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Principal Medical Writer, Clinical Development Our client is a Biotech company with a strong pipeline, now wish to hire a Principal Medical Writer within their Clinical Development team, working closely with functional teams e.g. Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, etc. The successful candidate will author, review and manage clinical documents, e.g., clinical study protocols and/or amendments, investigator brochures, clinical study reports and clinical summaries, and regulatory development documents for FDA, EMA, MHRA, etc. This hire will be based in either Ireland or the UK; with flexibility to work remotely from their own home office, with occasional travel to their office. The ideal candidate will be an experienced Medical / Regulatory Writer, operating at Senior or Principal level,of clinical documents in clinical research, and writing clinical components in regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment. Responsibilities include: • Liaise with medical/clinical experts, statisticians, investigators, and other relevant stakeholders during document development., • Updating clinical and non-clinical regulatory documents throughout their lifecycle., • Supporting applications to authorities and drafting briefing packages., • Overseeing publications of key guidelines within relevant diseases and support internal training., • Draft literature reviews, abstracts, posters, slide decks, working from various data sources including clinical study reports, protocols, etc., • Coordinate trial team participation in the preparation of such documents, including facilitating meetings, developing and managing timelines, document review, and decisions., • Supporting development of communication material and ensuring company messaging is conveyed in a consistent scientific manner across documents., • Generating templates and ensuring alignment across documents., • Support the development of communication material. Qualification and experience requirements include: • BSc in Life Sciences. Advanced Qualifications preferred i.e. PhD and Post Doctorate work., • 5+ years Pharma / Biotech industry experience, 2 years of which in Regulatory Medical Writer role or similar., • In-depth of knowledge writing or editing clinical trial documents, e.g., Protocols, IBs, CSRs and clinical summaries to ICH GCP and regulatory requirements, • Experience in preparation of clinical components in regulatory filings (NDA, BLA, MAA) is preferred., • Strong analytical skills including good understanding of common statistical methods used in clinical trials and interpretation of their results., • High quality standards and is committed to meet deadlines., • Excellent written and oral communication skill within medical/science area., • Solid ability to perform background literature research., • Excellent English (written and spoken)., • Excellent attention to detail. For further details, please contact Larry on +353 1 – 2302400 / The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. Follow us on Twitter, Facebook and LinkedIn

• Job Title: Lead Clinical Research Associate, • Location: Remote in UK, • Salary: £56,000 - £63,000 (DOE), • Additional Benefits: Car allowance (or company car) and bonus, • Sign-on Bonus: Potential sign-on bonus for qualified candidates, • Company: Global CRO RBW Consulting is thrilled to present an exciting opportunity on behalf of one of our esteemed clients. As one of the few rapidly growing Contract Research Organizations (CROs) for UK studies, our client is expanding their site management team with multiple hires this year. They are involved in a diverse range of studies, including cutting-edge research in advanced therapies such as CAR-T. Join a highly experienced team dedicated to excellence in clinical research. In this role, you will benefit from a supportive management team committed to your professional growth. They provide clear guidance on the skills needed for advancement and offer fluid career development opportunities across various departments. This company prioritizes quality over metrics and is currently generating significant excitement within their UK team. Key accountabilities • Autonomy of investigator sites with full responsibility for the successful management of sites through study life cycle (start-up to close-out);, • Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas;, • Prepare accordingly and attend investigator meetings, coordinating timely delivery and subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues;, • Perform source document verification and case report form review;, • Perform regulatory document review;, • Conduct study drug inventory;, • Perform adverse event and serious adverse event reporting and follow-up; and, • Assess patient recruitment and retention. Qualifications • Bachelor of Science in health-related field (or equivalent), • Proven CRA experience; 5 years minimum Why Join? • Supportive Environment: Build strong relationships with a transparent management team focused on your development., • Innovative Approach: Work with a company that embraces a 360 monitoring approach and leverages AI to enhance efficiency and save time., • Results-Driven KPIs: Our client's key performance indicators are centered around tangible study outcomes, such as patient recruitment, visit reports, and resolving site issues., • Administrative Support: Dedicated admin staff to help with site management tasks, helping to maintain a balanced workload., • Training: Extensive training and buddy system in place., • Career Growth: promotion opportunities up to 4 times a year., • Therapy Areas: Access to mixed therapy areas, including advanced therapies like CAR-T. To apply Please click ‘apply’ or contact Joe Pearce for any further information About RBW Consulting RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain. We are an equal opportunities Recruitment Business and Agency RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

Job Title: QA Manager (Consultant) – GCP Compliance (Biotech / Phase II) About the Company We are a growing biotechnology company advancing Phase II clinical programs. As we expand our clinical operations and global trial footprint, we are strengthening our Quality Management System and GCP oversight. We are seeking an experienced QA Manager (Consultant) who brings strong GCP quality expertise and hands-on experience supporting teams through MHRA and FDA regulatory expectations. This is a contract / part-time / fractional role with flexible engagement structure. Role Overview The QA Manager (Consultant) will lead GCP quality assurance activities across ongoing clinical trials, vendors, and documentation systems. The ideal candidate brings practical, scalable approaches to quality in a mid-stage biotech environment, and can both advise strategically and execute hands-on quality tasks. Key Responsibilities • Oversee and maintain GCP components of the Quality Management System (QMS) to support Phase II clinical activities., • Perform clinical site audits, vendor/CRO audits, and internal process audits., • Ensure ongoing GCP compliance throughout clinical trial execution., • Serve as QA representative for inspection readiness and regulatory interactions, including MHRA and FDA expectations., • Review and approve clinical documentation, including protocols, Investigator Brochures, monitoring plans, TMF records, deviations, and CAPAs., • Support development and maintenance of SOPs and training programs for clinical and cross-functional teams., • Provide coaching and guidance to Clinical Operations, Medical, and outsourced partners., • Support preparation, response, and CAPA follow-up for inspections and audits. Qualifications Required • 7+ years of Quality Assurance experience in biotechnology, pharma, or CRO environment., • Strong GCP quality background supporting Phase I–III clinical trials., • Demonstrated experience preparing for and supporting MHRA and FDA inspections., • Experience conducting clinical site audits and vendor audits., • Ability to evaluate and improve QMS processes in a growing organization., • Excellent communication, collaboration, and documentation skills. Preferred • Experience with EU trials or global Quality oversight., • Familiarity with TMF structure and metrics. Engagement Details • Consulting / Contract / Fractional role, • Estimated workload: 0.4 - 0.5 FTE, depending on stage and needs, • Remote or hybrid, with occasional on-site meetings or audits as required, • Contract duration: 12 months with potential extension

Medical Regulatory Writing Manager Our client is a Biotech company with a strong pipeline, now wish to hire a Regulatory Medical Writing Manager working closely with functional teams e.g. Regulatory Affairs, Medical Writing, Clinical Operations, Medical Affairs, etc. The successful candidate will author, review and manage clinical documents, e.g., clinical study protocols and/or amendments, investigator brochures, clinical study reports and clinical summaries, and regulatory development documents for FDA, EMA, MHRA, etc. This hire will be work remotely from their own home office in the UK (must be resident there, with work authorisation), with occasional travel to their HQ office. The ideal candidate will be experienced in preparing, coordinating and managing Regulatory Submissions of clinical documents and writing clinical components for regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment. Requirements include: • BSc in Life Sciences. Advanced Qualifications preferred i.e. PhD and Post Doctorate work., • 8+ years Pharma / Biotech industry experience, 3 years of authoring, writing or editing of clinical documents for regulatory filings / submissions i.e. NDA, BLA, MAA within Pharma / Biotech environment., • In-depth of knowledge writing or editing clinical trial documents, e.g., Protocols, IBs, CSRs and clinical summaries to ICH GCP and regulatory requirements., • Strong analytical skills including good understanding of common statistical methods used in clinical trials and interpretation of their results., • High quality standards and is committed to meet deadlines., • Excellent written and oral communication skill within medical/science area., • Solid ability to perform background literature research., • Excellent English (written and spoken)., • Excellent attention to detail. For further details, please contact Larry on +353 1 – 2302400 / The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. Follow us on Twitter, Facebook and LinkedIn

About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: • Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met, • Initiates and builds solid professional relationships with key opinion leaders and clinical site staff, • Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time, • Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data, • Proactive identification and management of study related risks, • Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements, • Responsible for reviewing and managing study related plans, processes including, • Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring, • Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met, • Reviews and approves essential document packages to enable timely site activations, • Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report, • Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates, • Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary, • Responsible for oversight on the maintenance of the TMF and completeness at the end of the study, • Perform periodic QC of the TMF, • Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs, • Ensures the study is “inspection ready” always, • Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project, • All other duties as assigned Experience, Education and Specialized Knowledge and Skills: • Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred, • 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization, • Prior phase II and III experience required, • A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, • Experience with budget forecasting and management, • Experience with clinical studies in oncology, • Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%), • Proven proficiency in overseeing large complex studies being managed in house and by a CRO, • Demonstrated ability to lead teams and work in a fast-paced team environment, • Experienced and enjoys building relationships with KOLs and site personnel, • Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues, • Demonstrated ability to build and deliver on patient enrollment strategies, • Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives, • Demonstrated ability to comprehend complex scientific concepts and data, • Proficient in reviewing and assessing clinical data, • Possesses excellent planning, time management & coordination skills, • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs, • Experience in working in a small organization, • Excellent written and oral communication skills Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Clinical Operations Leader Qualifications: • Strong personality with excellent ability to navigate cross-functional relationships., • Experience in biotech or pharmaceutical environments, leading clinical trials end-to-end., • Proven capability managing large, complex budgets., • Excellent verbal and written communication with internal and external stakeholders. Responsibilities: • Lead clinical operations teams and contribute to strategy and execution of global clinical programs., • Oversee planning, budgeting, and management of clinical studies across multiple regions., • Coordinate with internal teams and external service providers to ensure timely, cost-effective project delivery., • Develop and review clinical trial protocols and study plans., • Support scenario planning, risk assessments, and operational best practices to improve efficiency., • Manage resource strategies for global drug development initiatives., • Maintain strong relationships with pharmaceutical partners, vendors, and suppliers., • Ensure clear communication and information sharing across projects., • Participate in regulatory submissions, meetings, and due diligence for in-licensing opportunities., • Mentor teams, conduct performance reviews, and support SOP development for clinical trials., • Represent the company at Investigator Meetings and other external events. Benefits: • Salary: £120,000 - £140,000 + benefits (DOE)

• Job Title: Senior CRA / Senior CRA II, • Location: Remote in UK, • Salary: £53,000 - £59,000 (DOE), • Additional Benefits: Car allowance (or company car) and bonus, • Sign-on Bonus: Potential sign-on bonus for qualified candidates, • Company: Global CRO RBW Consulting is thrilled to present an exciting opportunity on behalf of one of our esteemed clients. As one of the few rapidly growing Contract Research Organizations (CROs) for UK studies, our client is expanding their site management team with multiple hires this year. They are involved in a diverse range of studies, including cutting-edge research in advanced therapies such as CAR-T. Join a highly experienced team dedicated to excellence in clinical research. In this role, you will benefit from a supportive management team committed to your professional growth. They provide clear guidance on the skills needed for advancement and offer fluid career development opportunities across various departments. This company prioritizes quality over metrics and is currently generating significant excitement within their UK team. Key accountabilities • Autonomy of investigator sites with full responsibility for the successful management of sites through study life cycle (start-up to close-out);, • Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas;, • Prepare accordingly and attend investigator meetings, coordinating timely delivery and subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues;, • Perform source document verification and case report form review;, • Perform regulatory document review;, • Conduct study drug inventory;, • Perform adverse event and serious adverse event reporting and follow-up; and, • Assess patient recruitment and retention. Qualifications • Bachelor of Science in health-related field (or equivalent), • Proven CRA experience; 3 years minimum To apply Please click ‘apply’ or contact Joe Pearce for any further information About RBW Consulting RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain. We are an equal opportunities Recruitment Business and Agency RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

Principal Project Lead Biostatistician – Leading CRO – Homebased – UK / Europe We have recently partnered with an award winning CRO, who are looking for an experienced Principal Statistician, to join their successful study delivery team, any area of specialism considered How you will be a success The Principal Biostatistician will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies. Regulatory interaction experience also preferred. Desirable Experience • Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design, • Review project database structures, edit checks and data management coding conventions, • Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports, • Statistical analysis, Interpretation of data and reporting of results, • Writing of the statistical methods sections of integrated study reports., • Reviews draft integrated study reports., • Supports responses to regulatory questions on the design of the program, and any labelling claims following submission, • Participates in presentations at client and investigator meetings, • Preparation of biostatistics input to company research proposals and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. Key Qualifications and Skills • M.S. or Ph.D. degree in statistics, biostatistics, or related field., • Experience in statistics, biostatistics or related field, • Respiratory experience highly desired, • Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact., • Ongoing coaching and mentorship of team members., • Knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must. What you get in return Ongoing development is vital, and as a Principal Biostatistician you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. In comparison with their competitor’s and pharmaceutical companies, they provide more flexible working platforms for coaching and educating newcomers to be highly respected professionals in our industry. They also provide successful candidates with an excellent employment package and benefits adapted to the current job market. The company like to look at themselves more like an extended family with consideration of staff as individuals allowing a work-life balance. What to do next: If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.

Clinical Trial Manager – UK | Advanced Clinical (FSP Model) Oncology focused Advanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience. Responsibilities include: • Managing external vendors and CROs, • Preparing key study documents, including Monitoring Manuals, Study Operations Manuals, SDV Plans, and Laboratory Manuals, • Designing and coordinating study materials such as CRFs, patient diaries, source documents, and participation cards, • Assisting with protocol development and study reports, • Overseeing monitoring activities to ensure compliance with GCP, SOPs, and study protocols, • Providing direction and support to CRAs, • Tracking patient enrollment, conducting site qualification/initiation/close-out activities, and supporting data management coordination, • Managing study supplies and negotiating vendor contracts, • Reviewing ICFs, CRFs, and study-related materials, • Planning and participating in investigator meetings, • Supporting the data query process, • Ensuring regulatory compliance and maintaining an up-to-date Trial Master File Essential Requirements: • BA/BS degree or nursing qualification (science preferred), • Minimum 5 years' experience in clinical studies, including at least 1 year of site management, • Previous monitoring or study coordination experience preferred, • Strong knowledge of GCP and SOPs, • Understanding of clinical study phases, • Ability to work independently and within cross-functional teams, • Advanced proficiency in Word, Excel, and PowerPoint, • Experience with electronic systems such as TMF, CTMS, Veeva Vault, Smartsheet, and SharePoint, • Strong communication skills, • Willingness to travel 10–20% To express interest or learn more about this opportunity, please get in touch. Advanced Clinical offers a collaborative environment where your contributions directly support the success of innovative clinical research.

Investigator – Clinical Trials Role Summary: The Investigator leads and oversees clinical trials at their site, ensuring participant safety, regulatory compliance, and high-quality data collection. They provide medical expertise, guide study teams, and communicate effectively with sponsors, study directors, and site staff. Key Responsibilities: • Provide overall medical direction and review study protocols in line with GCP and investigational plans., • Ensure participant safety, rights, and confidentiality throughout the trial., • Oversee clinical procedures, assessments, and administration of investigational products., • Ensure accurate, complete, and timely data collection; maintain proper documentation and regulatory compliance., • Collaborate with clinical operations, research staff, sponsors, and IRBs, including reporting adverse events and protocol deviations., • Review and monitor protocol adherence, study materials, and investigational product use., • Facilitate monitoring, audits, and inspections by sponsors and regulatory authorities., • Inform participants and IRBs appropriately if the trial is terminated or suspended. Required Skills & Abilities: • Strong knowledge of GCP, regulatory requirements, and biomedical research ethics., • Excellent communication, collaboration, and critical thinking skills., • Attention to detail and dynamic problem-solving capabilities., • Commercial understanding of business operations., • Willingness to travel as required (up to 10%). Education & Experience: • Medical degree recognised by the GMC with an active GMC license., • GCP training and certification., • Board certification or eligibility in a specialty relevant to the research conducted at the site.

Precision for Medicine is hiring a Medical Director/Senior Medical Director – Oncology to join our global team! candidates can work remotely in any of the following locations: UK, Poland, Hungary, Romania, Serbia or Slovakia. Position Summary The Medical Director serves as the project physician and provides medical and scientific expertise to project teams. The Medical Director’s primary focus of work will be to ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety. This position also participates in the strategic planning and execution of critical development programs for a variety of clients in Oncology/Haematology contributes to the development of Precision’s Medical team and supports Business Development activities. Essential functions of the job include but are not limited to: • Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement., • Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings., • Write or edit scientific content of deliverables within budget and timelines., • Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy., • Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts)., • Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications., • Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed., • Serve as a medical resource for study sites, the project team and clients., • Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions., • Assume responsibility for medical and safety monitoring on assigned projects., • Participate in feasibility discussions relating to specific project proposals., • Develop training modules and provide training concentrating on disease states., • Participate in process improvement activities., • Collaborate with Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally. Qualifications Minimum Required: • MD, DO, MBBS, or equivalent medical qualifications., • 5+ years of Oncology clinical experience., • Ability to strategically analyze oncology clinical trial protocols., • Availability for domestic and international travel including overnight stays (approximate 30% travel requirement). Preferred • Experience working as a Medical Director for a CRO or Pharmaceutical company., • Oncology Fellowship or equivalent., • Maintains current scientific and medical knowledge base. Skills/Competencies • Ability to deliver on commitments; understands the service culture., • Strategic thinker who can build strategic drug development solutions associated with novel development programs, study designs, and patient populations., • Demonstrates a high degree of professionalism, as evidenced by punctuality, positive interactions with customers and teammates, including good interpersonal skills., • Communicate effectively in the English language both verbally and in a written form., • Conduct formal presentations to a wide variety of audiences including colleagues., • Strong visual and presentation skills., • Ability to work effectively in a fast-pacing team setting, with minimal supervision., • Proven efficiency in working remotely. Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. Any data provided as a part of this application will be stored in accordance with our ___ For CA applicants, please also refer to our ___. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Lead Physician – London Overview An exciting opportunity is available for a senior medical professional to take a leadership role in the delivery of clinical trials involving various Therapy area's. The position is ideal for someone with prior Principal Investigator experience and a strong interest in mental health innovation. You’ll be working across dynamic, multi-disciplinary teams, guiding trials from early phases through to completion, while maintaining the highest standards in clinical care, compliance, and operational delivery. Role Focus The successful candidate will be responsible for safeguarding participant wellbeing, ensuring trial integrity, and upholding compliance with all relevant clinical regulations and best practices. In this role, you’ll help shape the future of research in an evolving area of mental health treatment. Key Duties and Responsibilities • Take full responsibility for the medical conduct of clinical studies as the lead investigator, • Ensure all research activities comply with Good Clinical Practice (GCP) guidelines and regulatory standards, • Conduct eligibility assessments, safety evaluations, and clinical reviews throughout the study lifecycle, • Make appropriate clinical decisions regarding patient inclusion, dosing readiness, and follow-up care, • Supervise the reporting of any adverse or serious adverse events and ensure timely communication with relevant oversight bodies, • Mentor and support clinical teams involved in research delivery, providing ongoing guidance and medical input, • Collaborate effectively with operational teams, sponsors, and external research partners, • Review and sign off on essential clinical documentation, including source notes and trial case report forms, • Oversee the use, control, and accountability of investigational products and other study-related medications, • Monitor the collection and quality of structured clinical assessments and psychiatric rating scales, • Keep up to date with developments in psychedelic research and relevant clinical guidelines Skills and Experience Required • Medical qualification with active professional registration and licence to practise, • Specialist accreditation or membership (e.g., psychiatry, internal medicine, or similar), • Prior experience acting as Principal Investigator on clinical trials, • Solid understanding of regulatory frameworks including GCP, FDA, EMA, and other global standards, • Previous involvement in psychiatric or CNS-focused studies preferred, • Confident in managing clinical risk and making sound medical decisions, • Proficient in clinical assessments and familiar with tools such as MINI, CAPS-5, or C-SSRS, • Strong communicator, capable of working with diverse teams and external stakeholders, • Comfortable with oversight of investigational products and protocol compliance

Company Overview Milestone Technologies is a global IT managed services firm that partners with organizations to scale their technology, infrastructure and services to drive specific business outcomes such as digital transformation, innovation, and operational agility. Milestone is focused on building an employee-first, performance-based culture and for over 25 years, we have a demonstrated history of supporting category-defining enterprise clients that are growing ahead of the market. The company specializes in providing solutions across Application Services and Consulting, Digital Product Engineering, Digital Workplace Services, Private Cloud Services, AI/Automation, and ServiceNow. Milestone culture is built to provide a collaborative, inclusive environment that supports employees and empowers them to reach their full potential. Our seasoned professionals deliver services based on Milestone’s best practices and service delivery framework. By leveraging our vast knowledge base to execute initiatives, we deliver both short-term and long-term value to our clients and apply continuous service improvement to deliver transformational benefits to IT. With Intelligent Automation, Milestone helps businesses further accelerate their IT transformation. The result is a sharper focus on business objectives and a dramatic improvement in employee productivity. Through our key technology partnerships and our people-first approach, Milestone continues to deliver industry-leading innovation to our clients. With more than 3,000 employees serving over 200 companies worldwide, we are following our mission of revolutionizing the way IT is deployed. Job Overview Job Description We are looking for a highly skilled Technical Operations Lead to join our Cybersecurity Investigations team. This role is pivotal in managing technical operations and ensuring the integrity, confidentiality, and availability of our digital assets through proactive and reactive cybersecurity measures. The successful candidate will lead a team of skilled professionals and collaborate with our global leads and client partners to successfully deliver the UK Timezone of a global service team. This role is 100% remote, based in the U.K. with flexible hours required to support global operations. The role reports into our US-based Service Delivery team and works closely with clients based in the U.K. and and US. Key Responsibilities • Provide leadership by mentoring and developing a team of cybersecurity professionals, focusing on building a collaborative, innovative, and high-performing work environment through effective management of performance, recruitment, and ongoing training initiatives., • Actively build and develop the capabilities of team members through the design and execution of training programs, and by dedicating daily time to quality assurance activities such as reviewing individual ticket handling, providing constructive feedback, and identifying skill gaps for targeted development., • Oversee all daily technical operations within the Cybersecurity Investigations team by ensuring established client security protocols are rigorously followed., • Manage and coordinate all aspects of incident response and forensic investigations through following the client parameters while also proactively making suggestions for process improvement., • Manage long-term initiatives for the global team to include global alignment projects, development of processes and standards, change management of processes, reporting and other requests by clients., • Stay abreast of new investigation types and ensure the team has all applicable investigation skills to perform at an adequate level., • Serve as the primary technical liaison between the client team and the UK Based Cybersecurity Investigations team and other departments, facilitating communication and cooperation, preparing detailed reports and presentations on security trends, incident status, and risk mitigation for senior management., • Monitor scheduling to meet baseline standards, handle attendance, timecard tracking and ensure that team members are following applicable laws and regulations in their country., • Bachelor’s degree in Computer Science, Information Technology, Cybersecurity, or a related field., • Certification in cybersecurity (e.g., CISSP, CISM, or equivalent)., • Minimum of 10 years of experience in cybersecurity operations or a similar role (hands-on technical experience)., • Minimum of 5 years of active investigator experience in an IR team, preferably in global enterprise environment, • Proven experience leading and managing technical teams., • Strong understanding of cybersecurity frameworks and standards (e.g., NIST, ISO/IEC 27001, IAM)., • Proficiency with cybersecurity tools and platforms (e.g., SIEM, SOAR, SAS, Sandboxes, EDR solutions and cloud technologies)., • Working of knowledge of access control principles, cloud technologies (CNAPP, CSPM), data retention, and encryption methodologies., • Excellent problem-solving, investigative mindset, and communication skills., • Experience presenting at a program level for clients and/or cross functional partners, • Demonstrated ability to work under pressure, • Preferred, active participation in cybersecurity communities or forums., • Preferred, knowledge of programming languages (including database queries), • Preferred, forensic investigation experience Compensation Estimated Pay Range: Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and location. Our Commitment to Diversity & Inclusion At Milestone we strive to create a workplace that reflects the communities we serve and work with, where we all feel empowered to bring our full, authentic selves to work. We know creating a diverse and inclusive culture that champions equity and belonging is not only the right thing to do for our employees but is also critical to our continued success. Milestone Technologies provides equal employment opportunity for all applicants and employees. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, gender, gender identity, marital status, age, disability, veteran status, sexual orientation, national origin, or any other category protected by applicable federal and state law, or local ordinance. Milestone also makes reasonable accommodations for disabled applicants and employees. We welcome the unique background, culture, experiences, knowledge, innovation, self-expression and perspectives you can bring to our global community. Our recruitment team is looking forward to meeting you.

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