(Part-time/full-time negotiable, depends on profile of the candidates.)

Location: Boston or New Jersey or California is preferable, depends on profile of the candidates.

RESPONSIBILITIES

● Generating leads through searching prospective clients or networking, including local and global pharmaceutical and biotech companies.

● Identifying new potential customers, developing and nurturing relationships with key customer accounts.

● Keeping up with the latest market and industry developments, including market positioning of corporate competitors.

● Negotiating with clients regarding pricing and contracts to promote the implementation of the projects.

● Assessing client needs and Company's ability to meet those needs.

● Contributing to Company's business strategy and direction discussion.

QUALIFICATIONS

● Years of Experience: 10+ years' working experience in relevant industry, working experience in CRO or pharmaceutical, biotech industry is 

    mandatory. Familiar with Sponsors and their pipelines of product development.

● Knowledge: Deep understanding of clinical development processes, preferred knowledge in clinical operations and/or Clinical Statistical 

    Programming, Clinical pharmacology, regulatory affairs.

● Competency: Strong network in biotech and biopharma; Strong communication skills; Strong presentation skills; Keen business sense and strong 

    understanding of client psychology; Ability to work independently and as a team member; Fast learner.

● Education: Bachelor or advanced degree in life science, marketing, statistics or pharmacy related is preferred.

RESPONSIBILITIES

● Responsible for the planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics 

    pharmacodynamics, exposure response, and disease progression modelling.

● Conduct simulations to inform drug development decisions such as dosage regimen selection and other trial design features.

● Provide Quantitative Clinical Pharmacology expertise on multidisciplinary development teams, working closely with clinical pharmacologists, 

    clinicians and statisticians to participate in writing project documents (e.g. Clinical Development Plan, Investigator Brochure, NDA documents).

● Interact on a scientific level with partners in project team(s) with regards to all aspects of the application of M&S to ensure efficient and 

    appropriate integration of M&S strategy and results into internal and external project documents (e.g. Clinical Development Plan, Investigator 

    Brochure, NDA documents)

QUALIFICATIONS

● MD, PharmD or PhD (in natural sciences, mathematics, physical sciences or engineering or any combination of these) with at least 5-year 

    experience in Pharmacometrics, Clinical PK/PD and/or Clinical Pharmacology.

● Strong quantitative modelling skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modelling/systems pharmacology, literature 

    meta-analyses, clinical trial simulations, statistics).

● Significant experience with Modeling & Simulation software (e.g. NONMEM, Monolix, Phoenix, MATLAB, Gastroplus, Simcyp, SAS, R,…)

● Efficient written and oral communication.

RESPONSIBILITIES

● Responsible for writing, editing medical and regulatory writing, covering clinical research design, or the submission to regulatory agencies or 

    Ethics committees, including the clinical study reports, create summary or changes, study protocols, etc;

● Work with teams and conduct literature searches, and evaluate and analyze the presented data;

● Ensures deliverables are in accordance with regulations, standards, and guidelines;

● The regulatory documents that the Medical Writer prepares must meet ICH, GCPs guidelines, and the clinical writing style guide;

● Understand the levels of evidence required to achieve regulatory, clinical assessment goals;

● Coordinate the review, approval, internal quality control. Resolve document content issues and questions arising during the writing process;

● Proactively identify and implement of the process improvements.

QUALIFICATIONS

● Master degree at least, graduated in clinical medicine, public health or related majors, and at least 5 yrs of experience in clinical research field;

● Minimum of 2 years of regulatory document project management experience in working with collaborative, cross-functional teams;

● Extensive knowledge of a standard literature wiring style guide;

● High-level content writing experience and experience with clinical development regulatory documents (especially for FDA submission 

    documents), with working knowledge of statistical concepts and techniques;

● Knowledge in CMC and toxicology is a plus;

● Excellent written and oral communication skills;

● Ability to communicate scientific or medical information in a clear and concise manner;

● Familiarity with the principles or guidelines of clinical research;

● Ability to interpret and present clinical data and other complex information;

● Collaborative, ability to influence and cross functionally to reach qualified deliverables.

RESPONSIBILITIES

● Provide medical safety review to studies for safety related matters, including protocols, IBs, and other safety documents;

● Collaborate with PV operation team with regards to ICSR processing: provide medical support to PV operation team, whenever guideline is 

    needed;

● Conduct signal detection and evaluation for assigned projects;

● Conduct risk management activities, including 1) Identify and evaluate the safety risks in clinical trial. 2) Generate risk management plan. 3) 

    Communicate and execute the risk minimization measures;

● Summarize drug safety profile for regulatory submission;

● Draft and review periodic safety report (e.g., DSUR, PSUR, and PBRER);

● Responsible for reviewing safety related actions during clinical trial and post marketing activities, including clinical trial protocol, IB, and CSRs;

● Keep undated on legislation within the pharmacovigilance area;

● External focus on communication with HA, partner and sponsor;

● Reply to questions and queries regarding safety issues;

● Provide drug safety training to internal staff or sponsor;

● Work with PV operation and data management teams to make timely decision regarding safety objectives;

QUALIFICATIONS

● Medical educational background with M.D. or PhD degree;

● Be proficient in working in English scenario;

● Good interpersonal communication skill;

● At least three years of practical clinical work experience, more than one year of CRO medical related work experience, global project experience is 

    preferred;

● Familiar with ICH guidelines, FDA, EMA regulations, understand GCP and other PV relevant regulation in China, FDA, and Europe;

RESPONSIBILITIES

● Produce the SDTM and ADaM datasets and tables, listings, and figures per programming specifications, Statistical Analysis Plans, and other study 

    relat Act as the lead programmer for the studies

● Independently ed documentation

● Create and validate case report data deliverables (SDTM dataset, Define.XML, SDRG, aCRF)

● Create and validate analysis dataset deliverables (ADaM datasets, Define.XML, ADRG)

● Able to generate regulatory submission-ready packages in an eCTD format including usage of Pinnacle 21

● Ensure SAS programs adhere to SOPs and guidance

● Develop SAS programs, standards macros to enhance the process

● Deliver products with high quality per agreed timelines

● Participate in the structure and content review of SDTM, SEND, ADaM datasets and maintain validation documentation

● Provide feedback on CRFs, Statistical Analysis Plans, and templates

● Provide input for the creation of database and analysis specifications

● Provide statistical programming for ad-hoc requests.

QUALIFICATIONS

● Bachelor's Degree in Statistics, Computer Science, Mathematics, or related discipline

● Four years' SAS programming experience in international pharmaceutical/biotech/CRO industry

● Experience in clinical drug development, regulatory requirements

● Proficient in SAS programming including SAS Base, SAS/STAT, SAS Macro, ODS, SAS/Graph

● Expert knowledge of CDISC SDTM and ADAM requirements for submission

● Proven ability to produce report quality tables graphs and data listings without direct supervision

● Demonstrated ability to support multiple difficult assignments with challenging timelines

● Solid problem-solving skills, attention to detail, good verbal and written English communication skills