Gehaltsübersicht für Clinical Trial Leader in Schweiz

Leading, planning, and delivering clinical trials Phase III in Oncology & / or Infectious disease , to ensure that studies are carried out according to protocols, SOPs, regulations and principles of GCP. From start-up to close out.Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are metManage operational aspects of projects including budgeting, study initiation and risk managementSelect and manage external vendors, such as CROs, central laboratories ...Ensure the delivery of the clinical study according to ICH GCPProvide operational & scientific input into Protocol synopsis, Study protocol and all other study related documentsParticipate to due diligence activitiesYour profileMSc or PhD degree in Biotechnology, Biology, Microbiology or Life Sciences related mattersMin of 8-10+ years' experience with proven track record of international clinical trials management (Phase III) in the Pharmaceutical Industry, biotech & / or CRO. Previous monitoring experience requiredSuccessful candidate must provide sound experience in Phase III clinical trial in Oncology (& / or Haematology & / or Infectious disease): mandatorySound expertise in the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.Excellent experience in management of CROs, vendors and consultantsProven track record in project management skills & team resources allocation and coordinationFluent in English Only the profiles matching the requirements will be considered (#PHASE III ONCOLOGY). Successful candidate must provide a FULL DOSSIER IN ENGLISH

The perfect candidate is someone with solid experience in global study management (on a leading level), ideally with experience of early phases, someone with effective leadership skills still able and happy to do operational work. The CRSL is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines Tasks & Responsibilities:Leads the cross-functional Study Management Team (SMT). In the SMT Leader (SMTL) role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality.Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking.Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle.Assures consistency and standards across a study or studies for all investigational sites and in line with project standards.  Must haves:Minimum 5 years in study management with extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studiesMinimum Bachelor (preference on Master) in Life Sciences Experience with global study managementExperience in pharma (preferred) or CRO Effective leadership skills, able to lead cross-functional teams across multiple time zonesExperience working in matrix environment and flat hierarchical team setting Nice to haves: Experience with early phases of clinical trialsNS & Infection & Oncology

 After the process rolls out, the single Business Process Leaders ensure implementation feedback is collected and escalate needs for changes to the global process. The team establishes with the affiliates and all its stakeholders quality and compliance with PV policies and processes and is driving process-level inspection readiness as the norm. Tasks & Responsibilities:Lead the affiliate working group involved for consultation on the processesIPV Business Process Management (IPV BPM) is the contact and collaboration point for the contractorIPV Business Process Management and EU Country Cluster Leads create an Affiliate Safety working group and the contractor would be coordinating this group representing IPV BPMWork closely with the affiliate working group member being part of the community of practice (CoP) for Clinical TrialsThe person should ideally have EU clinical trial and PV experience. They will be a part of relevant workstreams (ICSR process, ICSR systems, Reference Safety Information, Process) and lead the affiliate working group involved for consultation on the processesMust haves:Bachelor’s or Master’s degree in pharmacy or a science related field Minimum 7 to 10 years of experience within pharmacovigilance in industry with experience on the following: Headquarter Pharmacovigilance support to Investigational Clinical trials ; Headquarter Pharmacovigilance interactions with Local Safety Units ; Set-up of Global Clinical Trials in various geographies in the EEA; Knowledgeable of UK Exit situation for Pharmacovigilance and MHRA expectationsExperience working with safety in a clinical trial environment: ICSR reporting within the EEA Experience interacting from headquarter to local/affiliates Competencies /soft skills of the candidate:Ownership and accountabilityDecision makingStrong communication, influencing and negotiation skills.Strong interpersonal skills and partnering skills. Able to work efficiently and effectively in cross functional and matrix teams

The Position In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. You are a member of the Immunology leadership team, reporting to the pRED Global Head of Immunology. The focus of Immunology Early Development is to advance early clinical immunology development programs from preclinical studies through proof of concept and dose ranging phase 2 studies. This role is a key enabler in delivering on the clinical pipeline as well as the overall ambitions of the organization. Your main responsibilities You are responsible for the strategy of the immunology early clinical development portfolio and pipeline, and mentor, develop, guide, and serve as the leader for the clinical scientists, medical directors, and project team leaders. You work with the clinical phase project teams to ensure that clinical and clinical biomarker development plans, objectives, and deliverables are consistently accomplished on-time and on-target for assigned projects. You chair the Development Review Committee and provide key feedback and guidance on project strategy and plans and represent Immunology on the pRED Early Strategic Portfolio Committee. You serve as a core member of the pRED Immunology leadership team to build disease area strategy, discovery and development strategy, and operational excellence You explore and implement collaborations with industry and academia to increase understanding of disease biology, facilitate the prosecution of portfolio in early clinical development and build our clinical portfolio. You liaise with Roche Pharma Late Stage Development, Global Product Strategy, Regulatory and Clinical Operations, as well as other Roche Research and Discovery Units in discussions around disease strategy, discovery and development strategy, and operational excellence. Your profile With a MD or MD/PhD, you bring at least 5-10 years of experience in pharmaceutical research and development with a broad understanding of immune-mediated diseases, clinical trial design and methodology as well as biomarkers and diagnostics. You can ideally demonstrate a solid track record of successfully translating molecules from discovery into the clinical setting as well as an understanding of regulatory, payer, and commercial issues in the pharmaceutical industry. Your leadership has been demonstrated by an ability to work with peers across a matrix organization to deliver on common goals. You inspire people to think bold, to innovate, collaborate and create great outcomes that matter for our patients and customers. You are a leader who creates and communicates a clear strategic vision for the team and the organization. This includes monitoring and reassessing strategic priorities, articulating long-term opportunities/threats, evaluating options, and building clear paths to success You understand how to make difficult decisions and will be able to focus on key priorities and delivery toward goals and have the ability to empower teams, inspiring and creating a strong sense of team spirit in the organization. You help everyone on your team to build the skills and mindset they need to succeed. Our commitment Roche commits to recognising talent and aptitude. We prioritise encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career. We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more. Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events. We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.Über das Unternehmen:1201 F. Hoffmann-La Roche AG

Clinical Trials Lawyer (m;f;d)We are currently seeking Clinical Trial Lawyers (m/f/d) to work with various Axiom clients across all industries. Responsibilities: Provide advice and counsel on a range of legal matters pertaining to Clinical Trial Activities, Research & Development, and related activities. Draft, review and negotiate a variety of contracts including but not limited to: clinical trial agreements, clinical supply agreements, informed consent documentation with sponsors and CRO's. Negotiate with sophisticated counterparties. Provide practical legal advice and support on business matters in a fast-paced environment. Work with and advising business clients directly, as well as providing guidance and practical solutions. Minimum Qualifications: 3+ years practicing law in a law firm or in-house legal team. Experience at a pharmaceutical, biotechnology, medical device, or other life sciences company. Experience working with hospital systems and healthcare providers, and the nuances that exist as it pertains to clinical trials, is preferred. Strong understanding of the regulatory framework governing clinical trials, with a keen awareness of the differences in regulations across international jurisdictions. Preferred qualification for individual with multiple language skills including French, Italian, and/or Spanish. German is a MUST. Swiss qualification is a must. Broad-based knowledge of laws and regulations governing pharmaceutical activities with a focus on research & development and regulatory areas. Compensation, Benefits & Location: This role offers competitive compensation and a highly competitive benefits package in the alternative legal services marketplace, that includes Medical, dental, and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely, with the exception that some clients require on-site presence. Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today’s business landscape with best in breed alterative legal services. Axiom is a leader in diversity, inclusion, and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ+ Equality, earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axiom’s legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation. Learn more about working at Axiom. Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender reassignment, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment. Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form, please contact us at [email protected] and include “Applicant Accommodation” in the subject line. Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full privacy notice is available at https://www.axiomlaw.com/privacy-notice. Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. By submitting an application, you acknowledge that all information contained therein, and provided at any part of the application process, is correct and accurate to the best of your knowledge.

Company / Business Unit: Hamilton Medical AG more information Responsibilities: Hamilton Medical is seeking a highly skilled and experienced Project Leader to be an integral part of our team and play a pivotal role in leading the FDA approval process of our technology. The Project Leader at Hamilton Medical AG will be responsible for defining the plan and organize the project, including efficient management of resources and budget throughout the cycle of the medical device’s approval process starting from technical documents preparation and/or revision, including Clinical Trial Management up to securing FDA approval. You will work closely with cross-functional teams (CRO, R&D, Regulatory, Clinical Affairs and Clinical Research) to ensure our products meet global regulatory standards, enabling us to provide safe and effective solutions to healthcare providers and patients. Join our team in making a positive impact on healthcare worldwide. Your tasks, which you can perform office-based with a possibility of up to 60% home office after a 3-month probationary period, include the following: Develop project plan, set goals and budget as well as identify and manage resources. Monitor, track and report on progress and performance, including budget. Partner with external stakeholders to ensure robust collaboration, Clinical Research Organizations (CROs) and Key Opinion Leaders (KOLs). The initial focus of this role will be to ensure that technical files and clinical trial submission package are compiled and ready for 510K, de Novo, IDE and PMA submissions. Compliance Oversight: Maintain compliance with relevant regulations, standards, and guidelines throughout the development of clinical trial documentation and conduct of the clinical trial. Assist in preparing response to US regulatory authorities’ questions within assigned timelines. Describes and recommends strategies to senior management for earliest possible approvals of clinical trials applications in US in close collaborations with our Regulatory team. Ensures that submission packages are ready for clinical trial site ethics review board/FDA applications for investigational device trial(s). Ensures and contributes to the development of interim or final reports for trial site ethics boards/FDA review/submission, coordinates review processes. Will serve as main point of contact in case of involvement of a CRO for clinical trial management and will oversee document development for clinical trial submission, conduct and close out. Will be responsible for CRO selection, contract management and evaluation. Will be leading Project Team (P-Team): providing functional expertise and leading P-Team. defining and executing strategic implementation plans. interfacing with other workstreams and cross-functional stakeholders. Performs coordination and preparation of document packages for audits and inspections from all areas of company in close collaboration with regulatory team input to minimize potential for findings of non-compliance. Qualifications: Bachelor's degree in a relevant scientific or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or medical device development. Knowledge of FDA regulations (21 CFR 812, 814 and 820), ISO standards (ISO 13485: 2016, ISO 14971: 2019, ISO14155:2020), Regulation (EU) 2017/745. Proficiency in clinical trial management Class III or Class IIb - (EU) 2017/745 or IDE 21CFR 812. Minimum of eight years of Project planning, risk management, time management and other project management skills in the medical device industry . Ability to work collaboratively in a cross-functional team environment. Project management qualification (PMP), Certified associate in project management (CAPM), or equivalent experience as a project manager. Excellent communication skills. Problem-solving and leadership skills. Contract negotiation and conflict resolution experience Project planning, risk management, time management and other project management skills. Fluency in the English language; German and any other language is an advantage. Applications will be accepted until mid-February (15.02.2024). We look forward to receiving your documents! Are you interested? Then please apply online by clicking on the \"Apply\" button. If you have any questions, please do not hesitate to contact [email protected] with the following details: Reference: JR-2918-fjm/Contact: Julius Thomann Applications by post or e-mail can unfortunately not be considered. For more information on employment conditions at Hamilton, such as development opportunities and benefits, please visit our career page https://jobs.hamilton.ch/en/. «We drive innovation to improve people’s lives.» Improving and saving lives: that and nothing less is what Hamilton does - during and outside of pandemic times. As a leading and internationally active high-tech company in the life science sector, Hamilton drives state-of-the-art innovations in the development and production of intelligent respiratory equipment, laboratory robots, biopharma sensors, sample management solutions and other precision instruments. Our customers are hospitals, laboratories, research and industry around the globe. In addition, Hamilton has a strong presence in the growth markets of genetics, robotics, food and environment. The group currently employs around 3,000 people worldwide, more than half of them in Bonaduz and Domat/Ems in the beautiful Graubünden Rhine Valley. A further 15 sites are located in Zurich, Basel, Rapperswil, as well as in the United States, China, Romania and seven other countries in Europe. If you have any difficulties with the application or questions, please contact [email protected]. Applications by post or e-mail can unfortunately not be considered.Über das Unternehmen:Hamilton Medical AGWebsite:http://www.hamilton-medical.com

Job Description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. In this position you are working for a leading biopharmaceutical company with a diversified portfolio of prescription medicines and vaccines. The company has longstanding commitment to prevent and treat diseases and invests significantly in research and development to address unmet public health needs with innovative treatment options. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an addition to our Global Clinical Trial Operations Team and based in Lucerne, we are looking for a Clinical Trial Coordinator (CTC) (permanent full-time contract). As a Clinical Trial Coordinator you are responsible for comprehensive trial and site administration in Switzerland and in Austria. The person prepares, collates, distributes and archives clinical documents and ensures timely maintenance of tracking and reporting tools. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to ethics committees (ECs) and health authorities. The CTC is collaborating at local level closely with the country operations manager (COM), the project manager (CRM) and the clinical research associate (CRA). Furthermore, the CTC is managing payments according to contracts with clinical trial sites. The primary activities include but are not limited to: Trial and site administration: Track (e.g. essential documents) and report (e.g. Safety Reports) Ensure collation and distribution of study documents Update databases and trackers Document management: Prepare documents and correspondence Collate, distribute/ship, and archive clinical documents, e.g. eTMF Prepare Investigator trial file binders Regulatory & Site Start-Up responsibilities, collaborate with other country roles to: Provide to and collect from investigators forms/lists for site start-up and submissions Obtain, track and update study insurance certificates Support preparation of submission package for ECs and support health authority submissions. Budgeting, Agreement and Payments, collaborate with finance/budgeting representatives for: Calculate and execute payments to investigators Control trial site payments against budget, track payments from site set-up until close-out Ensure adherence to financial and compliance procedures Maintain tracking tools Qualifications: Bachelor’s or Master’s Degree in Life Science, Biology or equivalent or completed job training in office management/administration/finance Previous experience in clinical research or relevant healthcare experience Good understanding of clinical research guidelines and the local regulatory environment Fluent in German and English (verbal and written), Italian and/or French would be an asset Strong coordination, organizational, and time management skills High sense of accountability and urgency in order to properly prioritize and handle multiple tasks simultaneously in a changing environment Ability to work effectively in office but also remote/virtual environment with a wide range of people Positive mindset, growth mindset, work independently with assigned tasks Proactive attitude to solving problems/proposing solutions Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Interested in becoming part of a dynamic, developing team and contributing your know-how to an innovative environment that allows you to show initiative and that offers long-term perspectives? Please apply using the link to our career site! We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. THE COMPANY We are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. Our Company has had a presence in Switzerland since 1963 and employs around 1000 people at five sites in the cantons of Lucerne and Zurich. We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” since 2012 showing the company’s commitment to our employees and the community around us. The Switzerland Head Office is based in Lucerne's city center. Located in the heart of the city, employees work collaboratively across many departments including commercial, market access, medical affairs, clinical research, regulatory affairs, and policy & communications. The site also serves as our regional and local headquarters for our company’s Animal Health Division in Switzerland. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: On-Site Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Über das Unternehmen:1204 MSD Merck Sharp&Dohme AG

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Clinical Development Lead sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials. CDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy Serves as the clinical point of accountability for the Development Team and is responsible for the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s) Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) Key Responsibilities Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians May serve as CTP as necessary Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function Partners with Worldwide Patient Safety physicians in the ongoing review of safety data Serves as the (co-)leader of the cross-functional Clinical Development Team Provides clinical leadership and disease area expertise into integrated disease area strategies Partners closely with KOLs in specific indications Serves as Primary Clinical Representative in Regulatory interactions Evaluates strategic options against a given Target Product Profile (TPP) Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed Sets executional priorities and partners with CTP and CS to support executional delivery of studies Accountable for top line data with support of CTP, CS, and Statisticians Qualifications & Experience MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge At least 10 years of relevant experience Experience Requirements: CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes: Able to synthesize internal and external data to produce a clinical strategy Able to ensure that the clinical program will result in a viable registrational strategy Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues) Key Competency Requirements: CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s) External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials) Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables Travel Required Domestic and International travel may be required. The starting compensation for this job is a range from $308,000-354,000 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed. Final individual compensation will be decided based on demonstrated experience. For more on benefits, please visit our https://careers.bms.com/working-with-us. Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Über das Unternehmen:1525 JuN - Seattle Dexter

Based on protocol outlines, evaluate the feasibility and build a proposal for the supply of clinical trials in terms of packaging design, quality and regulatory compliance and supply chain.Manage the Contract Manufacturing Organization (CMO) performing the operational activities from packaging design to on site delivery, return, reconciliation and destructionSet-up the packaging, labeling, storage and management of IMP with the internal (data management, CTM,….) And external stakeholders (Contract Research Organization (CRO), CMO, Interactive Response Technology (IRT) vendors)Your profile:Experience of Clinical Trial Supplies management for phase I to phase III international clinical studies (double-blind, comparator and standard of care sourcing).Broad understanding and experience in setting up (specification definition) of the main tools related to Investigational Medicinal Products (IMP) management (simulation tools, IRT / Interactive Web Response System, ....)Broad understanding of regulatory and GMP requirements for IMP supply, IMP needs calculation , packaging design , IMP management and distributionExcellent project management skillsFluent in English

Leading, planning, and delivering clinical trials in Oncology & / or Infectious disease , to ensure that studies are carried out according to protocols, SOPs, regulations and principles of GCP.Manage operational aspects of projects including budgeting, study initiation and risk managementSelect and manage external vendors, such as CROs, central laboratories ...Ensure the delivery of the clinical study according to ICH GCPProvide operational & scientific input into Protocol synopsis, Study protocol and all other study related documentsParticipate to due diligence activitiesYour profile:MSc or PhD degree in Biotechnology, Biology, Microbiology or Life Sciences related mattersMin of 8+ years' experience with proven track record of international clinical trials management (phase I to III) in the Pharmaceutical Industry, biotech & / or CRO. Previous monitoring experience requiredSound expertise in the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.Excellent experience in management of CROs, vendors and consultantsProven track record in project management skills.Fluent in English