This is a part-time consulting role for 20hr/week. Duration of the project will be approximately 3-4 months. Preference will go to candidates in the Boston area. 

Your impact:

As the AI Adoption Consultant, you will bridge the gap between cutting-edge artificial intelligence and the complex workflows of a modern biotechnology organization. Your mission is to accelerate the integration of AI tools across the enterprise, moving beyond the "hype" to deliver tangible improvements in operational efficiency and scientific output.

You will partner with leaders in Research, Clinical Operations, Finance, IT, and People & Culture to identify high-impact opportunities, design implementation roadmaps, and lead a culture-shifting training program to ensure every employee is "AI-fluent."

Your day-to-day:  

• Conduct deep-dive discovery sessions with functional leads (Finance, IT, Research, etc.) to map existing workflows and identify bottlenecks.
• Build a prioritized "AI Opportunity Roadmap" that balances quick wins with long-term strategic shifts.
• Evaluate and recommend third-party AI tools or internal LLM applications that meet the specific security and compliance standards of the biotech industry.
• Collaborate with the CIO and IT team to ensure AI deployments are scalable, secure, and integrated into the existing tech stack.
• Develop and deliver tailored training modules for diverse audiences—from "AI for Scientists" to "Prompt Engineering for Finance Professionals."
• Create "Office Hours" and internal communities of practice to foster continuous learning and peer-to-peer knowledge sharing.
• Work with Legal and IT to establish clear guidelines for the ethical use of AI, particularly regarding sensitive data and intellectual property.

Must-Haves:

• Experience: 5+ years of experience in digital transformation, management consulting, or a similar role, with at least 1-2 years focused specifically on AI/ML implementation.
• Industry Knowledge: Direct experience in the Biotech or Pharmaceutical sector is highly preferred.
• Technical Fluency: A strong understanding of Large Language Models (LLMs), Generative AI tools, and data orchestration. You don't need to be a coder, but you must be able to speak the language of both data scientists and end-users.
• Communication: Exceptional ability to translate complex technical concepts into "business value" for non-technical stakeholders.
• Education: Bachelor’s degree in a relevant field (CS, Data Science, Business, or Life Sciences).

Your impact:

As a Senior Clinical Trial Associate, you’ll be a key player in keeping our clinical studies on track—managing the details, supporting the team, and helping bring innovative treatments to patients

Your day-to-day:  

• Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF's, monitoring visit reports, etc.
• Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs
• Perform quality checks on the study TMF with oversight of study COL
• Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc. May coordinate and track clinical trial equipment and supplies
• Review and track vendor invoices against contracts with oversight of study COL
• Coordinates and tracks administrative aspects of contract execution and PO generation
• Supports the trial team to produce and distribute study newsletters
• Supports collection and updating of clinical trial insurance
• Supports posting of all agreed clinical trials to publicly available websites
• Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc.
• May support additional ad-hoc activities as agreed with the study COL

Must-Haves:

• Bachelor's degree in life sciences or healthcare related field
• 3+ years' experience in a clinical trial support position, experience in Biotech or Pharma strongly preferred
• Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
• Solid understanding of the responsibilities and needs of other functions in a clinical trial
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Ability to multitask and flex across projects as priorities and deadlines shift
• Ability to maintain confidentiality of proprietary information
• A team player that takes initiative and is proactive 

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $90,000-$110,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

This role is onsite in our Boston office. We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

This role is based in Boston, MA with onsite presence required Monday-Wednesday

Your impact:

In this role, you’ll work with our Clinical Operations Leads to help keep trials running smoothly across multiple indications. It’s a hands-on, high-impact role on a fun, driven team where you’ll grow fast and make a real difference. 

Your day-to-day:  

• Provide support to the Clinical Operations Lead (COL) in the planning, execution, and oversight of a global phase 3 clinical trial from study start-up to close-out.
• Support the development, review and tracking of study-related documents (protocols, ICFs, investigative brochure, monitoring visit reports, etc.) with cross functional team collaboration.
• Support start-up activities to help accelerate country and site activations.
• Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
• Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.
• Maintain and organize trial documentation (e.g., TMF/eTMF oversight, trackers, meeting minutes) ensuring that study documentation is in a continuous state of inspection readiness.   
• Contribute to inspection readiness activities and ensure compliance with GCP and SOPs.
• Help identify and resolve site risks and/or issues to foster positive site relationships.
• Coordinate internal team meetings and participate in cross-functional study meetings.
• Proactively communicate study updates with key internal and external stakeholders.

Must-Haves:

• Bachelor’s degree preferably in life sciences or healthcare related field.
• 5+ years of clinical operations experience within the biotech or pharma industry required
  • Title and level commensurate with experience  
• Experience managing outsourced global clinical trials across Phase I–III.
• Prior involvement in study start-up activities strongly preferred
• Solid understanding of GCP, ICH guidelines, and the clinical development process.
• Experience with clinical trial management systems (CTMS), eTMF, and other operational tools.
• Ability to multitask and flex across projects as priorities and deadlines shift.
• Highly organized with excellent communication and interpersonal skills.
• Strong attention to detail and ability to multitask in a dynamic, fast-paced setting.
• A collaborative team player that takes initiative.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for the Associate Clinical Trial Manager is $115,000-$135,000 and for Clinical Trial Manager it is $140,000-160,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday-Wednesday to create more opportunities for innovation, collaboration, and connection.

Your impact:

High visibility role as DSPV Operations Lead, will play a critical, strategic and hands-on operational role in supporting PV across all clinical development programs.  

Your day-to-day:  

Clinical Trial Support

• Lead the process for Individual Case Safety Report (ICSR) collection, processing, reconciliation, submission and distribution ensuing compliance with regulatory timelines and global regulations and guidelines
• Oversee reconciliation activities between the safety and clinical databases, as well as business partner safety data exchange
• Identify and support the development of Safety Management Plans (SMPs), and other study specific project plans
• Work closely with Data Management of EDC development for the purposes of safety data collection including Annotated CRF reviews and associated activities.
• Collaborate with DSPV Safety Science and Data Management to prepare safety data listings and reports as needed and to participate in QC related to safety data for various reports and deliverables
• Collaborate cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Development, Data Management, Quality Assurance, and other relevant teams to ensure appropriate PV processes are in place and adhered to
• Prepare and deliver training on SAE reporting processes and practices at Investigator Meetings, to CRAs, to CROs, sites, as applicable.
• Lead DSPV Trial Master File document review, QC and provision to study specific TMFs
• Support DSUR preparation by maintaining DLP and submission calendar, supporting Kick-Off Meeting activities, requests for and attainment of information from cross-functional teams
• Assist with DSPV Operational processes and initiatives, representing PV Operations in collaboration with other functions as needed.

Vendor Management

• Lead day-to-day operational oversight of pharmacovigilance service provider
• Establish and/or maintain oversight of key performance indicators (KPIs), key risk indicators (KRIs), key quality indicators (KQIs), and routine operational reports
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of PSPV quality activities, and functional goals
• Obtain close oversight of ICSR quality including performance of QC as needed
• Oversee safety database configuration updates, system updates, maintenance, E2B gateway implementations, user account management, back-up testing, and other activities as required
• Support and oversee deviation and Corrective and Preventive Action (CAPA) activities related to, but not limited to, expedited and periodic reporting activities, deviations related to case management processes, as defined in the SMPs or SOPs, and PVA compliance

Quality and Compliance

• Support the development, review, and maintenance of Standard Operating Procedures (SOPs) / Work Instructions (WIs) for DSPV.
• Support PV audit and inspection activities, as required, and serve as SME for DSPV Operations during these activities
• Ensure DSPV processes and systems comply with global regulatory guidelines, company policies, industry best practices, and PVAs.
• Maintain a comprehensive DSPV Quality Management System aligned with DSPV functional goals
• Prepare and present DSPV Compliance Reports to DSPV/QA forum, highlighting trends, issues, and opportunities for improvement

Must-Haves:

• Degree in Life Sciences, Pharmacy, Nursing or related field
• 8+ years of experience in PV in Biotech, Pharma, or a CRO
• 5 years of experience working with and providing oversight to PV vendors and/or hosting partners.
• Experience in preparation and review of data outputs for aggregate safety report generation (i.e., DSUR, PBRER).
• Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance.
• Effective collaboration and interpersonal skills.
• Ability to work independently, establish work priorities, and execute decisions with minimal guidance
• Excellent decision-making and analytical skills.

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $170,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Your Impact:

Rapport is seeking an Associate Director / Director of Biostatistics who will have a hands-on role in shaping the design, analysis, and interpretation of clinical trial data for our precision neuromedicine programs. Reporting to the Head of Biostatistics, you will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process.

Your Day-to-Day:

• Working as a leading statistician on multiple studies/projects. Oversee the production of protocol development (study design, endpoint selection, sample size calculation and statistical methods) and Statistical Analysis Plan (SAP) that lead to comprehensive clinical study reports suitable for regulatory submissions.
• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans
• Support statistical programming to plan, execute and deliver SDTM and ADaM datasets, tables, listings, and figures (TLFs). Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
• Provide statistical input and the interpretation of results to clinical study reports, regulatory submissions documents, and publications, in collaboration with the clinical, regulatory, and medical affairs teams.
• Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards.
• Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
• Oversee and manager external CROs and vendors to ensure high-quality and timely deliverables.
• Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making.

Must-Haves:

• Associate Director: PhD with 6+ years or MS with 9+ years of biostatistics experience
  • Director: PhD with 9+ years or MS with 12+ years of biostatistics experience
• CNS therapeutic area experience is a plus
• Skilled in scientific programming including SAS or R, or Python for data analysis, graphing, and simulation
• Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH)
• Extensive knowledge with CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting
• Ability to communicate complex statistical concepts clearly to non-statistical audiences.
• Ability to manage multiple projects in a fast-paced environment, flexibility to adapt to changing priorities and timelines
• Ability to effectively collaborate with internal stakeholders and manage the statistical work of external stakeholders/vendors

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $190,000-$220,000 for the Associate Director level and $230,000-$250,000 for the Director level. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

This role has the ability to be fully remote. If you are located in the Boston area, we prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Your Impact:

The Director of Regulatory Strategy will play a pivotal role in leading strategic regulatory initiatives for assigned drug development programs.

Your Day-to-Day:

• Create and implement innovative and effective regulatory strategies to support the development of Rapport global drug development programs
• Provide regulatory expertise and advise to cross-functional team members including clinical, CMC, clinical pharmacology, and nonclinical
• Accountable for the maintenance of regulatory applications such as INDs, CTAs, NDAs, etc.
• Identify regulatory risks and mitigation plans
• Serve as the regulatory lead on project teams
• Ensure compliance with local and international submission requirements, manage CROs as applicable.
• Represents Rapport as the point of contact for regulatory health authorities, as assigned ensuring exemplary ethics and transparency within the company and with health authorities
• Keeps current with global regulatory landscape and advises project teams on potential impact to programs
• Provide mentorship and support to junior team members to foster their professional growth and development

Must-Haves:

• Bachelors degree in a life science or related discipline
• 12+ years of experience in the pharmaceutical or biotech industry
• Experience in neurology and small molecules preferred
• Global drug development experience
• Experience working with DAAP or Neurology FDA Divisions
• Ability to manage competing priorities, influence and integrate within a team, manage timelines and deliver on corporate and program goals.
• Strong interpersonal skills and alignment with Rapport’s values and company culture
• Must demonstrate strong leadership and team building skills, including experience with conflict resolution and real time problem solving.
• Thorough understanding of the development phases within a fast-moving biopharmaceutical organization.
• Exceptional written and verbal communication skills

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $220,000 to $240,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.