Lead and manage global regulatory activities for Summit’s investigational therapy, ensuring compliance with FDA and international authorities while driving clinical development timelines.
Compensation
$168,000—$198,000 USD
Responsibilities
Provide scientific and regulatory guidance to project teams at the clinical study level
Assess, develop, and implement global regulatory strategies for ivonescimab
Independently manage regulatory activities including CTA, IND, BLA, and MAA submissions
Review and approve investigator document packages and FDA submissions
Coordinate written responses to agency queries and track regulatory commitments
Requirements
BA/BS in Biotechnology, Biological Sciences, or related field
Graduate-level degree such as MS, PhD, or PharmD
Nice to have: knowledge of Chinese
Nice to have: experience with ex-US CTAs
Nice to have: experience with ex-US health authority interactions
Contribute to the development and delivery of consulting projects, taking ownership of project workstreams and client deliverables, while guiding team members in supporting pharmaceutical companies to develop successful market access strategies.
Compensation
The potential base pay range for this role, when annualized, is €55,800.00 - €83,800.00.
Responsibilities
Lead the day-to-day delivery of Pricing & Market Access projects and workstreams, ensuring high-quality outputs, adherence to timelines and alignment with client objectives
Lead the development of strategic market access recommendations, including product positioning, value proposition, pricing, reimbursement and negotiation strategies
Oversee qualitative and quantitative analyses and lead the development of Pricing & Reimbursement Dossiers, Value Dossiers and other value communication materials at national and regional level
Manage Payer & KOL consultations, including the preparation and moderation of Advisory Boards, Mock negotiation and interviews
Manage the preparation, execution and follow up of client workshops
Requirements
A second degree / specialization in Market Access, Health Economics or relevant fields
Senior Clinical Research Associate responsible for site monitoring and management across the full study lifecycle in France.
Locations (2)
Paris, Île-de-France, France
Montpellier, Occitanie, France
Responsibilities
Manage clinical trial sites across the full study lifecycle, including site qualification, initiation, routine monitoring and close-out visits.
Build strong relationships with investigators and site teams, acting as a key point of contact throughout the study.
Ensure patient safety, protocol compliance and adherence to informed consent and applicable regulatory requirements.
Review source documentation and clinical data to ensure accuracy, completeness and data integrity.
Proactively identify site-level risks and issues, drive timely resolution and maintain inspection and audit readiness.
Requirements
University or college degree, preferably in life sciences, healthcare or another relevant discipline, or equivalent relevant clinical research experience.
Provide analytical support to the client’s drug substance manufacturing and method development services, involving project analysis, method development, forced degradation studies and proof of concept method validation.
Responsibilities
Provide analytical support for Eurofins’ drug substance manufacturing and method development projects
Perform project analysis, method development activities, forced degradation studies, proof of concept validation work, and data interpretation
Contribute to the authoring and review of key analytical documentation
Work independently and collaboratively within a multidisciplinary team
Apply strong technical expertise and problem-solving skills to investigate challenges
Lead and oversee all clinical data management activities across multiple therapeutic areas, ensuring compliance with regulatory standards and driving process improvements.
Compensation
Salary Range: $212,000.00 to $276,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience.
Responsibilities
Provide leadership and oversight for the execution of clinical data management activities across multiple therapeutic areas and molecules.
Lead CDM activities at the project or study level, as needed.
Manage a team of Managers and Clinical Data Associates, ensuring effective support for complex data management needs.
Direct and guide team through DM lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
Requirements
BA/BS or higher in math, science, or health-related field
Nice to have: prior experience supporting regulatory submissions
Nice to have: preparing for and supporting regulatory inspections and audits
The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s).
Responsibilities
Performing selection, initiation, interim monitoring and closeout visits (remote and onsite)
Driving performance at the sites and ensuring timely resolution of study-related issues
Training, supporting and advising Investigators and site staff in study related matters
Developing recruitment plans and managing enrollment to meet milestones
Preparing and finalizing monitoring visit reports in CTMS
Requirements
Bachelor's degree in related discipline, preferably in life science, or equivalent qualification
Nice to have: experience in rare medical conditions
Providing scientific and statistical leadership to support initiatives on designing innovative clinical trials and to evaluate, develop and deploy advanced and novel statistical/analytical modeling and simulations to drive innovation in Clinical Development.
Responsibilities
Actively supports in the evaluation, introduction, development and education of novel statistical and/or machine learning/deep learning approaches.
Investigating/evaluating complex innovative designs and analysis options using scientific computing, modeling and simulations.
Seeks to acquire new knowledge in advanced and emerging statistical methods (e.g. Adaptive designs, Bayesian methods, synthetic control, predictive modeling etc.).
Creates, invents, and implements new or better approaches, alternatives, and breakthrough ideas in modeling and simulations.
Applies statistical knowledge to solve real-world problems.
Requirements
PhD in Statistics
PhD in Biostatistics
highly related field PhD
Nice to have: experience in pharmaceutical de development
A unique opportunity to play a key role in the research and development organization, allowing for hands-on scientific responsibility of clinical trial execution and delivery in support of a Phase 3 pivotal study slated for NDA submission.
Compensation
$159,000—$195,000 USD
Responsibilities
Support the Medical Directors for one or more Phase I–III clinical studies
Lead studies across the full trial lifecycle, from start-up through database lock and reporting
Provide scientific input to the efficacy and safety endpoint objectives of clinical trials
Identify and provide solutions to data trends, inconsistencies, and potential issues; partnering with Data Management, Biostatistics, and Safety
Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
Medical Writer to support the development of clinical trial documents and regulatory submissions, focusing on scientific writing in accordance with regulatory guidelines.
Compensation
$105-130k
Responsibilities
Support the development of clinical documents that are compliant with regulatory guidelines, including preparation of redlined versions and summary of changes documents as required.
Perform comprehensive quality control (QC) reviews of deliverables, including editorial, formatting, verification against source documents, and cross-referencing data consistency as needed.
Develop and maintain document components such as lists of abbreviations and references and appendices, and ensure consistent formatting and style throughout documents.
Format documents (e.g., tables, figures, cross-reference insertions).
Effectively incorporate reviewer feedback and lead comment adjudication meetings.
Requirements
Bachelor’s degree in life sciences, scientific communications, or a related field
Lead regulatory review and risk assessment of promotional materials for pharmaceutical products in the US, ensuring compliance with FDA promotional regulations.
Compensation
The annual base pay for this position ranges from $150,202 - $225,303 USD Annual. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Lead review and adjudication of promotional materials through AZAP
Represent AstraZeneca to regulatory authorities
Provide regulatory guidance to cross-functional partners
Conduct reviews within established timelines
Assist in innovative regulatory strategy development
Requirements
Bachelor's Degree in pharmacy, pharmacology, life science, related science field
Associate Director, Regulatory AffairsNewSummit Therapeutics · Remote, US
Associate Director, Clinical ScientistKailera Therapeutics, Inc. · Waltham, US
Medical WriterDBV Technologies · Warren, US
Associate Director, Promotional Regulatory Affairs (BBU)AstraZeneca · Gaithersburg, US