Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.

Summary 

In this newly created role, the Scientific Director, Medical Information & Medical Communications will serve as a senior individual contributor within Medical Affairs, responsible for owning the medical information foundation and scientific narrative across Tango’s pipeline.

This role will be central to ensuring Tango is prepared to support increasing external engagement, regulatory interactions, congress presence, publications, and future commercialization. This is an exciting opportunity to shape foundational capability during a period of significant clinical and organizational inflection.

Your Role

     Medical Information Strategy & Operations

• Lead the end-to-end medical information strategy, including oversight of external MI vendors and call center operations
• Ensure timely, accurate, compliant, and evidence-based responses to external inquiries
• Develop, maintain, and govern medical information content, including SRLs, CRLs, FAQs, and response guidance
• Own medical information SOPs, KPIs, quality metrics, audit readiness, and inspection preparedness
• Ensure alignment with pharmacovigilance, regulatory, and compliance requirements

      Scientific Narrative & Medical Communications

• Develop and maintain Tango’s core scientific platform and data narrative across indications and development stages
• Translate complex clinical, nonclinical, and mechanistic data into clear and compelling content for internal and external audiences
• Ensure consistency of scientific messaging across medical information, field materials, congress assets, and internal communications

      Publications, Congress, & Content Governance

• Partner with Medical Affairs and Clinical teams to support publication planning and execution
• Oversee development of scientific materials for major medical congresses
• Provide medical information support at congresses, as appropriate
• Participate in the Medical Review process to ensure scientific accuracy, compliance, and data integrity

      Cross-Functional Collaboration

• Collaborate closely with Medical Affairs leadership, Clinical Development, Regulatory Affairs, Corporate Communications, and Commercial (as appropriate and compliant)
• Ensure alignment between scientific communications, medical strategy, and enterprise objectives
• Perform additional duties as required to support Medical Affairs goals

What You Bring 

• Advanced scientific degree required (PharmD, PhD, or MD strongly preferred)
• 7–10+ years of experience in Medical Affairs, Medical Information, or Scientific/Medical Communications
• Oncology experience strongly preferred; experience in GI malignancies, NSCLC, or precision oncology highly valued
• Experience in clinical-stage and/or pre-commercial biotech environments
• Exceptional scientific writing, editing, and data-positioning skills
• Strong understanding of clinical development, regulatory pathways, and medical affairs operations
• Demonstrated ability to manage vendors, agencies, and cross-functional stakeholders
• Experience with Veeva MedComms and PromoMats preferred
• Ability to operate effectively through ambiguity in a resource-constrained environment
• Excellent written and oral communication skills

Work Environment

• This role may be remote, with periodic travel to Tango offices and scientific meetings
• Approximately 10–20% travel

#LI-Remote

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Sr. Medical Director/Executive Director, Early Clinical Development as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Sr. Medical Director/Executive Director of Early Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects. The candidate for this role will be responsible to lead the Early Clinical Development Team, for IND submission and the design, execution and oversight of first-in-human, dose finding clinical trials. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, etc.) and the relevant compliance framework for clinical development activities are essential. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

• Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) stage clinical trials.
• Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy.
• Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for business development and partnership activities as needed.
• Act as a champion for high standards of compliance, ethics and safety, and putting patients first.

Requirements

• MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology.
• 3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech - preferred but not required.
• Demonstrated capacity to think creatively when addressing complex situations
• Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs.
• Experience leading pre-IND and IND meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
• Able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project management including peer to peer interactions with academic scientific experts, KOLs and stake holders.
• Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the team work
• Ensures compliance with corporate policies and procedures, as well as, all related healthcare laws and regulations
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies
• Strong track record of delivering results through effective team and peer leadership in matrix
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into clinical development strategies.
• Travel requirement up to 15-20 % of the time.

The advertised pay range covers both levels of this position.

Here's the base pay range by level:

Sr. Medical Director, Early Clinical Development- $294,483 - $386,511

Executive Medical Director, Early Clinical Development- $338,656- $444,486

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

#Li-AS1

#Li-Hybrid

The Enterprise Account Executive (Healthcare & Life Sciences) will report to the Director of Enterprise GTM and own revenue growth across a portfolio of Scale AI’s most strategic healthcare and life sciences customers. This role is focused on selling complex, agentic AI solutions - autonomous workflows powered by LLMs and human-in-the-loop systems - into health systems, payers, pharma, biotech, and digital health organizations.

You will act as a strategic partner to clinical, operational, and technical leaders - helping them transform core workflows such as clinical documentation, prior authorization, revenue cycle, pharmacovigilance, clinical trials, medical affairs, and patient engagement through AI agents. This is a highly consultative, technical enterprise sales role requiring deep domain fluency, strong executive presence, and the ability to navigate regulatory, compliance, and multi-stakeholder complexity.

You will own the full customer lifecycle - from origination through close, deployment, and expansion - while quarterbacking cross-functional teams across Solutions Engineering, Product, Research, and Delivery to land and scale high-impact AI programs.

You Will:

• Own and expand relationships with leading healthcare and life sciences organizations (providers, payers, pharma, biotech), focusing on multi-year, strategic AI initiatives
• Sell agentic AI solutions by mapping Scale’s capabilities to high-impact workflows (e.g., clinical documentation, prior auth, revenue cycle, patient ops, clinical trials, drug safety, medical review)
• Build trusted relationships with executive stakeholders (CIO, CTO, CMIO, Chief Data/AI Officer, Heads of Clinical Ops, R&D, Commercial)
• Develop and execute multi-threaded account strategies that drive net-new revenue, expansion, and long-term platform adoption
• Lead complex deal cycles, including ROI modeling, business case development, and mutual close plans across new business, renewals, and expansions
• Partner closely with Solutions Engineering to design and land technically credible pilots, POVs, and production deployments
• Navigate healthcare-specific regulatory and compliance requirements (e.g., HIPAA, GxP, data governance, auditability) throughout the sales process
• Act as the voice of the customer internally - informing product roadmap, agent design, and vertical-specific solutions
• Maintain strong pipeline discipline, forecasting accuracy, and deal hygiene using Salesforce, Clari, and related tools
• Operate effectively in a fast-paced, cross-functional environment with high ownership and attention to detail

Ideally, You Will Have:

• 8–12+ years of enterprise sales experience, with significant focus on healthcare or life sciences (providers, payers, pharma, biotech, or digital health)
• Proven track record of closing and expanding large, complex, multi-million dollar deals in regulated environments
• Experience selling AI/ML, data platforms, or workflow automation technologies, with the ability to position agentic / LLM-driven solutions to both technical and non-technical stakeholders
• Strong understanding of key healthcare/life sciences workflows (e.g., clinical operations, revenue cycle, patient engagement, R&D, clinical trials, pharmacovigilance)
• Demonstrated success engaging executive stakeholders and building compelling ROI-driven business cases
• Familiarity with regulatory and compliance considerations (e.g., HIPAA, FDA/GxP, data privacy, model governance)
• Strong command of enterprise sales fundamentals, including account planning, multi-threading, and forecasting discipline
• Ability to navigate long, complex sales cycles with multiple stakeholders and competing priorities
• Excellent communication, storytelling, and executive presence
• High degree of ownership, intellectual curiosity, and a consultative, customer-first mindset

Nice to Haves:

• Experience selling agentic AI, LLM platforms, or automation solutions into healthcare or life sciences
• Background working with clinical, regulatory, or data organizations
• Familiarity with EHR systems, clinical data, or real-world evidence platforms
• Experience in high-growth or emerging technology environments

Title:                    Project Manager

Job Type:            Full-time

Tenure:               Permanent

Location:            London, UK

Education:         Bachelor’s degree (or equivalent)

We invite you to come grow with us.

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health.

Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward. 

About the team:

The RP Operations team works alongside our Custom and Syndicated research teams to deliver a broad range of qualitative and quantitative (ad hoc and tracking) studies for global pharmaceutical, MedTech and biotech clients to enable them to address product development, marketing, brand, advertising and communications objectives. Our studies are typically multi-market, encompassing respondents in Europe, North America and Emerging Markets.

Each of our research projects will have a dedicated member of the RP Operations team embedded within the core project team for the full project lifecycle, providing project management expertise and guidance throughout. Typically, members of our Operations team will support multiple projects concurrently.

Within the Operations department, members of the team are encouraged to support subject-matter Pillars, led by Project Directors and Associate Project Directors. These Pillars include initiatives and programmes focusing on Clients, Suppliers, People, Innovation, and Operational Excellence. As a Project Manager, you are empowered to take on ownership of a sub-topic within your Pillar and can have responsibility for developing ideas and initiatives relevant to that sub-topic.

Within this role you will be empowered to develop your project management expertise across the healthcare market research landscape, and will have the opportunity to work with a wide range of different experts in our teams.

Your primary role:

The role of the Project Manager is to cost and oversee the set up and management of fieldwork and data collection to ensure successful completion within best practices. You will also be expected to contribute to company operations processes; providing proactive ideas and plans about improving the efficiency of the project management function and projects. Core, but not exclusive, responsibilities will include:

• Responsibility for sourcing, obtaining and negotiating commercially advantageous costs from external suppliers and panel providers for Research Partnership project proposals
• Updating suppliers on the status of their quotes
• Overseeing the smooth running of fieldwork management
• Successful handover of project deliverables to research team:
  • Coordination of Data Processing (DP) work and deliverables, based on specs and templates provided by the project team (Quant-only)
  • Coordination of Qual deliverables, including: Transcripts and/or recordings (notes, videos, audio files) (Qual-only)
• Own, coordinate and update project timelines with internal research and external client and supplier stakeholders
• Take ownership for coordinating project team meetings,
• Opportunity to develop line management responsibilities for junior members of the team
• Responsibility for Pharmacovigilance and Adverse Event reporting
• Coordination of client and supplier Statements of Work (SOWs)
• Client and supplier invoice management (PO numbers, invoicing and liaison with Finance team)
• You will own specific sub-topics as a member of one of the department’s Pillars (Clients, Suppliers, People, Innovation, Operational Excellence)

About You…

Your skills and experience:

• More than 3 years of experience in market research project management (qualitative and/or quantitative research)
• Experience managing healthcare market research projects
• Knowledge of the fieldwork agency landscape
• Strong project management skills (adhering to agreed timelines, troubleshooting and communication with internal and external stakeholders)
• Ability to multitask
• Collaboration and working as part of a team
• Ability to work under pressure and to tight deadlines
• Excellent numerical skills

Ideal profile:

• You are proactive, dedicated and enthusiastic, with a ‘can do’ attitude and approach
• You demonstrate a high level of accuracy and attention to detail, as well as strengths in organisation and prioritisation
• You are a collaborative team player who works well with colleagues
• You communicate ideas and issues in an effective, straightforward fashion
• You are highly motivated and want to seize opportunities to develop new skills and progress your career

Life at Research Partnership:

We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide:

• A comprehensive training and development programme for all staff, from entry level apprentice to senior management
• A relaxed and friendly working environment
• Social events - including a summer day out and end-of-year party, along with regular social events after office hours
• Fundraising and charity events – we support Forever Angels, a children's charity whose aim is to care for abandoned babies in Tanzania, Africa, as well as the local charity, Fulham Good Neighbours

Further information:

This is a full-time role, working in a hybrid pattern (2 days per week in the office) at our fantastic HQ location in Fulham Green, directly opposite Putney Bridge in London, which boasts free state-of-the-art gym with showers, on-site café, panoramic river views, landscaped gardens and regular social events.

Title:                    Project Manager

Job Type:            Full-time

Tenure:               Permanent

Location:            London, UK

Education:         Bachelor’s degree (or equivalent)

We invite you to come grow with us.

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health.

Our Research Partnership healthcare market research team provides research and insights to inform and power healthcare decisions. Serving a variety of clients across the lifecycle, our expertise includes data, research & insights (proprietary syndicated and custom research) and brand tracking (ATU). Proudly part of Inizio – the market-leading commercialization partner for health and life sciences. From early-stage development to loss of exclusivity, we simplify complexity, unlock value, and make collaboration seamless at every pivotal moment – supporting confident, insight-driven decisions that move innovation forward. 

About the team:

The RP Operations team works alongside our Custom and Syndicated research teams to deliver a broad range of qualitative and quantitative (ad hoc and tracking) studies for global pharmaceutical, MedTech and biotech clients to enable them to address product development, marketing, brand, advertising and communications objectives. Our studies are typically multi-market, encompassing respondents in Europe, North America and Emerging Markets.

Each of our research projects will have a dedicated member of the RP Operations team embedded within the core project team for the full project lifecycle, providing project management expertise and guidance throughout. Typically, members of our Operations team will support multiple projects concurrently.

Within the Operations department, members of the team are encouraged to support subject-matter Pillars, led by Project Directors and Associate Project Directors. These Pillars include initiatives and programmes focusing on Clients, Suppliers, People, Innovation, and Operational Excellence. As a Project Manager, you are empowered to take on ownership of a sub-topic within your Pillar and can have responsibility for developing ideas and initiatives relevant to that sub-topic.

Within this role you will be empowered to develop your project management expertise across the healthcare market research landscape, and will have the opportunity to work with a wide range of different experts in our teams.

Your primary role:

The role of the Project Manager is to cost and oversee the set up and management of fieldwork and data collection to ensure successful completion within best practices. You will also be expected to contribute to company operations processes; providing proactive ideas and plans about improving the efficiency of the project management function and projects. Core, but not exclusive, responsibilities will include:

• Responsibility for sourcing, obtaining and negotiating commercially advantageous costs from external suppliers and panel providers for Research Partnership project proposals
• Updating suppliers on the status of their quotes
• Overseeing the smooth running of fieldwork management
• Successful handover of project deliverables to research team:
  • Coordination of Data Processing (DP) work and deliverables, based on specs and templates provided by the project team (Quant-only)
  • Coordination of Qual deliverables, including: Transcripts and/or recordings (notes, videos, audio files) (Qual-only)
• Own, coordinate and update project timelines with internal research and external client and supplier stakeholders
• Take ownership for coordinating project team meetings,
• Opportunity to develop line management responsibilities for junior members of the team
• Responsibility for Pharmacovigilance and Adverse Event reporting
• Coordination of client and supplier Statements of Work (SOWs)
• Client and supplier invoice management (PO numbers, invoicing and liaison with Finance team)
• You will own specific sub-topics as a member of one of the department’s Pillars (Clients, Suppliers, People, Innovation, Operational Excellence)

About You…

Your skills and experience:

• More than 3 years of experience in market research project management (qualitative and/or quantitative research)
• Experience managing healthcare market research projects
• Knowledge of the fieldwork agency landscape
• Strong project management skills (adhering to agreed timelines, troubleshooting and communication with internal and external stakeholders)
• Ability to multitask
• Collaboration and working as part of a team
• Ability to work under pressure and to tight deadlines
• Excellent numerical skills

Ideal profile:

• You are proactive, dedicated and enthusiastic, with a ‘can do’ attitude and approach
• You demonstrate a high level of accuracy and attention to detail, as well as strengths in organisation and prioritisation
• You are a collaborative team player who works well with colleagues
• You communicate ideas and issues in an effective, straightforward fashion
• You are highly motivated and want to seize opportunities to develop new skills and progress your career

Life at Research Partnership:

We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide:

• A comprehensive training and development programme for all staff, from entry level apprentice to senior management
• A relaxed and friendly working environment
• Social events - including a summer day out and end-of-year party, along with regular social events after office hours
• Fundraising and charity events – we support Forever Angels, a children's charity whose aim is to care for abandoned babies in Tanzania, Africa, as well as the local charity, Fulham Good Neighbours

Further information:

This is a full-time role, working in a hybrid pattern (2 days per week in the office) at our fantastic HQ location in Fulham Green, directly opposite Putney Bridge in London, which boasts free state-of-the-art gym with showers, on-site café, panoramic river views, landscaped gardens and regular social events.

About us:

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health.

Research Partnership (part of Inizio Ignite) is one of the world's largest pharma market research and consulting agencies with over 250 researchers, consultants, project managers and support staff. Our teams are located across the globe, in Europe (London, Lyon), North America (New York, Philadelphia, San Francisco) and Asia (Singapore, Delhi).

About the team:

The RP Operations team works alongside our Custom and Syndicated research teams to deliver a broad range of qualitative and quantitative (ad hoc and tracking) studies for global pharmaceutical, MedTech and biotech clients to enable them to address product development, marketing, brand, advertising and communications objectives. Our studies are typically multi-market, encompassing respondents in Europe, North America and Emerging Markets.

Each of our research projects will have a dedicated member of the RP Operations team embedded within the core project team for the full project lifecycle, providing project management expertise and guidance throughout. Typically, members of our Operations team will support multiple projects concurrently. As an Insights Field Operations Associate Director, this will involve working directly with both the Research Directors, as well as with other departments (Finance, IT, Creative) to provide Project Management subject matter expertise.

As a Field Operations Associate Director you will have responsibility for managing a team of Project Managers/Executives. This will involve mentoring, performance management as well as overseeing recruitment activities (interviewing candidates) for roles within your team. You will also be responsible for delivering subject-specific training both within your line management team and the wider Operations team.

Your primary role:

The Field Operations Associate Director is a senior leadership role within US Field Operations at Insights. The role is responsible for overseeing the quality, consistency, and delivery of project management output from a team of RP Project Managers, while also acting as a hands-on Project Manager on active studies.

This position plays a central role in supporting the alignment of project management roles and responsibilities across RP and STEM within Insights. Working closely with the Head of US Field Operations, the Associate Director will develop a deep understanding of both RP and STEM operating models and contribute to the evolution of project management capabilities under the Insights organization.

The role combines direct project delivery, people leadership, client engagement, and cross-business collaboration, and requires strong judgement, operational credibility, and the ability to lead through complexity.

Key Responsibilities

Project Delivery & Oversight

• Oversee the end-to-end delivery and quality of US RP project management output, ensuring projects are delivered to a high standard and in line with client expectations.
• Act as Project Manager on assigned studies, maintaining full responsibility for operational execution from project set-up through to delivery.
• Hold full project-level decision-making authority, including management of scope, timelines, and delivery risks.
• Escalate resourcing constraints or significant capacity challenges to the Head of US Field Operations as required.
• Serve as a senior escalation point for complex delivery issues and client concerns.

Hands-on Project Management Responsibilities

• Oversee the smooth running of fieldwork management, coordinating with internal teams and external suppliers.
• Ensure the successful handover of project deliverables to research teams, including:
• Coordination of Data Processing (DP) work and deliverables for quantitative projects, in line with provided specifications and templates.
• Coordination of qualitative deliverables, including transcripts and/or recordings (notes, video, and audio files), as required.
• Own, coordinate, and maintain project timelines, working closely with internal research teams, clients, and suppliers.
• Take ownership of coordinating project team meetings, including scheduling and facilitation.
• Hold responsibility for Pharmacovigilance and Adverse Event reporting, ensuring compliance with internal and regulatory standards.
• Coordinate client and supplier Statements of Work (SOWs).
• Manage client and supplier invoicing, including PO number tracking, invoice coordination, and liaison with the Finance team.

Team Leadership & Line Management

• Line manage a team of RP Project Managers and Senior Project Managers.
• Provide coaching, feedback, and development support to strengthen project management capability and consistency of output.
• Support professional development and performance management of RP PMs.

Client Engagement

• Engage directly with clients on escalations, delivery challenges, and complex projects.
• Act as a senior point of contact for project delivery matters when required.
• Partner with internal stakeholders to support strong, long-term client relationships.

RP & STEM Alignment within Insights

• Work closely with the Head of US Field Operations to build a strong understanding of RP and STEM as distinct businesses.
• Support the alignment and clarification of project management roles and responsibilities across RP and STEM within Insights.
• Contribute to discussions on how project management capabilities and expectations can be enhanced and aligned over time, while recognizing existing team processes.
• Act as a bridge between RP project management and the wider Insights Field Operations organization.

Global Collaboration

• Collaborate with Associate Project Directors in the UK and APAC to support alignment of RP project management approaches globally.
• Share best practices and support consistent quality of project output across geographies.
• Contribute to global discussions on project management standards and ways of working for RP within Insights.

About You…

Your skills and experience:

• More than 7 years of experience in market research project management (qualitative and/or quantitative research)
• Experience managing healthcare market research projects
• Significant experience with team management (including line management and training of a team of junior Project Managers)
• Established relationships with fieldwork agency suppliers
• Strong project management skills (adhering to agreed timelines, troubleshooting and communication with internal and external stakeholders)
• Proven ability to manage complex, multi-stakeholder projects and make independent delivery decisions.
• Experience handling client escalations and operating confidently in senior client environments.
• Comfortable working across teams and geographies and contributing to organizational alignment efforts.
• Highly organized, detail-oriented, and able to balance delivery with people leadership.

Ideal profile:

• You are proactive, dedicated and enthusiastic, with a ‘can do’ attitude and approach
• You demonstrate commercial and analytical capabilities
• You demonstrate a high level of accuracy and attention to detail, as well as strengths in organization and prioritization
• You demonstrate a track record of identifying operational efficiencies
• You are a collaborative team player who works well with colleagues
• You communicate ideas and issues in an effective, straightforward fashion
• You are highly motivated and want to seize opportunities to develop new skills and progress your career

Life at Research Partnership:

We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide:

• A comprehensive training and development program for all staff, from entry level apprentice to senior management
• A relaxed and friendly working environment
• Social events - including a summer day out and end-of-year party, along with regular social events after office hours

#LI-ND1

#LI-Remote

About us:

Inizio Ignite is the global advisory partner for health and life sciences, encompassing connected expertise across Research Partnership, Putnam, Vynamic, and STEM. Guided by purpose, passion, and precision, we collaborate with clients to ignite impact, accelerate performance, and deliver lasting change for patients. By uniting strategy, insights, and innovation with a unique depth and breadth of expertise, we drive transformation and shape the future of health.

Research Partnership (part of Inizio Ignite) is one of the world's largest pharma market research and consulting agencies with over 250 researchers, consultants, project managers and support staff. Our teams are located across the globe, in Europe (London, Lyon), North America (New York, Philadelphia, San Francisco) and Asia (Singapore, Delhi).

About the team:

The RP Operations team works alongside our Custom and Syndicated research teams to deliver a broad range of qualitative and quantitative (ad hoc and tracking) studies for global pharmaceutical, MedTech and biotech clients to enable them to address product development, marketing, brand, advertising and communications objectives. Our studies are typically multi-market, encompassing respondents in Europe, North America and Emerging Markets.

Each of our research projects will have a dedicated member of the RP Operations team embedded within the core project team for the full project lifecycle, providing project management expertise and guidance throughout. Typically, members of our Operations team will support multiple projects concurrently. As an Insights Field Operations Associate Director, this will involve working directly with both the Research Directors, as well as with other departments (Finance, IT, Creative) to provide Project Management subject matter expertise.

As a Field Operations Associate Director you will have responsibility for managing a team of Project Managers/Executives. This will involve mentoring, performance management as well as overseeing recruitment activities (interviewing candidates) for roles within your team. You will also be responsible for delivering subject-specific training both within your line management team and the wider Operations team.

Your primary role:

The Field Operations Associate Director is a senior leadership role within US Field Operations at Insights. The role is responsible for overseeing the quality, consistency, and delivery of project management output from a team of RP Project Managers, while also acting as a hands-on Project Manager on active studies.

This position plays a central role in supporting the alignment of project management roles and responsibilities across RP and STEM within Insights. Working closely with the Head of US Field Operations, the Associate Director will develop a deep understanding of both RP and STEM operating models and contribute to the evolution of project management capabilities under the Insights organization.

The role combines direct project delivery, people leadership, client engagement, and cross-business collaboration, and requires strong judgement, operational credibility, and the ability to lead through complexity.

Key Responsibilities

Project Delivery & Oversight

• Oversee the end-to-end delivery and quality of US RP project management output, ensuring projects are delivered to a high standard and in line with client expectations.
• Act as Project Manager on assigned studies, maintaining full responsibility for operational execution from project set-up through to delivery.
• Hold full project-level decision-making authority, including management of scope, timelines, and delivery risks.
• Escalate resourcing constraints or significant capacity challenges to the Head of US Field Operations as required.
• Serve as a senior escalation point for complex delivery issues and client concerns.

Hands-on Project Management Responsibilities

• Oversee the smooth running of fieldwork management, coordinating with internal teams and external suppliers.
• Ensure the successful handover of project deliverables to research teams, including:
• Coordination of Data Processing (DP) work and deliverables for quantitative projects, in line with provided specifications and templates.
• Coordination of qualitative deliverables, including transcripts and/or recordings (notes, video, and audio files), as required.
• Own, coordinate, and maintain project timelines, working closely with internal research teams, clients, and suppliers.
• Take ownership of coordinating project team meetings, including scheduling and facilitation.
• Hold responsibility for Pharmacovigilance and Adverse Event reporting, ensuring compliance with internal and regulatory standards.
• Coordinate client and supplier Statements of Work (SOWs).
• Manage client and supplier invoicing, including PO number tracking, invoice coordination, and liaison with the Finance team.

Team Leadership & Line Management

• Line manage a team of RP Project Managers and Senior Project Managers.
• Provide coaching, feedback, and development support to strengthen project management capability and consistency of output.
• Support professional development and performance management of RP PMs.

Client Engagement

• Engage directly with clients on escalations, delivery challenges, and complex projects.
• Act as a senior point of contact for project delivery matters when required.
• Partner with internal stakeholders to support strong, long-term client relationships.

RP & STEM Alignment within Insights

• Work closely with the Head of US Field Operations to build a strong understanding of RP and STEM as distinct businesses.
• Support the alignment and clarification of project management roles and responsibilities across RP and STEM within Insights.
• Contribute to discussions on how project management capabilities and expectations can be enhanced and aligned over time, while recognizing existing team processes.
• Act as a bridge between RP project management and the wider Insights Field Operations organization.

Global Collaboration

• Collaborate with Associate Project Directors in the UK and APAC to support alignment of RP project management approaches globally.
• Share best practices and support consistent quality of project output across geographies.
• Contribute to global discussions on project management standards and ways of working for RP within Insights.

About You…

Your skills and experience:

• More than 7 years of experience in market research project management (qualitative and/or quantitative research)
• Experience managing healthcare market research projects
• Significant experience with team management (including line management and training of a team of junior Project Managers)
• Established relationships with fieldwork agency suppliers
• Strong project management skills (adhering to agreed timelines, troubleshooting and communication with internal and external stakeholders)
• Proven ability to manage complex, multi-stakeholder projects and make independent delivery decisions.
• Experience handling client escalations and operating confidently in senior client environments.
• Comfortable working across teams and geographies and contributing to organizational alignment efforts.
• Highly organized, detail-oriented, and able to balance delivery with people leadership.

Ideal profile:

• You are proactive, dedicated and enthusiastic, with a ‘can do’ attitude and approach
• You demonstrate commercial and analytical capabilities
• You demonstrate a high level of accuracy and attention to detail, as well as strengths in organization and prioritization
• You demonstrate a track record of identifying operational efficiencies
• You are a collaborative team player who works well with colleagues
• You communicate ideas and issues in an effective, straightforward fashion
• You are highly motivated and want to seize opportunities to develop new skills and progress your career

Life at Research Partnership:

We love what we do and continuously strive for innovation and creativity. We believe everyone should continuously be learning and provide:

• A comprehensive training and development program for all staff, from entry level apprentice to senior management
• A relaxed and friendly working environment
• Social events - including a summer day out and end-of-year party, along with regular social events after office hours

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a Senior/Clinical Research Associate. 

Position Summary:

The CRA provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience for CRAII; 1 year oncology and Phase I experience preferred. 

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a Senior/Clinical Research Associate. 

Position Summary:

The CRA provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience for CRAII; 1 year oncology and Phase I experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Argentina!

As a Senior CRA you'll posses a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

• Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
• Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Communicates effectively and proactively with both site personnel and Precision's Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools
• Assists the team managers in the preparation and review of protocols and other study documentation
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
• Assists with review of clinical study reports
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors
• Interacts with client, participates in proposal activities, including development and client presentations
• Initiates payment requests for investigators
• Travels as necessary according to project needs
• Other job duties as assigned 

Minimum Education & Experience: 

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience:

• Graduate, postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Select opportunities require Oncology experience preferably in early phases
• Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Argentina!

As a Senior CRA you'll posses a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

• Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
• Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Communicates effectively and proactively with both site personnel and Precision's Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools
• Assists the team managers in the preparation and review of protocols and other study documentation
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
• Assists with review of clinical study reports
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors
• Interacts with client, participates in proposal activities, including development and client presentations
• Initiates payment requests for investigators
• Travels as necessary according to project needs
• Other job duties as assigned 

Minimum Education & Experience: 

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience:

• Graduate, postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Select opportunities require Oncology experience preferably in early phases
• Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a CRA II (Based in Shanghai/Beijing)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology trial experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an CRA II (based in Shanghai and Beijing or Taiwan)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Position Summary:
The CRA II is a seasoned, experienced professional in monitoring and site management. Responsibilities will be dependent upon the type and timing of the program to which the CRA II is assigned and typically include activities involving start-up and study implementation, on-site monitoring of clinical research studies as well as on-going site management. Incumbents work independently as a study team member. 

Essential functions of the job include but are not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies.
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required: 

•  4-year college degree or equivalent experience in a scientific or healthcare discipline.
• Two (2) years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research

Other Required:

• Excellent communication and organizational skills are essential. A team player.
• Experience monitoring oncology trials
• Evidence of a client focused approach
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed.
• Fluency in English and for non-English speaking countries the local language of country where position based

Preferred:

• Graduate or postgraduate degree
• Auto-immune monitoring experience
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
• Ability to resolve project related problems and prioritizes workload to meet deadlines with minimal support from management.

Competencies:

• Exhibits self-motivation and is able to work and plan independently as well as in a team environment
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
• Demonstrates professionalism as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
• Collects data of consistently high standard
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including, colleagues, investigative staff, and clients with a high level of proficiency
• Fluency in English and for non-English speaking countries the local language of country where position based

Position Summary:

The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

 Essential functions of the job include but are not limited to:

• Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
• Maintain various spreadsheets, including but not limited to distribution/submission trackers
• Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
• Prepare and distribute final submission documents, including Investigator Safety Letter
• Perform case closure and electronic filing of SAE related documentation
• Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
• Perform SAE reconciliation and send queries, as appropriate
• Reconcile and send SUSAR Gap Packs
• Maintain and update expedited email distribution lists
• Reconcile compliance metrics
• Support generation of overall distribution/submission compliance metrics
• Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings

Qualifications:

Minimum Required:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
• Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
• BA/BS preferred

Position Summary:

The Safety Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

 Essential functions of the job include but are not limited to:

• Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
• Maintain various spreadsheets, including but not limited to distribution/submission trackers
• Generate final clinical trial regulatory reports (e.g., CIOMS I, MedWatch 3500A, XML) from the global safety database for distribution/submission
• Prepare and distribute final submission documents, including Investigator Safety Letter
• Perform case closure and electronic filing of SAE related documentation
• Complete expedited report deviations which includes initiation, investigation, extension requests, and CAPAs, as appropriate
• Perform SAE reconciliation and send queries, as appropriate
• Reconcile and send SUSAR Gap Packs
• Maintain and update expedited email distribution lists
• Reconcile compliance metrics
• Support generation of overall distribution/submission compliance metrics
• Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process
• Attends Department meetings

Qualifications:

Minimum Required:

• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
• Knowledge of the ARGUS Safety Database
• Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
• Experience with EMA EudraVigilance, UK MHRA and other recognised reporting portals
• BA/BS preferred

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for an Senior / CRA  (based in HongKong)

Position Summary:

The CRA  provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology experience； 
• Global Clinical Trial experience

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Precision for Medicine is not your typical CRO.  At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients.  What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.

Precision for Medicine is looking for a CRA II (Based in Shanghai/Beijing)

Position Summary:

The CRA II provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH) -Good Clinical Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as point of contact for study sites. The CRA is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. Individual works independently as study team member with minimum support in complex activities.

Essentials functions of the job included but not limited to:

• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Updates, tracks and maintains study specific trial management tools/systems, and status reports.
• If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager.
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote).
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image.
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process.
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Travels as necessary according to project needs.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 2 years of on-site monitoring experience; 1 year oncology trial experience preferred

Other required:

• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour; demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Preferred:

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

Competencies:

• Good knowledge and utilization of ICH-GCP, Precision SOPs, and regulatory guidance.
• Demonstrates solid interpersonal skills.
• Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
• Good written and verbal communication skills and presentation skills.
• Ability to deliver on commitments.
• Commitment to performing professionally consistent with Precision Principles.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

The Role:

The Clinical Development Leader – Neurology is a key role within Immunovant’s Neurology portfolio. This Clinical Development Leader will lead clinical trials for one or more of Immunovant’s development programs in neurology. Specifically, this role will be directly responsible for Immunovant’s ongoing major study for IMVT-1402 in CIDP.

For this critical position, the Clinical Development Leader will be the primary point person for medical oversight of clinical studies with responsibilities to include clinical trial design, site feasibility assessment, protocol development, clinical trial enrollment, sponsor medical monitoring, review, and interpretation of clinical trial data, drafting key clinical documents such as protocol, CSR, briefing package, IND, NDA, BLA, etc. This role will be responsible for timely execution of deliverables in close collaboration with relevant internal and external partners.

The successful candidate is driven, curious, patient focused, collaborative, with a bold ambition to contribute to Immunovant’s mission to enable normal lives for people living with autoimmune diseases.

Key Responsibilities: 

• Provide clinical scientific leadership for the clinical study team.
• Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, regulatory affairs, etc.
• Provide medical safety oversight of CRO medical monitors.
• Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.
• Collaborate closely with partners in Clinical Operations and be accountable for clinical trial conduct and timelines for associated key deliverables.
• Lead the design and writing of clinical protocols and associated clinical documents.
• Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
• Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
• Assume primary responsibility for presentations related to clinical trial data and assist in the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
• Contribute to the writing of manuscripts and publications.
• Comply with Immunovant's SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
• Provide medical leadership for internal audits and regulatory inspections.
• Assist in preparation of materials for Advisory Board meetings, IMVT BOD meetings, etc.
• Develop and maintain strong, collaborative relationships with the broader Immunovant organization.
• Represent Immunovant externally and build successful relationships with multiple stakeholders including trial site Investigators, KOLs, and others.
• Excellence in verbal and written communication, teamwork, and collaboration is a must.

Requirements:

• A minimum of 8 years’ experience in early to late-stage development in an industry (CRO and/or Pharma) setting.
• Proven ability to: Plan and conduct clinical trials.
• Deliver high-quality results within established timelines.
• Demonstrated track record in working effectively in cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).
• Prior late phase clinical trial experience in neurology is highly desirable.
• Ability to thrive in a fast-paced environment.
• Proven ability to successfully manage multiple tasks and prioritize accordingly.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Excellent analytical, problem-solving, and strategic planning skills.
• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
• Exceptional written and oral communication skills to meet the needs of varied audiences.
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies would be desirable.

Education

• MD, DO, or non-US equivalent of MD degree.
• Board certification in Neurology is strongly preferred.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (20%)

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director, PV Operations will provide vendor oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be responsible for PV operations’ role in Phase 1, 2, & 3 clinical studies, inclusive of inspection readiness, reconciliation, SMP maintenance, and site and regulatory authority reporting oversight. They will work in close collaboration with PV physicians and PV scientists on operational safety and case quality issues.

Responsibilities:

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
• Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• Review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions within the company for pharmacovigilance
• operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation
•  
• Responsible for the development of safety management plans for assigned programs, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow responsibilities between CROs, and Nuvalent are clearly delineated and adhered to

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related fields.
• 8-10 years of progressive drug safety experience in a biotech/pharma company.
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.
• Direct experience managing relationships with service providers or external business partners

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

About Every Cure:   

Every Cure is an AI-driven nonprofit, biotech organization on a mission to save and improve lives by repurposing existing medicines for diseases with significant unmet need. We are working to create a world where every drug is used to treat every disease it possibly can, so that no patient suffers when an existing treatment could help them. We are filling a gap left by the current biomedical system, which doesn’t systematically pursue new uses for old drugs. Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can. Inspired by Every Cure’s co-founders' work repurposing drugs for Castleman disease and other rare diseases, Every Cure is advancing repurposed treatments for neglected diseases and has been featured in The New Yorker,  New York Times, USA Today, Good Morning America and other news media. Led by a talented leadership team and an outstanding Board of Directors, Every Cure is supported through funding from leading philanthropic organizations like Chan Zuckerberg Initiative, TED’s Audacious Project, and ARPA-H. 

 Our approach:  

• AI-Powered Identification: We use advanced artificial intelligence to analyze the world’s biomedical knowledge and identify FDA-approved drugs that can be repurposed for untreated conditions. This cutting-edge technology enables us to explore new therapeutic possibilities efficiently.  
• Open-Source Commitment: We are dedicated to making our predictive pipeline open-source, fostering collaboration and transparency within the scientific community and unlocking the potential for discovering new treatments.  
• High-Impact Focus: We prioritize drug repurposing opportunities that will relieve the most suffering and have the greatest impact possible.  
• Rigorous Validation: Promising opportunities are thoroughly validated through laboratory and clinical studies to confirm their efficacy and safety before advancing to broader application.  
• Strategic Marketing and Access: We disseminate information about effective repurposed treatments through multiple channels and are committed to ensuring that new cures are accessible to all patients.

Applicants must reside in the state specified at the top of this job posting. Residency in that state is a requirement for consideration and must be maintained for the duration of employment.

The Head of Clinical Development leads Every Cure’s clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement  and oversees regulatory strategy and dissemination. The HCD supports Every Cure’s CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.

How you will make an impact: 

Strategic Leadership of Clinical Development and Medical Affairs

• Set the direction for Every Cure’s clinical research and development, ensuring alignment with the organization’s mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
• Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
• Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.

Research and Clinical Development Oversight

• Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
• Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
• Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
• Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).

Portfolio Strategy and Program Management

• Partner on strategic prioritization and dynamic management of Every Cure’s diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
• Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
• Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.

Leadership and Team Development

• Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
• Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
• Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.

Stakeholder Engagement, Compliance, and Dissemination

• Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization’s mission and sharing results from preclinical and clinical programs.
• Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
• Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
• Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.

What you bring to the team:

Education 

• MD or MD/PhD preferred; PhD DO, or PharmD acceptable

Work Experience (Two-Tier: Head of / VP)

• Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
• Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
• Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
• Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
• Experience working across more than one therapeutic research area.
• Experience with small-sample trial designs and natural history or registry data.
• Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.

Preferred for Vice President designation:

• 12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.

Skills 

• Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
• Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
• Exceptional communication and presentation abilities.
• Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
• Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
• Strategic thinker with a focus on urgency, efficiency, and impact.
• Passionate about Every Cure’s mission and values.
• Highly adaptable, thriving in a fast-paced, start-up environment.
• Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.

Compensations & Benefits: 

• Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually. 
• Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses. 
• Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future. 
• Relax and recharge: Generous time off, including paid time off and paid holidays. 
• We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times. 

This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office.  

Every Cure is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, or any other characteristic protected by federal, state, or local laws.

Compliance Manager

FLSA Status: Exempt

JOB SUMMARY:

The Compliance Manager performs a vital role in Snow Companies’ overall regulatory compliance, enforcement, and implementation of strict standard business practices to ensure that the client services delivered by Snow are of the highest quality. The Compliance Manager reports to the VP, Compliance Operations.

Snow’s business is centered around the patient journey, and the Compliance Manager, like all positions at Snow, must be open, compassionate, and sensitive to the unique life experiences of these patients and caregivers. The Compliance Manager must be able to incorporate the unique patient/caregiver experience into the strategies and solutions we provide to our clients.

ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES:

The Compliance Manager must be able to perform the following essential duties and functions:

• Manage and maintain contract documents:
  • track key dates (expiration)
  • oversee Master Services Agreements (MSA) review, approval, and signing
  • update M files (executed contracts repository) with completed MSAs
  • maintain MSA Management spreadsheet
  • maintain MSA database
  • oversee finalization and receipt of ancillary agreements (DPAs, PV/safety agreements, data sharing agreements, travel/expense policies, etc.)
  • maintain business development (BD) contract files (Euler grade, Non-Disclosure Agreements, MSA drafts)
• Coordinate with OMC Risk Management for review of MSA insurance terms
• Coordinate with Snow Privacy and Compliance for review of Data Privacy Agreement (DPA), privacy, and Pharmacovigilance (PV) terms
• Maintain Statement of Work (SOW) library
• Assist finance with new client onboarding
• Submit Certificate of Insurance (COI) requests
• Coordinate workflow between internal departments (finance, legal, compliance, BD, account services)
• Review/approve CSC (corporate filing) invoices
• Administer Snow Standard Contract Templates (NDAs, Ambassador Agreements, Print/Film Releases, Waiver of Honoraria, etc.)
• Liaise with Ambassador Services to execute Ambassador Contract requests
• Execute Snow’s Individual Rights Request Process
• Work with Snow’s Client Finance and Account teams to review SOWs as needed
• Recommend changes that will improve quality and efficiency and reduce cost

The primary job functions and responsibilities include, but are not limited to, those listed above

Weekend and Night Work:

Although your day-to-day work should primarily take place during regular office hours (8:30 a.m.–6:00 p.m., Monday–Friday), there will be occasions when you are required to work late into the evening and/or over the weekend. The candidate selected for the Compliance Manager position should have the expectation that the workload and nature of the work will require hours that may extend past the normal business hours of the company. This includes working on the weekends.

Flexibility:

The core business hours that you work may change based on business needs, and shifts may change from time to time.

Collaboration/Teamwork:

The size and nature of our company will require that you work in collaboration with people in other departments. Candidates must demonstrate their willingness/ability to step into other roles as needed to drive the success of the company. Candidates will need to demonstrate their ability to be a contributing member of a team that has goals that are broader than an individual job description or function.

Patient Privacy:

The core of our business is working with patients. It is most likely that you will come in contact with Personal Consumer Information (PCI) of patients living with chronic illness. It will be required that you take training courses that include, but are not limited to:

• Snow Policy Training
• Health Insurance Portability and Accountability Act (HIPAA)
• Adverse Event (AE) Reporting Training

Requirements/Qualifications:

• Strong attention to detail
• Excellent technical, business, and people skills
• Well-organized and flexible to meet continuously changing priorities and challenges
• Excellent project management skills in times of urgency
• Demonstrated ability to meet deadlines, handle and prioritize simultaneous requests, and manage laterally and upward with a positive attitude
• Current/past experience as a paralegal or contracts manager preferred
• Bachelor's degree or equivalent related experience in business or technology

Compliance Manager

FLSA Status: Exempt

JOB SUMMARY:

The Compliance Manager performs a vital role in Snow Companies’ overall regulatory compliance, enforcement, and implementation of strict standard business practices to ensure that the client services delivered by Snow are of the highest quality. The Compliance Manager reports to the VP, Compliance Operations.

Snow’s business is centered around the patient journey, and the Compliance Manager, like all positions at Snow, must be open, compassionate, and sensitive to the unique life experiences of these patients and caregivers. The Compliance Manager must be able to incorporate the unique patient/caregiver experience into the strategies and solutions we provide to our clients.

ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES:

The Compliance Manager must be able to perform the following essential duties and functions:

• Manage and maintain contract documents:
  • track key dates (expiration)
  • oversee Master Services Agreements (MSA) review, approval, and signing
  • update M files (executed contracts repository) with completed MSAs
  • maintain MSA Management spreadsheet
  • maintain MSA database
  • oversee finalization and receipt of ancillary agreements (DPAs, PV/safety agreements, data sharing agreements, travel/expense policies, etc.)
  • maintain business development (BD) contract files (Euler grade, Non-Disclosure Agreements, MSA drafts)
• Coordinate with OMC Risk Management for review of MSA insurance terms
• Coordinate with Snow Privacy and Compliance for review of Data Privacy Agreement (DPA), privacy, and Pharmacovigilance (PV) terms
• Maintain Statement of Work (SOW) library
• Assist finance with new client onboarding
• Submit Certificate of Insurance (COI) requests
• Coordinate workflow between internal departments (finance, legal, compliance, BD, account services)
• Review/approve CSC (corporate filing) invoices
• Administer Snow Standard Contract Templates (NDAs, Ambassador Agreements, Print/Film Releases, Waiver of Honoraria, etc.)
• Liaise with Ambassador Services to execute Ambassador Contract requests
• Execute Snow’s Individual Rights Request Process
• Work with Snow’s Client Finance and Account teams to review SOWs as needed
• Recommend changes that will improve quality and efficiency and reduce cost

The primary job functions and responsibilities include, but are not limited to, those listed above

Weekend and Night Work:

Although your day-to-day work should primarily take place during regular office hours (8:30 a.m.–6:00 p.m., Monday–Friday), there will be occasions when you are required to work late into the evening and/or over the weekend. The candidate selected for the Compliance Manager position should have the expectation that the workload and nature of the work will require hours that may extend past the normal business hours of the company. This includes working on the weekends.

Flexibility:

The core business hours that you work may change based on business needs, and shifts may change from time to time.

Collaboration/Teamwork:

The size and nature of our company will require that you work in collaboration with people in other departments. Candidates must demonstrate their willingness/ability to step into other roles as needed to drive the success of the company. Candidates will need to demonstrate their ability to be a contributing member of a team that has goals that are broader than an individual job description or function.

Patient Privacy:

The core of our business is working with patients. It is most likely that you will come in contact with Personal Consumer Information (PCI) of patients living with chronic illness. It will be required that you take training courses that include, but are not limited to:

• Snow Policy Training
• Health Insurance Portability and Accountability Act (HIPAA)
• Adverse Event (AE) Reporting Training

Requirements/Qualifications:

• Strong attention to detail
• Excellent technical, business, and people skills
• Well-organized and flexible to meet continuously changing priorities and challenges
• Excellent project management skills in times of urgency
• Demonstrated ability to meet deadlines, handle and prioritize simultaneous requests, and manage laterally and upward with a positive attitude
• Current/past experience as a paralegal or contracts manager preferred
• Bachelor's degree or equivalent related experience in business or technology

What You’ll Do: 

The Safety Scientist will be responsible for high quality safety surveillance activities including medical review of individual case safety reports (ICSRs), aggregate report production, safety governance meeting coordination, safety signal detection and assessment, and safety risk management activities for assigned products. This individual will collaborate with Program Safety Lead and other program team members, pharmacovigilance operations, and CROs to ensure proactive safety surveillance in compliance with global regulations. 

Responsibilities:

• Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, track signals and related documentation)
• Represent PV at clinical study team for assigned product
• Develop signal assessment report under the oversight of Program safety lead for validated safety signal
• Collaborate with PV operations for timely and accurate medical review of ICSRs for assigned clinical study as needed
• Develop and contribute safety risk management plan across product lifecycle
• Develop and manage periodic reports (DSUR/PBRER)
• Contribute for data analysis and authoring of safety sections for regulatory submissions and regulatory responses
• Contribute for the development or updates of safety surveillance and risk management SOPs, templates etc.
• Collaborate with clinical study teams on safety surveillance deliverables (IB, RSI, Protocol, Briefing documents etc.)
• Participating in PV audit and inspections
• Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.

We consider these behaviors we seek in all MapLight employees.

• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understanding relationships are key to being successful.
• You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
• You’re a team player who is willing to roll up your sleeves and get the job done.

Qualifications:

• Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science.
  • Preferred: Post-graduate training in epidemiology (e.g. MPH)
• Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years of direct clinical/patient care experience
  • Preferred: Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease area
• Competence in conducting safety data reviews, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post-marketed products
• Experience with MedDRA and drug coding reviews
• Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
• Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
• Exceptional communication and cross-functional collaboration skills
• Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making
• Able to work within a growing organization and to help the organization evolve over time
• Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect
• Highly motivated, self-driven and dependable
• Committed to MapLight's Core Beliefs and Values

Location:   This is a remote US position.  Hybrid 3 day in office policy for anyone located within 50 miles of Redwood City, CA or Burlington, MA.  

Travel: Ability to travel as needed (up to 10%) for corporate and departmental meetings.

EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

The Opportunity:

We are seeking a skilled senior safety systems analyst to join our dynamic Global Patient Safety (GPS) department.  The Sr. Systems Analyst position supports the configuration, maintenance, and continuous improvement of the GPS systems and related technologies. This role serves as a key contributor in ensuring data quality, system reliability, and operational efficiency across pharmacovigilance processes.

The Sr. Systems Analyst collaborates closely with cross‑functional partners, vendors, and internal GPS stakeholders to troubleshoot issues, extract and format data, execute configuration updates, and support enhancements that enable scalable, inspection‑ready safety operations.

The successful candidate will be a proactive, detail oriented, team player who exhibits technical proficiency with best-in-class pharmacovigilance systems. The candidate will meet the following requirements:

System Configuration & Administration

• Key contributor to system upgrades and ongoing maintenance through the development of system user and functional requirements, qualification scripts, and other validation deliverables.

• Effectively communicate and coordinate with internal and external stakeholders to gather and implement requirements.

• Execute routine system configuration updates to support evolving safety processes and business requirements.

• Maintain user roles, permissions, and access controls in alignment with governance standards.

• Key contributor to system validation activities including documentation, testing, and change‑control processes.

• Troubleshoot system issues and coordinate resolution with internal teams and external vendors.

Data Quality & Reporting Support

• Perform data extractions from the safety database, ensuring accurate and timely distribution to key stakeholders.

• Format safety output (line listings, tables, graphs) to support regulatory reporting and business‑partner inquiries.

• Experience with safety dashboards and analytics, including operational metrics, signal detection analyses, and compliance monitoring reports, to support operational insights and decision‑making.

• Facilitate routine data‑quality checks to ensure accuracy, completeness, and regulatory readiness.

• Investigate data discrepancies and partner with stakeholders to resolve root causes.

Operational Support & Collaboration

• Serve as a technical resource for GPS users, providing guidance on system functionality and best practices.

• Participate in continuous improvement initiatives through innovative technology solutions and process enhancements.

• Work collaboratively with Safety Operations, Safety Science, and other departments to ensure pharmacovigilance system compliance and best in class operations.

• Participate in cross‑functional projects involving system enhancements, integrations, and process improvements.

• Understand integrations between safety systems and upstream/downstream platforms.

• Document system processes and SOP inputs to support operational consistency and compliance.

• Support vendor coordination for issue resolution, enhancement requests, and release planning.

Compliance & Inspection Readiness

• Conduct safety system training to ensure common understanding of features and functionality, as well as Revolution Medicine’s consistent and proper use of the system.

• Prepare for global inspections by ensuring all processes and trainings reflect global regulatory requirements.

• Ensure system activities align with GxP expectations and internal quality standards.

• Ensure all safety systems and processes comply with global regulatory requirements including FDA, EMA, PMDA, and other relevant authorities.

• Maintain audit‑ready documentation for configuration changes, testing, and data‑quality activities.

• Support inspection and audit requests by preparing data outputs, evidence of system validation, and responding to technical inquiries.

Required Skills, Experience and Education:

• Bachelor’s degree in a scientific, technical, or related field required. At least 5 years in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry regarding pharmacovigilance safety databases, safety reporting systems, and data analysis tools.

• Hands‑on experience with safety databases and systems (e.g., Safety One Argus, Empirica Signal, Veeva Safety Docs) or similar regulated systems.

• Proficiency in data tools such as SQL, Spotfire, Oracle Analytics Server, or equivalent.

• Awareness of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).

Core Competencies

• Strong analytical, problem-solving, and decision-making skills, with the ability to interpret complex safety data to make informed decisions.

• Clear and concise communication with technical and non‑technical stakeholders.

• Ability to manage multiple priorities in a fast‑paced environment.

• Collaborative mindset with a focus on partnership and service delivery.

• Commitment to quality and compliance in all system‑related activities.

• Foster a structured and efficient work environment.

• Excellent written and verbal communication skills, with the ability to effectively liaise with internal and external stakeholders.

• Proven ability to think strategically, drive innovation, and implement process improvements.

Preferred Skills:

• Degree in computer science or related field preferred.

• Working knowledge of pharmacovigilance processes including case processing, ICSR and aggregate reporting, and electronic data exchanges.

• Experience interacting with regulatory agencies and participating in regulatory inspections and audits.  

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Executive Director of GCP QA is a senior leadership role responsible for setting and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and company policies governing clinical trials. The role provides strategic oversight of GCP QA activities, including leadership of a high-performing QA team, governance of contract research organizations, and advancement of continuous improvement initiatives to uphold the highest standards of quality and patient safety.

Serving as the GCP QA lead for late-stage clinical programs, this individual is accountable for GCP, GLP, and Pharmacovigilance/Safety oversight across multiple RevMed studies and represents QA in cross-functional and executive forums. The Executive Director will serve as a key advisor to senior leadership on clinical quality risk and regulatory readiness, helping to shape development strategy and enable successful regulatory outcomes. This position reports to the Vice President, Global Quality.

Key Responsibilities:

• Develop and execute the global GCP QA strategy aligned with corporate objectives, regulatory requirements, and RevMed SOPs.

• Serve as the Clinical QA Lead for global Phase 2/3 oncology studies, representing QA in governance forums and providing decision-making oversight on GCP related matters.

• Establish and maintain GCP QA frameworks, including policies, procedures, systems, and risk-based quality management (RBQM) to ensure compliance with global regulations (FDA, EMA, ICH).

• Provide end-to-end QA oversight of clinical studies, including:

• Review and approval of key study documents (protocols, monitoring plans, vendor oversight plans, quality agreements)

• Trial Master File (TMF) quality and inspection readiness

• GxP computerized systems and data integrity controls

• Lead and oversee GCP audit and inspection activities, including investigator sites, vendors, internal processes, and regulatory inspections (e.g., BIMO, PV), ensuring timely resolution of findings and CAPAs.

• Serve as the primary QA interface with global regulatory authorities, leading inspection strategy and representing the organization during health authority interactions.

• Drive global inspection readiness through structured planning, mock inspections, and cross-functional preparedness activities to support successful regulatory submissions and approvals.

• Oversee vendor and CRO quality management, including selection, qualification, governance models, performance monitoring (KPIs), and compliance with quality agreements.

• Proactively identify and mitigate systemic quality risks across the clinical portfolio, influencing development strategies and ensuring effective escalation to senior leadership.

• Monitor, trend, and report quality metrics (e.g., KPIs, QTLs, TMF health, CAPAs), leveraging insights to drive continuous improvement and operational excellence.

• Provide QA oversight of pharmacovigilance activities, ensuring compliance with safety reporting requirements and vendor performance expectations.

• Partner cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Pharmacovigilance to drive quality, compliance, and continuous improvement.

• Drive innovation in QA through adoption of digital tools, advanced analytics, and modern risk-based quality approaches.

• Build, scale, and lead a high-performing global GCP QA organization, fostering a culture of quality, accountability, and operational excellence.

• Serve as a subject matter expert on GCP/GLP/PV regulations, advising senior leadership and influencing quality strategy across the organization.

Required Skills, Experience and Education:

• Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, including at least 10 years in GCP QA or clinical quality leadership roles, with demonstrated experience leading and hosting regulatory inspections (e.g., FDA BIMO, EMA, MHRA, PMDA).

• Demonstrated experience interacting directly with global health authorities and leading inspection strategy and execution.

• Experience supporting late-stage clinical development and regulatory submissions (e.g., NDA, MAA), preferably in oncology.

• Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.

• Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.

• Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.

• Analytical thinker with a focus on continuous improvement and innovation.

• Experience working within outsourced clinical trial models and managing global CRO/vendor networks is highly desirable.

• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.

• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills:

• Experience implementing advanced RBQM frameworks and leveraging analytics-driven approaches (e.g., centralized monitoring, signal detection) to enhance clinical quality oversight.

• Prior experience in a small-to-mid-size biotech environment, with demonstrated ability to build and scale QA functions within highly outsourced, global clinical development models. 

  #LI-Hybrid  #LI-GL1

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

The Senior Director, FP&A will be a key business partner to Ultragenyx’s Development organization, with primary responsibility for strengthening financial governance, budget transparency, and accrual rigor across development activities. The position supports the Chief Medical Officer and senior Development leadership by enabling a clear, consistent understanding of spend to date, remaining budget, and forward‑looking financial exposure across clinical and non‑clinical functions. The role combines hands‑on analytical execution with executive‑level financial storytelling to improve confidence, decision‑making, and stewardship across the development portfolio. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Establish and maintain strong working relationships with Development leadership and operational stakeholders, serving as a trusted finance partner embedded in clinical study governance, financial oversight, and execution forums.  
2. Provide hands‑on financial support to Program Teams and Development functions by reviewing invoices, tracking actual spend, and identifying total and remaining budget at the study, program, and functional levels.  
3. Lead clinical trial cost modeling, including scenario planning and sensitivity analyses, clearly explaining cost drivers related to study design, timelines, enrollment assumptions, and execution strategies.  
4. Perform regular budget‑to‑actual analyses across clinical and non‑clinical Development activities, synthesizing account‑level, vendor‑level, and study‑level variances into concise, decision‑oriented insights.  
5. Deliver clear, actionable financial updates on spend, forecast changes, risks, and opportunities to minimize surprises and strengthen confidence in Development financial outlooks.  
6. Partner with Accounting and operational teams to support Development accrual processes, ensuring assumptions are timely, well‑documented, and aligned with underlying operational activity.  
7. Lead financial communications related to clinical trials and broader Development spend, including inputs to executive‑level readouts, portfolio reviews, and CMO‑level presentations.  
8. Support annual planning and in‑year reforecasting cycles by reviewing business‑generated forecasts, assessing reasonableness, and providing Development‑wide financial context and challenge.  
9. Design, implement, and continuously improve financial tools, reporting, and processes that enhance budget visibility, accrual understanding, and financial fluency across Development teams.  
10. Balance near‑term execution and stewardship of existing processes with a longer‑term focus on strengthening governance frameworks, standardization, and transparency across Development financial management. 

Requirements:

1. Bachelor’s degree in finance, Accounting, Economics, or a related discipline; MBA, CPA, or advanced degree preferred.  
2. Minimum of 12 years of progressive experience in FP&A, finance, or financial management supporting R&D or development organizations within the biotechnology, pharmaceutical, or life sciences industry.  
3. Demonstrated experience partnering with Development teams, including Clinical Operations and non‑clinical functions such as Regulatory, Pharmacovigilance, Biostatistics, and Statistical Programming.  
4. Deep expertise in clinical trial financial modeling, including cost drivers, scenario planning, and sensitivity analysis, with the ability to translate operational assumptions into credible forecasts.  
5. Strong background in financial governance, including budget oversight, variance analysis, accrual support, and spend‑to‑date transparency.  
6. Proven ability to influence without formal authority and partner effectively with senior leaders, program teams, and functional stakeholders.  
7. Ability to operate seamlessly between strategic and detailed perspectives, including hands‑on engagement with invoices, actuals, and accrual drivers, as well as executive‑level synthesis.  
8. Demonstrated success leading process improvement initiatives that improve budget visibility, accrual rigor, and financial fluency within business teams.  
9. Strong communication skills, with the ability to deliver clear, concise summaries of variances, forecast changes, and drivers to audiences ranging from study teams to executives.  
10. Advanced proficiency in financial modeling, forecasting, and analytics tools (e.g., Excel, Adaptive Insights, and enterprise planning systems) 

#LI-CK1 #LI-Hybrid

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

The Associate Director, Clinical Scientist at Calico is responsible for the planning and execution of the translational and clinical development plans and protocols for several projects across therapeutic areas, related to Calico’s mission to improve human healthspan by understanding aging and age-related diseases. The successful candidate will participate in and drive the development of clinical strategies for assigned program(s)/indication(s) and should be able to support novel and innovative clinical plans while ensuring a positive and collaborative team environment.

Responsibilities:

• In coordination with the Head of Clinical Science and/or Medical Director(s), leads or represents the Clinical Science function in cross-functional project and study teams that develop and execute the clinical development plan to translate preclinical mechanistic data to humans for novel aging-related targets
• Authors clinical sections of assigned protocols from Phase 0 through Phase 2, collaborating with other functions required for protocol development, including Research, Biomarkers, Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Biometrics, Pharmacovigilance, Toxicology, and Medical Writing
• Contributes to the design and execution of experimental medicine studies to demonstrate proof-of-mechanism of novel targets in aging and age-related diseases
• Interfaces with academic investigators to assist in execution of Investigator initiated trials
• Contributes to and/or reviews relevant study documents including Investigational Brochures, Clinical Study Reports, Statistical Analysis Plans, Operations/Technical Manuals, IND/CTAs, case report forms and data tables, listings and figures, CSRs
• Trains CROs and study site personnel on assigned protocols and addresses protocol queries as they arise
• Participates in the assessment of CROs and study vendors

Position Requirements:

•  BS/MS in a relevant scientific discipline with 8+ years or PhD/PharmD with 5+ years of experience in early clinical drug development in the biotech/pharmaceutical industry performing the responsibilities described above
• Experience in early clinical trial methodology (Phase 0, Phase 1, Phase 2) and knowledge of drug development process and clinical deliverables from IND through clinical proof-of-concept
• Excellent understanding of clinically relevant ICH GCP guidance, FDA and EMA regulations
• Ability to perform role responsibilities largely independently
• Proven leadership skills and ability to bring out the best in others on a cross-functional team
• Able to provide effective leadership through influence across organizations on partnered programs
• Detail-oriented mindset with excellent oral and written English communication skills 
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $238,000 - $245,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Location: Kansas City Metropolitan area or the Florida Panhandle, near Pensacola, FL
Reports to: Director of Clinical Affairs & Vet Services
Travel: Up to 75%

Position Summary 

At PRN Pharmacal, we believe in thinking and acting like owners—because we are. As an employee-owned company, we are driven by accountability, innovation, and a shared commitment to advancing animal health. 

As a Medical Affairs Director, you will leverage your advanced clinical expertise to address unmet needs in veterinary medicine while contributing to your own long-term growth through our employee-owner stock option plan. This role supports our mission to empower commercial teams and veterinary clients through expert education, evidence-based insights, and collaborative communication—enabling confident, informed decision-making that elevates patient care within the veterinary specialty pharmaceutical market. 

The Opportunity 

In this highly collaborative role, you will serve as a clinical leader focused on the education of veterinarians in disease state awareness, diagnosis, and management—particularly within cardiovascular conditions affecting companion animals. You will work closely with cross-functional field teams and act as a trusted clinical advisor to business leadership, providing strategic input on both commercialized products and the future development pipeline. 

 Compensation & Benefits 

• Employee Ownership (ESOP): Company-funded retirement contribution of approximately 18% of pay, plus 401(k) 
• Competitive base salary with performance-based bonus opportunity 
• Comprehensive benefits package: Medical, Dental, Vision, Life, Disability, FSA, and Pet Insurance 
• Generous paid time off, paid holidays, and parental leave 
• Fitness and tuition reimbursement programs

Essential Duties & Responsibilities

• Serve as a trusted clinical advisor and subject matter expert for internal and external stakeholders, including employee-owners, veterinary professionals, key opinion leaders, and corporate partners. 
• Communicate objective, evidence-based product information and best-practice medicine to support treatment guidelines, brand strategies, and business objectives. 
• Mentor Sales Force Leadership and Professional Service Veterinarians to achieve aligned clinical and commercial goals at both regional and territory levels. 
• Represent the organization as a credible and engaging speaker across diverse forums, ranging from small-group discussions to major national and international conference presentations, focused on unmet disease states in companion animal medicine. 
• Build and sustain strong professional relationships with general practitioners, specialists, academic institutions, and industry leaders. 
• Actively participate in professional and specialty organizations through committee involvement, board service, and invited speaking engagements. 
• Collaborate with research and development teams on study design, in-life assessments, and evaluation of emerging clinical trends, serving as the “voice of the veterinarian.” 
• Perform additional responsibilities as assigned to support organizational objectives. 

Required Qualifications

• Doctor of Veterinary Medicine (DVM/VMD) or equivalent degree 
• Diplomate status from an accredited veterinary specialty board (e.g., ACVIM, ACVS, ACVSMR, ACVECC, ACVB, ABCB) or recognized feline specialty practitioner 
• Minimum of 8 years of relevant professional experience, ideally including at least 5 years in an industry-based professional services role 
• Demonstrated ability to work effectively with veterinary customers and commercial sales teams 
• Strong interpersonal skills with a servant-leader mindset; self-motivated, adaptable, and comfortable managing multiple priorities 
• Ability to work independently while thriving in a collaborative, field-based and remote environment 
• Excellent oral, written, and presentation skills 
• Proficiency in Microsoft Office applications 
• Willingness and ability to travel up to 75% 
• This position will be based in the Kansas City Metropolitan area or the Florida Panhandle, near Pensacola, FL. Relocation assistance is available. 

1. Key Bullet Points for Specific Specialties: Cardiologists, Internal Medicine, Neurologists, Surgeons (small animal or equine), Sports Medicine/Rehabilitation, Anesthesiologist, Criticalists, Feline specialist, Behavioralist, Pharmacovigilance
   • Relevant experience in pharmacovigilance, drug safety, clinical research, or regulatory affairs within veterinary or pharmaceutical industries.
   • Familiarity with safety databases and pharmacovigilance reporting systems. 
   • Industry experience in post‑marketing surveillance and signal management. 
   • Prior experience supporting regulatory inspections or audits. 

Work Environment & Culture 

PBI-Gordon Companies offers a collaborative, employee-owned environment where accountability, partnership, and continuous improvement are valued. Team members are encouraged to contribute ideas, develop professionally, and grow their careers alongside the business. 

Equal Opportunity Employer 

PBI-Gordon Companies is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees.

If you're energized by clinical leadership in veterinary industry, shaping product strategy across commercialized portfolios and development pipelines, and partnering with cross-functional teams to drive impact, we'd love to hear from you. 

Apply today to join an employee-owned organization that invests deeply in its people and the future of companion animal health. 

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 10+ years of pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

POSITION SUMMARY:

Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs.

The Associate Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Associate Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership.

PRIMARY RESPONSIBILITIES:

• Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria  
• Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
• Provide protocol training and contribute to CRF design
• Ensure study manuals align with protocol and engage investigators in study design
• Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
• Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
• Serve as a clinical science representative on internal and external meetings 
• Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones
• in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Support meetings (advisory boards, etc) and deliver presentations
• Drive clinical research plans, including company and investigator-initiated studies
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives 
• Build relationships with KOLs, consortiums, and sites
• Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product 
• As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
• Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Ensure HIPAA/PHI compliance and maintain training requirements
• Perform other duties as assigned

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred
• 8+ years pharma/biotech industry experience in clinical development in oncology clinical trials
• Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection 
• Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols
• Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
• Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately

KNOWLEDGE, SKILLS, AND ABILITIES:

• Problem-solving skills and a fast learner
• Strong communication (oral and written) and attention to detail
• Ability to work independently and collaboratively
• Analytical and creative thinking
• Familiarity with Google and Microsoft suites
• Desire to work in a dynamic environment
• "Hands-on" leadership and a strong work ethic
• Ability to apply business knowledge, exercise judgment, and escalate issues appropriately
• Strong project management, organizational, and interpersonal skills
• Adaptability, initiative, and team-building skills
• Demonstrated success in working in a cross-functional environment
• Successful and superior influencing skills across all levels of the organization and external collaborators
• Conflict resolution and follow-through skills
• Results and goal-oriented
• Strategic and flexible thinking

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Office or home office setting with internet access
• Ability to use a computer, phone, and read materials 
• Flexibility to work with colleagues in a global setting
• Able to engage in work-related travel up to 25%

Brief team/department description:

Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a startup with intellectual rigor and creativity.

The Medical Affairs Manager – CORE (Cardiovascular, Obesity, Renal, Endocrinology) is a Hyderabad-based office position within the Medical Affairs Department, reporting to the Medical Lead for the CORE Franchise. The Medical Affairs Manager is responsible for supporting medical strategy to support the safe, effective, and evidence-based use of the company’s products. This role serves as a scientific expert and key liaison between internal teams and external stakeholders, including healthcare professionals (HCPs), key opinion leaders (KOLs), and academic institutions.

Principle Responsibilities:

• Support integrated Medical Affairs strategy aligned with brand objectives and overall corporate priorities.
• Provide scientific and clinical expertise across the full product lifecycle, including pre‑launch planning, launch execution, and post‑marketing support.
• Ensure all medical activities are conducted in accordance with applicable regulatory, legal, compliance, and ethical standards.
• Support and sustain strong relationships with key opinion leaders (KOLs) and other external scientific stakeholders.
• Plan and Support advisory boards, investigator meetings, and scientific symposia to advance scientific understanding and gather actionable insights.
• Support the development, review, and approval of medical materials (e.g., slide decks, FAQs, training content, scientific response documents) and participate in publication planning and execution (abstracts, posters, manuscripts) in close collaboration with Scientific Communications.
• Support stakeholder engagement and education planning in close collaboration with Medical Leads and Stakeholder Engagement Lead 
• Provide strategic medical input into congress planning, scientific content, and on‑site execution.
• Partner cross‑functionally with Clinical Development, Regulatory Affairs, Commercial, Market Access, and Pharmacovigilance to ensure aligned and effective execution of medical strategy.
• Support sales and internal teams through medical training, scientific education, and ongoing clinical guidance.
• Support real‑world evidence (RWE), investigator‑initiated studies (IIS), and post‑marketing studies in collaboration with Clinical Development as needed
• Collaborate with field medical team to analyze medical insights from external engagements to inform medical strategy and lifecycle planning
• Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing activities.
• Demonstrate adaptability, focus, and composure in fast-paced settings while operating with minimal direction.

Qualifications and Education Requirements

• Education:
• Advanced terminal degree (PharmD, PhD, MD, DO) OR other advanced medical degree (NP, PA, etc.) w/ 2+ years relevant therapeutic area clinical experience is required.
• Experience:
• 2-3 years relevant work exp (clinical, fellowship, or research experience) and/or related pharmaceutical industry work experience is required.
• Skills:
• Thorough knowledge or experience in cardiology and/or endocrinology is preferred
• Excellent interpersonal and communication skills with a passion for excellence
• Demonstrated ability to present effective and influential oral presentations
• Deep scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights
• Strong strategic and operational thinking skills, with the ability to manage effective networks
• Ability to work effectively in a time and independently
• Highly collaborative team player with experience working across cross-functional teams.
• Excellent organization skills and decision-making abilities. Skillfully plans, prioritizes, and executes multiple responsibilities and projects.
• Knowledge of relevant US healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends.
• Proficiency in digital tools.

Brief team/department description:

Azurity Pharmaceuticals is seeking an Associate, Drug Safety – Quality, Standards & Training to support drug safety quality systems, standards, audits, and training activities within the Global Drug Safety organization. This role is integral in maintaining inspection readiness, supporting compliance with global pharmacovigilance (PV) regulations, and enabling consistent execution of drug safety processes through effective documentation and training.

Reporting to the Manager, Drug Safety Compliance this associate-level role will work closely with Drug Safety Operations, Compliance, Quality, and cross-functional partners to support SOP management, training coordination, and continuous improvement initiatives.

Principle Responsibilities:

• Support the maintenance and administration of Drug Safety SOPs, work instructions, and standards, including document updates and version control.
• Support coordination of Drug Safety training programs, including onboarding and periodic refresher training.
• Track training completion, maintain training records, and support reporting of training compliance metrics.
• Support preparation for regulatory inspections internal and external audits related to pharmacovigilance.
• Assist with organization and maintenance of inspection-ready documentation and training records.
• Partner with Drug Safety Operations, Compliance, Quality, Regulatory Affairs, and Clinical teams to support consistent application of standards and training requirements.
• Serve as a point of coordination for quality- and training-related communications within Drug Safety.
• Support global Drug Safety initiatives that require standardized processes or training support.

Qualifications and Education Requirements

• 1–3 years of experience in pharmacovigilance, quality, compliance, training, or related roles within pharmaceutical, biotech, or regulated healthcare environments.
• Experience supporting quality systems, SOPs, and/or training coordination preferred
• Must have a clear understanding of pharmacovigilance and regulated quality environment.

Education

• Bachelor’s degree required in Life Sciences, Healthcare, Quality, Training, or related field.

Brief team/department description:

Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a startup with intellectual rigor and creativity.

The Medical Affairs Manager – Oncology is a Hyderabad-based office position within the Medical Affairs Department, reporting to the Medical Lead for the Oncology Franchise. The Medical Affairs Manager is responsible for leading and executing medical strategy to support the safe, effective, and evidence-based use of the company’s products. This role serves as a scientific expert and key liaison between internal teams and external stakeholders, including healthcare professionals (HCPs), key opinion leaders (KOLs), and academic institutions.

Principle Responsibilities:

• Develop and execute an integrated Medical Affairs strategy aligned with brand objectives and overall corporate priorities.
• Serve as a scientific and clinical expert across the full product lifecycle, including pre‑launch planning, launch execution, and post‑marketing support.
• Support and sustain strong relationships with key opinion leaders (KOLs) and other external scientific stakeholders.
• Plan and support advisory boards, investigator meetings, and scientific symposia to advance scientific understanding and gather actionable insights.
• Support the development, review, and approval of medical materials (e.g., slide decks, FAQs, training content) and support publication planning and execution (abstracts, posters, manuscripts) in close collaboration with Scientific Communications.
• Support stakeholder engagement and education planning in close collaboration with Medical Leads and Stakeholder Engagement Lead 
• Provide strategic medical input for conference planning, scientific content, and on‑site execution.
• Partner cross‑functionally with Clinical Development, Regulatory Affairs, Commercial, Market Access, and Pharmacovigilance to ensure aligned and effective execution of medical strategy.
• Support sales and internal teams through medical training, scientific education, and ongoing clinical guidance.
• Support real‑world evidence (RWE), investigator‑initiated studies (IIS), and post‑marketing studies in collaboration with Clinical Development as needed.
• Collaborate with field medical team to analyze medical insights from external engagements to inform medical strategy and lifecycle planning.
• Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing activities.
• Demonstrate adaptability, focus, and composure in fast-paced settings while operating with minimal direction.

Qualifications and Education Requirements

• Education:
  • Advanced terminal degree (PharmD, PhD, MD, DO) OR other advanced medical degree (NP, PA, etc.) w/ 1+ years relevant therapeutic area clinical experience is required.
  • Additional oncology-specific certifications (BCOP, AOCNP) highly desirable
• Experience:

• 2-3 years relevant work exp (clinical, fellowship, or research experience) and/or related pharmaceutical industry work experience is required.

• Skills:
  • Thorough knowledge or experience in Hematology/Oncology and/or Immunology is highly preferred
  • Excellent interpersonal and communication skills with a passion for excellence
  • Demonstrated ability to present effective and influential oral presentations
  • Deep scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights
  • Strong strategic and operational thinking skills, with the ability to manage effective networks
  • Ability to work effectively in a time and independently
  • Highly collaborative team player with experience working across cross-functional teams.
  • Excellent organization skills and decision-making abilities. Skillfully plans, prioritizes, and executes multiple responsibilities and projects.
  • Knowledge of relevant US healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends.

Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

#LI-Hybrid

Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

#LI-Hybrid
#LI-Full-time

Location: Boston, MA preferred

The salary range for the Director, Regulatory Strategy is expected to be between $210,000 and $235,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

Description of Role

Key Responsibilities

Strategic Leadership & Oversight 

• Develop and execute a comprehensive pharmacovigilance (PV) strategy aligned with corporate objectives and regulatory expectations.
• Lead safety governance and benefit-risk management for small molecule assets across development and post-marketing.
• Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.).
• Provide strategic safety input into clinical trial designs, protocols, and regulatory submissions.
• Establish and oversee PV partnerships, vendors, and external collaborations. 

Operational & Regulatory Compliance 

• Lead the safety surveillance and signal detection process, ensuring timely identification and mitigation of safety risks.
• Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts).
• Ensure robust case processing, signal evaluation, and risk management processes are in place.
• Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.). 

Cross-Functional Collaboration 

• Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making. 
• Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
• Support DSMBs, advisory boards, and investigator meetings with safety expertise. 

Team Leadership & Development 

• Build and lead a high-performing pharmacovigilance team, fostering a culture of scientific excellence and compliance.
• Provide mentorship and guidance to internal safety professionals. 

Compensation

The annual base salary range for this position is $350,000.00 to $380,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Vice President, Pharmacovigilance and Safety role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

Description of Role

We are seeking a Senior Scientist, Drug Safety (Pharmacovigilance) to support pharmacovigilance activities across Centessa’s clinical-stage development programs. Reporting to Centessa’s Head of Safety and Pharmacovigilance, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance, regulatory compliance, and program execution. The Senior Scientist will work closely with cross-functional partners and external vendors to ensure high-quality safety deliverables and maintain inspection-ready pharmacovigilance processes in a fast-paced, development-focused environment. 

Key Responsibilities

• Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs. 
• Lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions, including SUSARs, in alignment with global reporting requirements. 
• Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products. 
• Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings to cross-functional stakeholders. 
• Ensure the scientific integrity and quality of safety data through expert review of complex cases and mentorship of junior team members in case assessment and safety data interpretation.  
• Provide senior level scientific input into the preparation and review of DSURs, line listings, safety summaries, and safety-related sections of protocols, Investigator’s Brochures, and regulatory submissions. 
• Serve as the lead drug safety representative on cross-functional study teams, shaping safety strategy, influencing program decision-making, and advising on safety issue management.
• Maintain expert level knowledge of therapeutic areas and global drug safety regulations, guidelines, and evolving best practices (e.g., FDA, EMA, ICH, CIOMS), and apply this expertise to program decisions and safety governance. 
• Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.  
• Lead or contribute to complex, cross-functional safety projects, safety signal evaluations, and ad-hoc scientific analyses to support portfolio needs and organizational priorities. 

Qualifications

•  PharmD or PhD in scientific field
• 6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.  
• Prior experience facilitating in Safety Risk Assessment Meetings / Safety Review activities required. 
• Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP).
• Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred.
• Experience supporting clinical safety case processing and aggregate reporting.
• Strong analytical skills, attention to detail, and comfort working across multiple programs.
• Clear communicator who works effectively in small, cross-functional teams.
• CNS experience preferred. 

Compensation 

The annual base salary range for this job level is $145,000 to $190,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. 

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. 

Work Location 

Based in the US, with <10% travel.

POSITION: Full-Time, Exempt

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will provide vendor oversight and review of ICSR processing. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be the primary point of contact for quality oversight of the case processing vendor. They will work in close collaboration with PV physicians, PV scientists, and PV Excellence on operational safety and case quality issues The role will expand and evolve in line with Nuvalent’s expansion as we approach potential market authorization.

Responsibilities:

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities.
• Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans.
• Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training.
• Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• As needed. review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team.
• Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines.
• Serve as PV operations SME on safety reporting processes according to study protocol.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Serve as resource and contact for other functions within the company for pharmacovigilance
• operational activities.
• Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
• 8-10 years of experience in a biotech/pharma company.
• Direct experience managing relationships with service providers or external business partners
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements