Position Location: Menlo Park, California

Position Description:

We are seeking a highly motivated individual to support NGS pipeline development and data analysis for clinical studies, translational and pre-clinical research. The successful candidate will apply advanced bioinformatics and statistical skills to develop and maintain NGS pipelines, process high-dimensional genomic data, and build statistical & machine learning models for NGS data derived from clinical development programs and translational research.

Expectations:

• Drive the design, the development, and the maintainence of end-to-end bioinformatics pipelines to work with multi-omics sequencing data from FFPE tissue to liquid biopsy samples
• Lead the development of novel statistical and machine-learning based methods to optimize detection of mutations, copy number alterations, genomic rearrangements, HLA, and oncovirus.
• Lead and perform benchmarking for testing pipeline accuracy and performance.
• Interact with key internal stakeholder and external investigators for data processing, analysis, and interpretation.
• Collaborate with translational bioinformatics scientist to facilitate biomarker analyses of NGS data from clinical trials and translational research.

Skills and qualifications:

• Experience in managing cross functional team members during trial execution a must.
• Strong knowledge of ICH/GCP guidelines with working knowledge of GLP/GCLP preferred.
• Ability to function in a fast paced, dynamic environment.
• Ability to independently develop and deploy action plans to meet company needs.
• Strong interpersonal and negotiation skills.
• Proven complex problem solving and decision-making skills.
• Must be a demonstrated self-starter and team player with strong interpersonal skills
• Excellent written and verbal skills.

Qualifications:

• PhD in Bioinformatics, or Computational Biology, Computer Science, Biostatistics or related field or equivalent work experience
• 2+ years of experience in working with whole genome sequencing, whole exome sequencing, bisulfite sequencing, and whole transcriptome sequencing data
• Experience with standard bioinformatics algorithm and tools, such as BWA, GATK
• Experience with statistical and machine learning techniques, such as linear regression, random forest, bayes inference, etc.
• Proficiency in Python, R, and Linux shell scripting language

Position Location: On-site

Position Description: This position is broad, and include the responsibility for ensuring the delivery of all laboratory activities through external partners, meet internal and external quality and regulatory standards all whilst using your operational expertise to advise clinical teams on operational lab strategy, development and deployment.  You will regularly be involved in providing advice to clinical teams on laboratory related documentation, operational design and new ways of working, as well as managing external providers to oversee the delivery of relevant lab services and data. It is imperative that TopAlliance Biosciences employees/contractors embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives

Overall Strategy:

• Interface with medical leadership, clinical operations and bioanalytical teams to develop and implement an overall clinical trial strategy for collection, tracking, and management of clinical trial samples and related information.
• Identify novel and innovative clinical sample collection techniques and ensure operational delivery of clinical laboratory testing.
• Setup, deploy, and manage Laboratory Information Management System LIMS), or other relevant sample management database as it pertains to sample and data management .
• Develop sample management related oversight plans and contribute to process improvement initiatives as needed.

Study Specific deliverables:

• Provide input into clinical trial protocols/synopses and informed consent forms to ensure logistical feasibility of clinical sample strategy as well as alignment with all Clinical Sample Plans, ICH/GCP, and local regulations.
• Contribute to the analytical laboratory vendor selection process and, in collaboration with applicable clinical and laboratory team members, assist in the execution and implementation of vendor contracts as needed.
• Weigh in on clinical trial feasibility to support collection and assessment of regional and site-based laboratory capabilities.
• In collaboration with clinical operations and external partners, develop and deploy the clinical sample management plan(s) and all trial related tools (laboratory manuals, database development, kit development, templates, regimens, rosters, etc.)
• Oversee clinical sample chain-of-custody activities and ensure all laboratory related vendor activities are in line with the sponsor/laboratory contract and scope of work.
• Partner with bioanalytical team to ensure the delivery of clinical sample data is in accordance with study timelines.
• Serve as primary point of contact for clinical sample management related items, monitor vendor performance and communicate study specimen updates and/or any sample management, tracking, or compliance related issues to study stakeholders.
• Advise and support internal and external guidelines for US and ex-US sample shipment.
• Advise and support internal and external guidelines/best practices for sample handling.
• In partnership with the Clinical Trial Manager ensure adequate Clinical Research Organization (CRO) and site training and guidance is incorporated into the clinical trial training plan and all applicable site training materials.
• In collaboration with the Clinical Trial Manager, ensure all required clinical sample deliverables are managed to completion at study closure, including execution of any final data reconciliations, transfers, or issue resolution as required as part of database lock (DBL).
• Provide budget forecasting related to clinical sample management as needed.
• Process vendor invoices as required.

Skills and qualifications:

• Experience in managing cross functional team members during trial execution a must.
• Strong knowledge of ICH/GCP guidelines with working knowledge of GLP/GCLP preferred.
• Ability to function in a fast paced, dynamic environment.
• Ability to independently develop and deploy action plans to meet company needs.
• Strong interpersonal and negotiation skills.
• Proven complex problem solving and decision-making skills.
• Must be a demonstrated self-starter and team player with strong interpersonal skills
• Excellent written and verbal skills.

Experience:

Required

• 5 year(s): clinical sample management work experience or equivalent

Preferred

• Working with laboratories
• Batching Strategy
• ICH/GCP
• Experience with LIMS, or other relevant sample and data management databases

Education:

• Preferred BA/BS in Health Sciences or relevant discipline

Position Location: On-site/Remote

Position Reports To: Executive Director, Clinical Operations

Position Description: The Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out activities. This position will perform required job duties with guidance to ensure the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.

Essential Responsibilities:

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, service providers, and consultants that are involved in a clinical trial
• Coordination of cross-functional internal and external study team members (biostats, clinical pharmacology, data management medical monitors) to ensure initiation and execution of the clinical study deliverables within approved budget and timelines
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
• Assist in preparation and review of clinical documentation such as protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, case report form, statistical analysis plan, clinical study reports, and other study level documents
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
• Participate and respond to Quality Assurance and regulatory authority inspection audits Responsible for and participates in service provider selection process as a part of outsourcing activities.
• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
• Manage clinical trial budgets, providing ongoing financial reporting and projections Perform and manage data review process on an ongoing basis
• Negotiate and finalize site contracts and budgets
• Perform site visits including oversight, site qualification, initiation, monitoring and close-out visits, as needed
• Plan and coordinate Investigator Meetings
• Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished
• Awareness of disease / treatment landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
• Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials

Qualifications:

• Demonstrated experience in core and technical aspects of initiating and managing phase 1-3 clinical trials
• Demonstrated experience in management of CROs and vendor selection
• Demonstrated willingness to be hands-on and perform tasks within tight turnaround time
• Possessing excellent interpersonal and communication skills, with developing leadership attributes
• Demonstrated experience in the application of US and Global Regulations and Guidance (SOPs, ICH-GCP, FDA-CFR, ethical standards)
• Experience in data collection, monitoring, cleaning and analysis throughout clinical development (phase 1-3)
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook), electronic TMF, and electronic clinical technologies
• Able to multi-task in a fast-paced environment
• Able to build strong cooperative relationships with coworkers
• Author complex documentation with minimal supervision
• Possess a high degree of attention to detail
• Previous employment at a pharmaceutical or biotech company or CRO

Education:

• Bachelor’s Degree, Master’s Degree or higher in science, nursing, medical field, or business management. An Associate’s Degree /RN or equivalent with relevant years of experience is acceptable.
• Typically an average of 6+ years in the pharmaceutical industry is required, including but not limited to 2 years overseeing trial management.

Language skills:

• Superior written and spoken communication skills in English
• Ability to clearly communicate complex issues, observations and resolutions to management

Reasoning ability:

• Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions
• Work on complex problems where the analysis of situations or data requires in-depth evaluation and propose possible solutions
• Work with minimal supervision both independently and as part of a team
• Proactively foresee and solve problems and commit to a high level of service

Position Location: On-site/Remote

Position Reports To: Head of Biostatistics

Essential Responsibilities:

• Collaborate with Medical Science in preparation of clinical trial development plans with respect to the study design, particularly the study objectives, endpoints, sample size, stratification and randomization
• Review protocol and author statistical sections
• Review CRF design and external data specifications to ensure protocol objectives are met and project standards are maintained
• Develop statistical analysis plan and independent data monitoring charter
• Prepare the study randomization and participate in its implementation
• Organize data monitoring meetings
• Work closely with Statistical Programmers in dry runs, identify data quality issues for key efficacy and safety variables, and ensure high quality of final TFL’s
• Review & author the clinical study report
• Support NDA/BLA by overseeing the generation of health authority submission datasets, outputs, and performing ad hoc analyses as needed
• Oversee the statistical deliverables from CROs
• Contribute to study publications and presentations.
• Participate in process improvement/development activities for standards, process, and guidelines

Qualifications:

• PhD (or Master) in Statistics, Biostatistics, or other statistics-related majors (3+ years of experiences in pharmaceutical industry for master’s degree)
• Accomplishment of responsibilities with appropriate supervision
• Good problem-solving and critical thinking skills, ability to drive drug development strategies
• Effective communication and collaboration skills: including statistical consulting skills and interpersonal skills to contribute effectively in cross-functional team settings
• Rich experiences in using statistical software such SAS and R
• Good knowledge of statistical concepts and methods that are commonly used in the drug development
• Good understanding of regulatory guidelines

Language skills:

• Superior written and spoken communication skills in English
• Ability to clearly communicate complex issues, observations and resolutions to management

Reasoning ability:

• Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions
• Work on complex problems where the analysis of situations or data requires in-depth evaluation and propose possible solutions
• Work with minimal supervision both independently and as part of a team
• Proactively foresee and solve problems and commit to a high level of service

Position Location: On-site/Remote

Position Reports To: Head of US regulatory affairs

Position Description: 

As an associate director/director of regulatory affairs (RA) in Rockville, MD, you will play a critical role in developing innovative drugs that provide patients with treatment options that work better and cost less.

Reporting to the head of US regulatory affairs, the associate direct/director of regulatory affairs is an experienced regulatory professional with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of regulatory deliverables such as INDs, BLAs, and meeting packages, etc. The role is a key contributor to lead regulatory applications and managing procedures through approval. This person is also an integral part of the regulatory affairs team in establishing and implementing procedures and processes for regulatory affairs within the company. This person is expected to work with various cross-functional teams (clinical, nonclinical, CMC, and commercial) and external vendors to ensure the delivery of objectives.

Essential Responsibilities:

• Lead the planning, preparation (including authoring where relevant), and delivery of both IND and BLA submissions throughout the product’s life cycle from pre-IND to BLA approval.
• Identify regulatory risks and develop corresponding mitigation plans with cross-functional teams.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to all relevant parties.
• Serve as the point of contact between RA and internal/external stakeholders for the specified projects
• Work with head of RA to develop and establish appropriate procedural and process flows
• Coach, mentor and knowledge share within the RA group

Qualifications:

• Strong project management skills
• 5 to 7 years of experience or equivalent of regulatory drug development including product approval/launch.
• Extensive regulatory experience within the biopharmaceutical industry or at a health authority
• Thorough understanding of drug (biologics) development process
• Ability to lead multi-disciplinary project teams without authorities
• Prior experience working on original BLA or BLA supplement is a plus

Education:

• Bachelor’s Degree, Master’s Degree or higher in science and related field
• A RAC certification is “nice to have” but not required

Language skills:

• Superior written and spoken communication skills in English
• Ability to clearly communicate complex issues, observations and resolutions to management

Reasoning ability:

• Exercise judgment within broadly defined procedures and policies in selecting methods, techniques, and evaluation criteria for obtaining solutions
• Work on complex problems where the analysis of situations or data requires in-depth evaluation and propose possible solutions
• Work with minimal supervision both independently and as part of a team
• Proactively foresee and solve problems and commit to a high level of service