Who Are We?

Founded in 1997 and built upon 20+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

What is the Primary Objective of the Clinical Research Associate (CRA)/ Sr. CRA?

You will manage clinical study sites to ensure subject safety and compliance with the study protocol, timeline and budget, in support of on time and within budget regulatory submissions.

‍To Succeed in this Position:

• You will be based in the Western part of the United States and near a major metropolitan area and airport hub.
• Ideally, you will have a Bachelor’s degree in a scientific discipline, RN or BSN degree, 4-year Life Science degree or equivalent and at least 3-5 years’ experience in clinical research or the medical field or a combination of education and experience that indicates the ability to perform the tasks associated with the position.
• Title of position (CRA vs. Sr. CRA) will be based on the selected candidate’s experience level.
• You must possess a knowledge/understanding of the principles of clinical research and drug development.
• You must have excellent written and oral communication skills, with the ability to manage multiple priorities.
• Attention to detail is critical for this role.
• You must be willing to travel 60-80%

**Would consider contract or permanent position

Your Main Responsibilities and Duties Include:

• You will assess of the suitability of clinical sites to conduct specific studies.
• You will initiate selected clinical study sites by providing training related to the protocol and management of the study.
• You will perform routine monitoring of clinical study sites to ensure subject safety and protocol compliance.
• You are responsible for the verification of data entered on the CRFs is consistent with clinical notes and other source documents.
• You will collect completed CRFs and queries from clinical sites.
• You will write monitoring visit reports and ensure the accountability of all test articles.
• You will close-out of clinical sites upon completion of the study.
• You will assist with study file audits and site audit preparation.
• You will develop and maintain routine contact with clinical study investigators and staff.
• You will assist with protocol, case report form and source document template development.
• You will ensure compliance with appropriate regulatory (GCP, FDA, ICH, HBP, etc.) and internal guidelines.
• You will assist with final report preparation.
• You will assist with internal SOP/guideline development.
• You will coordinate supplies forecasting and distribution and communicate across departments and conduct project team meetings concerning status of the study and specific sites.
• If Senior level, you will assist in the occasional mentoring and training of Clinical Research Associates on monitoring procedures and TI SOPs.

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We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. If you are smart and good at what you do, we welcome you to apply!

Who Are We?

Founded in 1997 and built upon 20+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego’s Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

What is the Primary Objective of the Clinical Project Manager?

You will provide project management and leadership to plan, prepare and execute high quality clinical trials. You will ensure that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.

To Succeed in this Position:

• You should have a Bachelor’s-level degree in science/health related field or a combination of education and industry experience. A Master’s degree is preferred.
• You should have 4 to 5 years of clinical research experience and/or at least 1 year of clinical project management specific experience, as well as a thorough understanding of GCPs and FDA and ICH guidelines. Job title will be determined based on experience level of the candidate of choice.
• You should have excellent written and oral communication skills with the ability to manage multiple priorities with high attention to detail.
• Remote-based will be considered for the right candidate; however, San-Diego based in preferred.
• Although travel is typically very limited, you must have the willingness to travel up to 15%

Your Main Responsibilities and Duties Include:

• You are responsible and accountable for multiple clinical trials and manage each project within defined timelines. You coordinate/execute of all operational aspects of clinical studies (including identification and management of vendors, availability of clinical supplies at the sites, review and approval of request for investigational test articles).
• You will facilitate investigational site budget negotiations.
• You will provide regular updates to TI staff, Sponsors, vendors and contract staff concerning status and progress of the trial.
• You will facilitate protocol development as needed.
• You are responsible for writing/approving clinical project deliverables such as scope definition documents, CRFs, source documents, monitoring tools, monitoring plans, close-out plans.
• You are responsible for ensuring the trial is “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). You ensure that any audit observations are addressed appropriately and in a timely manner.
• You are responsible for ensuring that project team members are compliant with TI SOPs and internal guidelines.
• You will assist with training and supervising CRAs.
• You will develop presentations, handouts and coordinate investigator meetings and make effective oral and written presentations.
• You will perform oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
• You are responsible for reviewing and approving all monitoring reports and correspondence with sites from CRAs.
• In regards to Data Management: You will perform SAP and DMP review, edit specifications review, and ensure query monitoring and resolution, review of data listings and clinical study report, as needed.

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We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

If you are smart and good at what you do, we welcome you to apply!

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PRIMARY OBJECTIVEOF THE POSITION:

The primary objective of the Biostatistician is to provide statistical expertise in the design and analysis of clinical studies, as well as the interpretation and reporting of the results.

EDUCATION AND EXPERIENCE:

The candidate should have a masters or doctoral level degree in statistics with at least 5-7 years of experience performing statistical analysis and reporting for clinical trials.

A thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines is essential. Excellent problem solving, organizational, written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical. Computer proficiency and SAS programming skills are required. Understanding of SDTM and ADaM standards. Ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.

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MAJOR RESPONSIBILITIES AND DUTIES:

Biostatistician responsibilities include, but are not limited to:

• Review of case report forms, annotated case report forms and database documentation to ensure that SAS datasets will be consistent with trial design
• Perform sample size calculations and write/review the statistical methodology section for clinical study protocols
• Generate study randomization plans and schedules
• Write statistical analysis plans (SAPs)
• Generate database listings for database QA audits
• Write SAS programs for statistical analyses, summary tables, figures and listings
• Perform statistical analyses of data and interpret results to ensure validity of conclusions
• Provide final tables, listings and figures for clinical study reports
• Interact with the medical writer in the production, review and approval of integrated clinical study reports
• Interact with members of the Clinical Development Team to ensure a high level of client satisfaction through the successful execution of projects
• Participate in Clinical Development Team meetings and also client meetings when needed
• Participate in departmental infrastructure building; experience developing and implementing programing standards/best practices, developing and maintaining SAS macro and program libraries, and managing/forecasting workload with the ability to prioritize work to support multiple trials

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Who Are We?

Founded in 1997 and built upon 20+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego's Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients.

Who Are You?

You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently.

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What is the Primary Objective of the CDISC SAS Programmer?

You will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies and have extensive knowledge of CDISC SDTM and ADaM data structures.

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To Succeed in this Position:

• You should have Bachelor's degree in Statistics, Mathematics, or Computer Science or in a related field.
• You should have a minimum of 4 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
• You have a knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
• You should be able to demonstrate extensive knowledge of SDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
• You have excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• You have great verbal/written communication and interpersonal skills to effectively interface with others.
• You have the ability to think strategically in order to improve current processes.
• You have the ability to work independently and prioritize with minimal daily instruction.
• If you have NDA submission experience that is a plus.

***San Diego-based not required but highly preferred.

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Your Main Responsibilities and Duties Include:

• Generating analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications.
• Performing quality control for SAS programs and other study documents (e.g., presentations and reports).
• Generating SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files.
• Maintaining complete and auditable documentation of all programming activities.
• Reviewing output across SAS programs to ensure consistency.
• Providing statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
• Supporting our Clinical Data Managers with data review via SAS programmed data checks and listings.
• Assisting in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
• Participating in the development and/or maintenance of departmental procedures and standards.
• Reviewing CRFs, edit check specifications, and table mock-ups.
• Working collaboratively with cross functional groups, study team, and vendors.
• May assist in creation of table, figure, or listing mockups under supervision of statisticians.

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