FRAUD ALERT:

Be aware that we are currently receiving numerous reports of cyber criminals posing as TopAlliance Biosciences Inc. recruiting personnel seeking to engage with job seekers through fraudulent job search sites and email solicitations to conduct sham job interviews and make bogus job offers. Once the innocent job seekers accept the interview and the sham job offers, the scam artists would attempt to obtain the victims’ personal and financial sensitive and identifiable information to financially further victimize the job seekers.  Please know that TopAlliance does not conduct interviews via chat rooms such as Google Hangouts, use apps similar to Signal, charge candidates an advance fee of any kind (for instance, fees for purchasing equipment). Please also note that any correspondence with regard to employment would come from ONLY authorized topalliancebio.com email address and not from a topalliancebiocareers.com email address as has been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from anyone using the topalliancebiocareers.com email address, do not respond to it and do not open any attachments or click on any hyperlinks.

Current Openings (U.S. Operations)

Position Title: Database Administrator

Location: Rockville, Maryland

Workplace Type: On-site

Summary: We are looking for an in-house Database Administrator who is capable of making strategy around scientific database management solutions for internal teams in pre-clinical R&D, clinical and QA. Our ideal candidate is someone who can maintain and improve our company’s database systems, respond to database related software/hardware/network issues in both an office and a laboratory setting, build and manage the company’s database system, and assist with lab database software installation and management in compliance with pharma/biotech regulations and SOPs. This role requires you to be present on-site.

 

Responsibilities

  • Manage and analyze the performance of clinical and biotech database systems including Laboratory Information Management System (LIMS), cloud-based database system, local server system;
  • Develop code to auto-capture articles from FDA open-source database, analyze data and build database for different functions; Work with software engineering consultant at California site to build server automation pipeline and database storage and analyze the system performance metrics;
  • Evaluate and set up hardware, software and network based on the needs and requirements of the company’s database systems, and provide necessary trainings to employees;
  • Develop computer and information security policies and SOPs and implement security measurement tools to protect database in compliance with the current GxP guidelines.

Minimum Qualifications

Education:

  • Bachelor’s degree in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, Information Technology or related field.
  • A Master’s degree in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, Information Technology or related field is preferred.

Required:

  • Skills in programming languages (SQL, Python, MATLAB, C/C++, etc.), database systems management, operations analysis, systems evaluation and analysis.
  • Rudimentary lab skills and a basic understanding of lab equipment, especially in relation to instruments that communicate directly with computers and software applications
  • Working knowledge of common office software (Microsoft Teams, Adobe, SharePoint, etc.)
  • Good organization, time management and prioritization
  • Effective communication skills

Please email a cover letter and resume to jobs@topalliancebio.com, attn: Emily Xu

Current Openings (U.S. Operations)

(Senior) Clinical Research Scientist

Position Type: Full-time

Location: Rockville, MD

Immediate Supervisor: Senior Medical Director/ Medical Sciences/Chief Medical Officer

 

Summary: The Clinical Research Scientist is responsible for oversight of a single or several smaller clinical development programs, a single complex/novel study such as platform or basket trial, or as a member of the medical science team for a global trial, with primary responsibilities for drug development in clinical sites outside of China. The scope will differ depending on the exact nature of the clinical program. The Clinical Research Scientist also provides expert input to improvement projects to enhance the overall clinical development program.

 

Responsibilities

  • Evaluate pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications;
  • Provides advice on clinical development strategies for investigational drugs for treatment of cancer at clinical sites outside of China (primarily in the U.S. and Europe) in the context of the overall global development program; closely coordinates with peers in China on global development strategies; and reviews and assesses new information on competitive drug development to assess risks to development strategies and integrates emerging data into drug development plans;
  • In conjunction with CMO and/or Senior Medical Director, liaises with the internal and external medical community (e.g., Key External Experts (KEEs), Key Opinion Leaders (KOLs), Advisory Boards) to follow developments within assigned therapeutic area(s);
  • In conjunction with CMO and/or Senior Medical Director, designs clinical trials (study design, clinical operation plans, exploratory biomarker assessments) for the US and globally, based on the proposed clinical development strategies;
  • Provides input in therapeutic area(s) for project or study level documents, including but not limited to the clinical development plan, clinical study protocol, and clinical study reports to ensure compliance with GCP and applicable regional regulations as well as ensuring the scientific integrity of individual studies and the development program;
  • Monitors and manages the conduct of clinical trials for investigational drugs for the treatment of cancer outside of China (primarily US and Europe);
  • Develops strategies for, or drafts initial regulatory response to, complex technical issues for specific medical aspects on current projects, new projects and the broader therapeutic area; leads medical aspects of regulatory communications (written and verbal) for investigational drugs and marketing applications.
  • Conducts analyses of efficacy, safety, and biomarker data from clinical studies to support clinical protocol modifications or other decisions throughout the development program and summarizes clinical findings in support of investigator/safety review committee meetings, clinical study reports, new drug or biologics license applications, and publications;
  • Participates in research project teams on the development of investigational drugs and the further study of marketed drugs.
  • Works closely with a cross-functional group of experts in regulatory affairs, clinical operations, statistics, clinical pharmacology, translational assays, nonclinical toxicology and manufacturing, as appropriate, to manage clinical development projects. Coordinates with counterparts in China on global clinical development programs. Assists the Senior Medical Director in ensuring that appropriate company personnel are informed of the progress of studies for TopAlliance and of competitors’ drugs. Provides internal and external input and recommendations on scientific questions relevant to his/her areas of responsibility.
  • Authors detailed development documents, presentations, and position papers for internal and external audiences
  • Facilitates collaborations with external researchers
  • Participates in conference calls approximately up to two times per week that may occur outside of normal business hours and may travel up to five (5) percent of the time to manage future or ongoing clinical research projects.

 

Minimum Qualifications

Education:

  • M.D. or M.D./Ph.D.

Required:

  • Minimum of 3 years of clinical medicine experience
  • Minimum of 3 years of experience in the field of drug development or biomedical research
  • Strong interpersonal skills, as well as the ability to function in a team environment are essential.

Preferred:

  • Prior specific experience in the conduct of clinical research studies, including preparation of documentation for and presentation to, regulatory health authorities

Please email a cover letter and resume to jobs@topalliancebio.com, attn: Emily Xu

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