader in neurology therapeutics.

Key Accountabilities

• Writing clinical and regulatory documentation including clinical study reports, protocols, informed consent forms, annual reports, investigator brochures, integrated summaries, safety updates
• Review and QC of clinical and regulatory documentation
• Development of slide decks covering study data as well as research data
• Oversight of CRO-produced documentation
• Perform literature searches, summaries and present information
• Participate in study team meetings and ensure all medical writing deliverables are met
• Co-ordinate input cross-functionally for summary documentation

Professional Experience

• Minimum 2 years as a Medical Writer in a pharma or CRO environment
• Therapeutic area experience in neurology preferred
• Excellent understanding of clinical trials, interpretation and presentation of clinical data
• Strong Word, Excel, PowerPoint skills

Education

• MSc in Life Science or Pharmacy
• PhD preferred

About Cerecin

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin’s development program leverages its extensive experience in neurology drug development and lipid science. Cerecin is supported by two multinational partners, Nestlé S.A. and Wilmar International Limited. By bringing together the deep expertise of its leadership team and a highly differentiated drug development program, Cerecin is becoming a global leader in neurology therapeutics.

Key Accountabilities

At the Project Level

• Planning the Project: Defining the project’s scope, determining what resources are available/needed, estimating time and financial commitment, goals of the project, intended outcome/deliverable(s), as well as how to monitor and report on the project’s progress (metrics).
• Assembling and Leading the Project Team: Create team from available resources, assign roles/functions/tasks to team members, ensure understanding and alignment on goals and deliverables, provide team members with parameters/expectations (in terms of time, cost and quality), ensure team members have necessary tools to complete project and to collaborate, ensure communication within the team and without (to key stakeholders), and lead the team in all other ways to ensure success of the project.
• Ensure integration amongst team members for overall project success: ensure integration between the various functions (clinical, regulatory, CMC, non-clinical, commercial, quality, finance).
• Budgeting Activities: Coordinating the development of aligned functional and project budgets, tracking actual spend.
• Quality and Satisfaction: Ensuring quality delivery of project according to stakeholder expectations and communicating with stakeholders during the life cycle of the project. 
• Managing Issues and Risk: Predict, mitigate and manage risks. Implement and manage change when necessary to meet project outputs.
• Monitoring Progress: measure progress and compare against metrics determined in the planning stage. Adjust to keep project on track or to realign. Evaluate and assess result of project.
• Reporting and Documentation: Present to stakeholders reports on progress as well as problems and solutions.

At the Portfolio level

• Management and control of the delivery of multiple concurrent projects.
• Delivery strategies which maximise project revenues, minimise costs, and ensure customer satisfaction.
• Management of the full project life-cycle from beginning to end.
• Determining the scope, deliverables and acceptance criteria for projects.
• Obtaining stakeholder buy-in to project plans and programmes of change.
• Plans and project timelines and milestones using appropriate planning tools.
• Development of MS project plans and associated project documentation.
• Working with resource managers, other Idox departments and 3rd parties to identify and schedule project resources.
• Supervise and motivate resources involved in project deliveries in a matrix-management structure to ensure quality and consistency.
• Tracking project costs so as to complete implementations within acceptable budget tolerances.
• Effective and regular communication with internal and external project stakeholders.
• Delegation of tasks and responsibilities to appropriate personnel.
• Resolution of issues and conflicts within projects.
• Delivery of progress reports, proposals, requirements documentation, and presentations.
• Ensuring project acceptance criteria and invoicing milestones are understood and agreed by the customer throughout project life cycle.
• Proactively manage changes in project scope, identify and address issues, and devise contingency plans.
• Identification and management of project risks, dependencies, deliverables and milestones along a critical path.
• Ensuring smooth transitions to business-as-usual at project completion.
• Management of all financial aspects of the projects including customer invoicing and project costs.
• Establishing strong customer relationships through regular communication, on and off site.
• Documentation and communication of project lessons to support a culture of constant learning.
• Oversees strategic plan, monitoring and adapting as needed.
• Maintains knowledge of larger landscape and strategy without neglecting granular details while tracking project health, staying alert for risk and resolving issues as they arise.
• Maintains standards across projects.
• Participate with senior leadership to establish strategic plans and objectives and prioritisation amongst projects.
• Identify staffing needs/organisational changes as appropriate to meet company projects.
• Work closely with CFO and VP finance to budget for projects.
• Work closely with heads of individual functions to ensure that each project is adequately resourced, budgeted and completed with required quality level

Professional Experience

• 3-5 years’ experience in biopharma as a cross-functional project manager
• Experience in strategic planning, risk management and change management
• International biopharma experience

Skills

• Proficiency in project management software tools (MS Project, Visio, Excel, etc.)
• Proficiency in spoken and written English
• Proficiency in MS Office software
• Able to travel within Asia and globally

Education

• MSc in a relevant field
• PMI certified (or equivalent)

About Cerecin

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin’s development program leverages its extensive experience in neurology drug development and lipid science. Cerecin is supported by two multinational partners, Nestlé S.A. and Wilmar International Limited. By bringing together the deep expertise of its leadership team and a highly differentiated drug development program, Cerecin is becoming a global leader in neurology therapeutics.

Position Overview

This position supports the scientific conduct of clinical studies and programmes and has responsibilities including, but not limited to:

Key Accountabilities

Scientific Oversight of Studies (50%)

• Provides clinical science research expertise, especially study design and data interpretation to achieve high quality protocol development and execution
• Works closely with the study team on the conduct of clinical studies including data management deliverables, preparation of meeting materials, safety and medical monitoring, vendor selection, management & oversight, and analysis and interpretation of study data
• Presents and participates in headline results process providing input, analysis and interpretation of the data
• Presents and reviews clinical documentation including protocols, SAPs, clinical study reports, publications

Medical Writing (20%)

• Manages and oversees medical writing resources as applicable, ensuring deliverables are according to required standards and timelines
• Manages the Investigator Brochure update
• Authors and co-ordinates input of clinical study and regulatory documentation such as protocols, CSRs, internal scientific documents according to required ICH and regulatory standards
• Present, reviews, provides input, clinical study documentation written by 3rd parties

Investigator-initiated Trials (IITs) (10%)

• Assess potential IIT approaches
• Manages the IIT proposal review and approval procedures
• Manages the set-up and oversight of IITs including contracting, IMP supply, budgeting, status updates, and reporting

Clinical Development Strategy (10%)

• Working closely with the VP of Clinical Operations, Director of Biostatistics, Chief Medical Officer, drives the clinical development plans
• Develops subject matter expertise of study methodologies, results, and development plans of other companies and relevant compounds and therapeutic area expertise in the field
• Presents and Leads interactions with external thought leaders and KOLs to help formulate clinical strategies and development plans
• Collaborates with other functions (Regulatory, Commercial, Operations) to achieve corporate goals

Clinical Project Management (10%)

• Work collaboratively with other members of the Clinical Operations team and/or CROs and vendor partners to establish and maintain study timelines, develop and maintain study risk management plans, communication plans, project plans etc.
• Ensure that clinical trials are conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, ICH guidance, and internal Standard Operating Procedures. This may include contributions to and management of site Corrective and Preventative Action Plans (CAPAs), periodic co-monitoring visits with CRO personnel, and participation in site and/or vendor auditing
• Prepare study budgets. Manage the study to budget. Interface with Finance and Accounting Department regarding contract services to review invoices for accuracy and adherence to contracts, track payments made to service providers, and to contribute to the development of study-specific budgets and tracking tools
• Work with other members of the Clinical Operations team to accomplish corporate, departmental and project-specific goals and help manage day-to-day study operations (e.g., site regulatory packet review, monitoring report review, review and tracking of invoices, data listing review, development of study-specific plans, etc.)
• Ensure that proper study documentation is in place and that study issues are appropriately escalated to management, as needed
• Ensure development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development. Actively participate in bid defense, vendor selection and contract finalisation meetings
• Responsible for the management of Clinical Research Organisations (CROs), and other service providers, and serve as the primary liaison between the company and the external team members.

Other Responsibilities

• Interacts with internal and external stakeholders (study sites, committees, experts, vendors) in support of clinical development objectives
• Assists the medical team and study team with the conduct of clinical studies including for example, data management deliverables, preparation of meeting materials, safety and medical monitoring, vendor management & oversight, and analysis and interpretation of study data

Professional Experience

• 8 years’ experience in the biotechnology/pharmaceutical industry in a scientific or clinical role with demonstrated relevant experience
• Strong knowledge of drug development and ICH/GCP guidelines
• Strong knowledge of Alzheimer’s disease and other neurodegenerative disorders such as Migraine, Epilepsy
• Knowledge of clinical operations, from protocol concept through clinical study reporting
• Experience with multiple study phases (e.g., Phase I–IV) and IITs

Skills

• Ability to work with a continued focus on quality, efficiency and ongoing improvement through decision making, planning and organisational skills, communication and quality orientation
• Proven interpersonal, written and verbal communication and organisational skills
• Proven ability as an effective leader (e.g. training, decision-making, problem-solving, negotiating etc.)
• Commitment to teamwork
• Ability to work in ambiguous situations and make appropriate course corrections
• Ability to utilise various electronic systems and software - intermediate computer skills required. Familiarity with MS Office applications is a must, particularly Powerpoint, Excel. Familiarity with MS Project are preferred.

Education

• MSc in a relevant discipline (Pharmacology, Toxicology, Biology, Biochemistry, Physiology, Nursing etc.)
• PhD, PharmD a bonus

About Cerecin

Cerecin is a clinical-stage biotechnology company focused on developing drugs that target the metabolic bases of central nervous system diseases. Cerecin’s development program leverages its extensive experience in neurology drug development and lipid science. Cerecin is supported by two multinational partners, Nestlé S.A. and Wilmar International Limited. By bringing together the deep expertise of its leadership team and a highly differentiated drug development program, Cerecin is becoming a global leader in neurology therapeutics.

Position Overview

The Clinical Statistician is accountable for biostatistical activities and deliverables at Cerecin, and oversees relevant biostatistical activities conducted by contract research organisations (CROs) and contractors. He/She provides direction and oversight on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures the adherence to standard procedures. He/she also provides direct contributions as appropriate to complex statistical analysis plans and interim analysis approaches to gain alignment across the organisation. The clinical statistician builds and maintains strong collaborations with key stakeholders from different disciplines across the organisation to facilitate agile and robust clinical development plans and decision frameworks. He/she represents Biostatistics in meetings with the Cerecin regulatory agencies, advisory boards and external development partners, as appropriate. He/She oversees the relevant biostatistical activities and ensures consistent statistical approaches across teams and external collaborators. He/She also provides leadership on biostatistical approaches including driving process improvement initiatives and enhancing the technical capabilities of the organisation, as appropriate.

Key Accountabilities

• Directs overall statistical activities for the projects assigned including implementing efficient, consistent, and practical processes for Biostatistics and develops, implements and monitors resource allocation and usage for assigned projects
• Provides oversight and guidance for all biostatistical resources in assigned projects to ensure that the project goals are achieved. Assesses and makes recommendations on internal and external biostatistical resources required to execute the project plans.
• Functions as the lead statistician on multiple projects, accountable for the statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity
• Provides guidance and direct input in addressing statistical issues arising from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings and meetings with KOLs
• Participates in and/or leads cross-functional initiatives representing biostatistics. Participates in key internal governance meetings and may represent Biostatistics as appropriate
• Provides guidance and direct input into strategy, planning and contents of clinical development plans, as well as key components of regulatory submissions. Strives to increase the scientific agility through proposal and implementation of innovative approaches and to increase operational efficiency by close monitoring of the operating procedures and strategies for Biostatistics. Serves as the primary functional reviewer of protocols, analysis plans, and clinical study reports
• Maintain industry standards and regulatory requirements for statistical analysis and reporting results. • Support and participate in business development opportunities as part of due diligence activities

Professional Experience

• Substantial past regulatory experiences, including interactions with FDA will be a bonus Experience with EMA, NMPA, MFDS, TGA and/or PMDA is highly desirable.
• Extensive experience working on clinical trials from Phase 1 through to Phase 3
• Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
• Ability to develop innovative/creative statistical/technical solutions to complex problems
• Experience in the design and application of a range of clinical trial designs,  including adaptive designs and phase 2/3 trials
• Knowledge and experienced in meeting regulatory guidance, of both FDA and international regulatory agencies

Skills

• Broad knowledge of medical/biological terminology and clinical trial design in relevant therapeutic areas
• Strong verbal and written communication skills. Able to explain methodology and consequences of decisions in lay terms
• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership
• Strong people manager with track record of staff development and/or significant experience providing oversight of external resources

Education

• PhD or MSc in Biostatistics/Statistics with a minimum of 5-8 years relevant experience

About DotBio
DotBio is a highly innovative biopharmaceutical company with a mission to predict the most effective multi-functional antibody therapies, cancer therapies and derisk the clinical development process. The company generates hundreds of multi-functional antibodies with good developability and screen them in parallel in high-throughput phenotypic assays (HTPAs) against diverse cancers. This combinatorial targeting approach allows to interrogate many immuno-oncology target combinations in parallel, generating a stack of data that can be analysed to identify the most potent and derisked antibodies to move into the clinic.

Job Description:
DotBio is currently looking for a self-driven, dynamic and independent Preclinical Project Manager to join our team. The job will entail overviewing multiple preclinical projects, and interacting with scientists from the antibody discovery and validation teams, as well as CROs and CDMOs to ensure timely execution and reaching the required milestones.

Responsibilities:

• Coordinate R&D team and relevant stakeholders to meet project timelines and deliverables.
• Establish and maintain processes for managing scope, schedule, and budget during the project lifecycle.
• Analyse project status and, when necessary, revise the scope, schedule, or budget to ensure that project requirements can be met.
• Assign and monitor resources to ensure project efficiency and maximise deliverables.
• Establish and maintain relationships with R&D team and relevant stakeholders, providing day-to-day contact on project status and changes.
• Report project outcomes and/or risks to management.

The ideal candidate should have the following attributes:

• Minimum PhD with 1-5 years of relevant working experience in antibody drug development or immuno-oncology.
• Proven working experience with project management in drug development, including antibody drug development.
• Good technical background, with understanding or hands-on experience in antibody drug development.
• Excellent communication and collaborative skills are a must.
• Strong organisation, synthesis and reporting, including attention to detail and multi-tasking skills are required.
• Previous research experience in the immuno-oncology field is a plus.
• Previous experience with project management software is a plus.
• PMP certification is a plus. 

About Genetic Design and Manufacturing Corporation

At Genetic Design and Manufacturing Corporation (GDMC), we aim to bring transformative genetic medicines to patients faster, improving their quality of life. We achieve this by focusing on partnering and supporting early-stage companies and investigator with innovative therapeutic modalities such as gene therapy or mRNA drugs. Leveraging on our expertise in process development and manufacturing, our partner companies can bring their ideas into the market as we work hand in hand with them through clinical trials. We are growing quickly and looking for talented people who are looking out for challenging opportunities to bring transformative medicines and make an impact in people’s lives.

Job Description:
GDMC is expanding our Analytics team and is seeking an exceptional Scientist II. As Scientist II in the Analytics department, you will be developing assays using molecular biology as well as biochemical methods. You will also be exposed to overall process of developing analytical assays and technical transfer to Quality Control. Come join us and be part of our journey to becoming the premier partnership development and manufacturing organisation in Asia Pacific.

Responsibilities:

• Develop and run analytical assays to support GDMC’s programs for plasmid DNA, mRNA and viral vectors.
• Write well-articulated and comprehensive laboratory protocols as well as development reports.
• Collaborate with process development and quality control team.
• General laboratory upkeep, including maintaining laboratory equipment and inventory management.

Job Requirements:

• Masters in Biological Science and Life Science disciplines, Biotechnology, Bioengineering or equivalent. PhD preferred.
• Minimum 3 years prior research experience.
• Experience with molecular biology with experience in cloning, mammalian culture and protein expression.
• Experience with cell line development, media development and viral vectors will be valued.
• Excellent organizational and interpersonal skills.
• Highly motivated, passion for science, committed to laboratory work and able to work flexible hours.
• Ability to multitask, work independently and also as part of a team. Excellent communication (verbal and written) and presentation skills.

GDMC is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to achieving a diverse workforce through application of equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, terminations, salary administration, benefits.

About Genetic Design and Manufacturing Corporation

At Genetic Design and Manufacturing Corporation (GDMC), we aim to bring transformative genetic medicines to patients faster, improving their quality of life. We achieve this by focusing on partnering and supporting early-stage companies and investigator with innovative therapeutic modalities such as gene therapy or mRNA drugs. Leveraging on our expertise in process development and manufacturing, our partner companies can bring their ideas into the market as we work hand in hand with them through clinical trials. We are growing quickly and looking for talented people who are looking out for challenging opportunities to bring transformative medicines and make an impact in people’s lives.

Job Description:
GDMC is expanding our Process Development team and is seeking an exceptional Scientist II. As Scientist II in the Process Development department, you will be developing processes as well as CMC for various modalities. You will also be exposed to new product development in biopharma as well as understand the need for robust processes to create safe and consistent products. Come join us and be part of our journey to becoming the premier partnership development and manufacturing organisation in Asia Pacific. GDMC is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to achieving a diverse workforce through application of equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, terminations, salary administration, benefits.

Responsibilities:

• Support the development and operation of unit operations and manufacturing processes in upstream development or downstream development for plasmid DNA, mRNA and viral vectors as well as perform the experiments for process optimisation.
• Write well-articulated and comprehensive laboratory protocols as well as development reports.
• Collaborate with analytics and quality control team.
• General upkeep of the laboratory, including maintaining laboratory equipment and inventory management.

Job Requirements:

• Masters in Biological Science and Life Science disciplines, Biotechnology, Bioengineering or equivalent. PhD preferred.
• Experience with bacterial or mammalian culture, preferably experience in large scale fermentation and bioreactor operations (for upstream processing).
• Experience with separation and purification of biomolecules, preferably experience in Akta or equivalent chromatographic equipment and TFF.
• Preferred: Experience with nucleic acid or protein analytical techniques.
• Excellent organizational and interpersonal skills.
• Highly motivated, passion for science, committed to laboratory work and able to work flexible hours.
• Ability to multitask, work independently and also as part of a team. Excellent communication (verbal and written) and presentation skills.

GDMC is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to achieving a diverse workforce through application of equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, terminations, salary administration, benefits.

Job description

The fellow will be involved in executing laboratory operations directed towards the application of analytical methods for in-process testing, release, and characterisation of biological products, e.g., performing laboratory testing and generating laboratory data pertaining to the potency of investigative vaccines.

They will conduct routine analytical procedures for in-process control samples and for product release of biologics and biopharmaceuticals such as Mab, recombinant proteins, or vaccines. The fellow will also work closely with process development team, external consultants and contractors for the establishment and technology transfer of analytical methods, and assist in authoring high-quality technical memorandum, protocols, reports, summaries, and quantitative analysis, for the distribution and/or presentation to project teams, and for regulatory agency submissions.

Other key job responsibilities include participating in new product technology transfer, and analytical qualification and validation activities to advance Hilleman’s portfolio pipeline.

Requirements

• Masters or PhD in Biochemical Engineering, Biotechnology, Biochemistry or related Pharmacology disciplines

• Fresh graduates may apply

Job description

The fellow will be involved in the formulation and product development of Hilleman Laboratories pipeline products (including vaccines, mAbs, recombinant proteins).

Responsibilities include development of robust formulation for drug substance and drug product from discovery till phase 2 clinical development; as well as development and supporting technology transfer of scalable and robust drug product manufacturing process to process validation with manufacturing partners. The individual will drive the execution of formulation and drug product development strategies, author technical protocols, design and implement experimentation, generate technical reports, and author related CMC sections to support regulatory submissions. 

The fellow will collaborate closely with Analytical Development, as well as Process Development, Quality Control, Quality Assurance as required. This role may also require interfacing with external contract organisations.

Requirements

• Masters or PhD in Pharmacy, Chemistry, Biology or related Pharmaceutical Sciences
• 2-6 years relevant industry experience.