Senior Medical Director, Clinical Devlopment & Medical Affairs
Title: Senior Medical Director of Clinical Development & Medical Affairs Location: New Jersey, USA OR Remote (Continental USA only) A mid-size pharmaceutical company is hiring a Senior Medical Director to join the Global Clinical Development and Medical Affairs team. As Senior Medical Director, you will have oversight of a multi-disciplinary team and will lead the strategic planning and execution of a Clinical Development program, as well as the development of Medical Affairs strategy and publications planning for global product launches. Responsibilities: Oversee clinical trial design and execution (especially Phase 3 and Phase 4 studies) Lead Advisory Board meetings and KOL/Expert panels Provide medical and scientific expertise to the development of product, R&D, and Clinical Development plans Identify prospective principal investigators and key opinion leaders Contribute to regulatory dossiers and NDA submissions, participate in interactions/meetings with FDA, EMA, and other regulatory agencies Program management including people leadership, budget management, risk and contingency planning, etc. Contribute to publication planning; author publications as needed or applicable Skills & Qualifications: MD (or equivalent), PhD, or PharmD is required 5+ years of Clinical Development experience is required Expertise in Hepatology, Nephrology, Pulmonology, or Critical Care is strongly preferred Direct Medical Affairs experience is strongly preferred Experience working with global regulatory bodies (FDA, EMA, etc.) is required Experience in a Medical Device company is strongly preferred Compensation & Benefits Base Salary: $240,000-$260,000 Annual Bonus: 25% Long-Term Incentive package comprised of company stock (estimated value $60,000) Option for 100% remote (open to candidates in the continental USA) Excellent medical, dental, vision, and life insurance Generous PTO and sick leave policy
US$240000 - US$260000 per annum + 25% annual bonus, 25% RSU-based LTI
Bridgewater
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Head of Clinical Program Management (M/F/D)
This is an exciting opportunity to Join a Rapidly Growing Biotech Company as Clinical Program Head in Basel Our biotech client based in the city of Basel is seeking an experienced and driven individual to join their team as a Head of Clinical Program Management (M/W/D) . Our client is focused on developing next-generation oncology products, with the aim of bringing new hope to cancer patients worldwide. This is an exciting opportunity to work for a company that is dedicated to making a real difference in the lives of others. Responsibilities: As the Clinical Program Head, you will be responsible for overseeing clinical development programs from Phase I through regulatory submission. This includes developing protocols, study reports, investigator brochures and other relevant documentation. You will also manage cross-functional teams including medical affairs, data management and statistical analysis groups. Your expertise and leadership skills will be utilised to ensure the successful execution of clinical trials and programs. As the Clinical Program Head, you will be involved in the development of the clinical development strategy, and will work closely with the senior management team to ensure that this is aligned with the overall corporate strategy. You will have a key role in the development of the annual clinical development plan, and will be responsible for the delivery of this plan within the agreed timelines and budget. Experience / Professional Requirements: - MD degree - Advanced knowledge in relevant disease area(s) is essential. - Minimum of 6 years of experience in clinical drug development, including demonstrated leadership and accomplishments in designing and conducting clinical trials (e.g., planning, executing, reporting, and publishing). - People management experience is required, including matrix management. Required Competencies: - Ability to leverage scientific, clinical, and technical knowledge with excellent communication skills. - A strategic thinker with strong influencing and negotiation skills; regulatory experience would be advantageous. - Possesses excellent organisational skills. - Demonstrates knowledge of Good Clinical Practice, clinical trial design, and the drug development process. - Has a working knowledge of oncology- and nuclear medicine-specific aspects of clinical development. - Able to travel internationally (anticipated requirement: 20% of the time). - Fluent in English (both oral and written). As the Clinical Program Head, you will be required to work closely with a range of stakeholders, including clinical investigators, regulatory authorities, and key opinion leaders. You will need to be able to build effective working relationships with these stakeholders, and will be expected to represent the company at external meetings and conferences. Our client is committed to the development of its employees, and as such, the successful candidate will have access to a range of training and development opportunities. These will include both internal and external training courses, and the opportunity to attend industry conferences and events. If you're interested in joining this dynamic company working towards finding solutions that will change people's lives forever then please apply today! This is an exciting opportunity to work for a company that is dedicated to making a real difference in the world of oncology.
Negotiable
Basel
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Clinical Trial Manager/Senior Manager
Location: Singapore Therapeutic Areas: Oncology, Cardiovascular, Infectious Disease, CNS/Neuroscience An award-winning global Clinical Research Organisation with international reputation in providing Phase 1 to Phase IV clinical development services is looking for a Clinical Trial Manager to be based in Singapore This opportunity provides amazing growth potential, career progression and the chance to be working with a growing company. Responsibilities: Lead projects for multi-service global clinical trials Manage project timelines and deliverables Lead cross functional teams - clinical monitoring, study start-up, regulatory, contract, safety, medical monitoring. Secure new businesses Requirements: Bachelor's degree (Masters or PhD preferred) Relevant experience in clinical trial management in Asia, in a CRO is preferred Preferably a tertiary education in law and/or experience within the Chinese legal jurisdiction Good communication skills and team spirit If you are interested, please apply with your CV attached.
Negotiable
Singapore
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Lead Scientist (Study Director)
๐ Job Opportunity: Lead Scientist (Study Director), Viral Clearance Company: Join a leading multinational leader in the CDMO industry, responsible for development and characterization manufacturing processes used for the production of novel therapeutic recombinant proteins for their client base. We are currently seeking a dynamic and passionate Lead Scientist to join our team in Singapore. Key Responsibilities Function as a Study Director, who has the overall responsibility of planning and conducting, as well as the interpretation, analysis, documentation and reporting of results Design viral clearance studies in accordance with guidelines (e.g. EMEAand ICHQ5A) and perform hands-on laboratory work (e.g. small-scale control run, virus models spiked run, virus inactivation step evaluation, virus reduction filtration) following protocols and working to GMP standards. Follow work procedures to set up and operate chromatography, ultrafiltration and dead-end filtration systems to GMP standards. Review and interpret raw data to produce good quality process knowledge and data sets suitable for inspection by regulatory agencies. Authoring of protocols and reports and interaction with regulatory agencies required. Supervision of project teams and leading troubleshooting activities required. Develop and manage relationships with external customers and teams at contract testing laboratories. Deliver high quality communication to ensure an outstanding customer experience (written reports, telecons, face to face meetings). Work as part of a site and global project team, co-ordinate multiple projects and ensure timely delivery of project workstages. Requirements: Degree/PhD in Biological Science/Engineering as appropriate for area of expertise. 4-7 years' experience or 2-5 years and a PhD with experience gained in a lab either in industry or academia, or via an industry work training programme. Practical laboratory experience in virus clearance studies, study directing and project management is required. Developing a detailed understanding of the scientific rationale behind one or more technical areas involved in the development of biopharmaceuticals. The final role offered will be commensurate with the candidate's experience. Understanding of cGMP regulations and quality management is required. Excellent problem solving and analytical skills. Excellent communication skills (verbal and written). Excellent team work skills. How to Apply: If you are enthusiastic about making a meaningful impact in the field of the CDMO industry and possess the required qualifications and experience, we invite you to apply for this exciting opportunity. Please submit your resume to this job advert.
Negotiable
Singapore
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Senior Manager Biostatistics
Client: Clinical-Stage Biotech - Publicly Traded Hiring: Senior Manager, Biostatistics (Third most senior in the company) My client is a cutting-edge clinical-stage biopharmaceutical company on their quest for groundbreaking advancements - The only one to get to commercialization! They are looking to bring on a dynamic Senior Manager, Biostatistics to become the 3rd most senior member within the company. You will have the opportunity to really advance your career, by working closely with the Head of the department and Associate Director on submissions and commercialization of an innovate product. You'll be at the forefront of innovation, working on data analysis of studies linked to a rare technology which is booming at he moment. You will work hand-in-hand with their brilliant statisticians, programmers and clinical teams to craft top-notch deliverables that redefine industry standards. Are you ready to unleash your creativity, collaborate with the best, and drive transformative change? If you're a proactive, visionary thinker who thrives on challenges, then this is the opportunity you've been waiting for! Apply now and be part of a team that's shaping the future of healthcare! Responsibilities: Work closely with CROs on the oversight of statistical and programming deliverables Provide ideas in evaluating innovative methods of study design and analysis Collaborate with other teams - Clinical, Programming and Data Management, to ensure data collection and reporting is correct and appropriate Support on the entire drug development on biostatistical input - study and program design, writing of protocols, CSR, Regulatory documents, SAP, Scientific publications Qualifications 2-3+ years' experience in either research or industry, post PhD PhD in either Biostatistics or Statistics Ability to work onsite in California Please note, to apply for this position you must have rights to work in the USA or a Canadian citizen looking to make the move to California. Reach out to find out more!
Negotiable
California City
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Clinical Scientist/Senior Clinical Scientist
Clinical Scientist/Senior Clinical Scientist Salary: ($100,000-$150,000) Remote (USA) This medical device company launched the first device of its kind. They've received over $500M in investment in the past 2 yearsโฆ so runway is not in question here. While this organization is being backed by one of the largest med dev companies in the world, it is still operating with complete autonomy. The team is looking to bring on a new Scientist/Sr. Clinical Scientist in a remote capacity. Responsibilities: Lead the design and planning of clinical trials for medical devices, ensuring alignment with regulatory requirements and company objectives. Oversee clinical trial operations, including site selection, data collection, and adverse event reporting, to ensure high-quality study execution. Analyze and interpret clinical trial data, prepare study reports, and contribute to regulatory submissions and publications. An ideal candidate for this role will have: Medical device clinical trial experience in Peripheral Artery Disease Experience of clinical documentation preparation, including protocol, ICF, CSR, IB, presentation and publications. Advanced degrees (MD, PhD, or Masters) 2+ years of clinical scientist experience on the sponsor side This company offers a competitive compensation plan: Annual bonus Insurance 401(k) plan PTO If you're interested in this role, please apply now!
US$100000 - US$150000 per year
United States of America
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