Who Are We?

Founded in 1997 and built upon 26+ 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 2-3 years of clinical project management specific experience at a CRO, 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 here: https://therapeuticsinc.bamboohr.com/careers/39?source=aWQ9MjU%3D

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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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