Director Clinical Science
We're looking for a Director, Clinical Scientist to play a pivotal role in Translational Research and Clinical Development. This is a fantastic opportunity for someone with strong analytical skills, deep expertise in clinical trials, and a passion for advancing oncology research. Key Highlights of the Role: โ
Lead and review Clinical Development documents (protocols, informed consent, regulatory submissions, abstracts, manuscripts). โ
Drive translational research strategy, including vendor selection, data analysis, and collaboration with Biostatistics. โ
Represent Clinical Science in operational and cross-functional team meetings. โ
Ensure data integrity and consistency in clinical site reporting. โ
Stay at the forefront of scientific advancements in oncology research. Who We're Looking For: ๐น PhD or PharmD with 10+ years of clinical trial experience (including 5+ years in pharma/biotech). ๐น Strong background in data analysis, protocol development, and scientific writing. ๐น Experience in oncology and clinical data listing review is a huge plus!
US$200000 - US$250000 per year
Minneapolis
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Medical Director - Psychiatry
EPM Scientific are on the lookout for a top tier candidate to fill a vacancy with a client of ours on a 2 year contract as a Medical Director, Duties and responsibilities will be listed below. We are seeking a highly experienced Senior / Medical Director, Neuroscience with a focus on Psychiatry. This role is central to ensuring the success and compliance of clinical trials, advancing research in psychiatric disorders, and upholding the highest standards of patient safety and data integrity. Key Responsibilities Patient Safety and Ethics: Ensure the safety, rights, and well-being of study participants, upholding ethical and regulatory standards. Medical Monitoring: Oversee safety and efficacy data reviews, assess adverse events and serious adverse events, and analyze clinical data to identify trends, safety signals, and study outcomes. Protocol Development: Collaborate with cross-functional teams to design clinical trial protocols, informed consent forms, and case report forms. Regulatory Compliance: Ensure clinical activities adhere to ICH-GCP, FDA regulations, and other applicable standards. Team Collaboration: Partner with sponsors, clinical sites, project managers, regulatory teams, and statisticians to ensure smooth trial operations. Training and Support: Provide training to study staff on psychiatric assessments, safety monitoring, and adverse event reporting. Qualifications Medical degree (MD or DO) with a specialization in Psychiatry. Proven experience in clinical research, particularly in schizophrenia, bipolar disorder, and major depressive disorder. Experience in Neurology or other Neuroscience indications is a plus. At least 2 years of experience as a Medical Director or 5+ years for a Senior Medical Director role. Strong knowledge of clinical trial design, GCP, and regulatory requirements. Exceptional analytical skills, attention to detail, and proficiency with clinical trial management tools. Excellent communication and interpersonal skills to foster collaboration in a team environment. Preferred Qualifications Board certification in Psychiatry. Experience with medical data evaluation and safety reporting. Familiarity with statistical analysis and data interpretation. If interested, please respond with an up to date resume and expect to hear back soon!
Negotiable
United States of America
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Sr. Medical Director Clinical Development
Sr. Medical Director Clinical Development Remote Compensation: $320,000-3900,000 + Bonus + Equity Company Summary: We are partnered with an innovative ADC-focused biotech experiencing significant growth this year. Their unique approach utilizes previously inaccessible targeting molecules and novel payloads, positioning them as a leader in ADC development. They have two lead programs in Phase 1 targeting high-need solid tumors, with promising preclinical results. The leadership team is highly experienced, with the CMO having brought three novel drugs to market. They raised over $130 million in their series B last year and secured deals with major pharmaceutical companies worth over $1 billion. They are seeking a Clinical Development Leader for one of their Phase 1 assets. Primary Responsibilities: Lead the clinical development strategy for Phase 1 assets. Oversee the design, implementation, and execution of clinical trials. Collaborate with cross-functional teams to ensure alignment on clinical development goals. Provide medical and scientific expertise to support regulatory submissions and interactions. Build and maintain relationships with key opinion leaders and stakeholders in the oncology field. Contribute to the strategic planning and growth of the clinical development team. Monitor and analyze clinical trial data to ensure accuracy and integrity. Develop and manage clinical development budgets and timelines. Ensure compliance with all regulatory and ethical standards. Mentor and train junior clinical development staff. Represent the company at scientific conferences and industry meetings. Drive innovation in clinical trial design and execution to enhance efficiency and outcomes. Perform other duties as assigned. Ideal Qualifications: 4+ years clinical development experience MD or foreign equivalent. Oncology experience in industry
US$250000 - US$390000 per year
Boston
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Process Modelling Scientist
Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process? We have an exciting opportunity for you! Our Client is a market leader in the Biopharmaceutical Industry. They are looking to hire a top Process Modeling Scientist Tasks Develop models to enhance bioreactor processes. Use mathematical equations, probability-based methods, and machine learning to build these models. Apply control techniques to manage and improve the processes. Test the models to ensure they work correctly. Identify any errors and find ways to improve their performance. Focus on making the models faster, more accurate, and scalable. Analyze data to uncover valuable patterns and insights. Enhance the models by adding relevant features to improve their accuracy and effectiveness. Assist in creating prototypes to test new ideas and technologies. Ensure that these prototypes function as expected and meet project goals. Work closely with biopharma experts to ensure the models solve real-world challenges. Collect feedback from customers to refine the models and make them more useful. Stay up-to-date with advancements in machine learning and biopharma technologies. Explore innovative ways to improve processes, control methods, and decision-making. Collaborate with engineers and product managers to develop solutions that are user-friendly, efficient, and scalable. Profile Skilled in advanced simulation techniques like probabilistic modeling, neural networks, Gaussian processes, neural ODEs, SDEs, PDEs, mathematical optimization, control theory, and sensitivity analysis. Experienced with Python and data science tools like NumPy, SciPy, Pandas, TensorFlow/PyTorch/Jax, Scikit-learn, and libraries for data visualization. Familiar with managing data pipelines using tools like Flyte, Apache Spark, and Airflow, as well as cloud platforms such as AWS and Azure. Good understanding of biopharma data, including upstream processes and bioreactor behavior. Nice to have Experience with explainable AI (XAI) to create models that are easy to understand. Previous experience in biopharma process modeling, especially in the early stages of production, is a plus. Experience creating and managing data pipelines for real-time data analysis. Strong understanding of combining traditional modeling with machine learning methods. Contact Please contact me on ammar.nabi@phaidoninternational.com or please call me on +49 30 726211428 for further information.
Negotiable
Stuttgart
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AD Clinical Development
Position Summary The Associate Director of Clinical Development will play a key role in planning and executing clinical trials while providing strategic input into clinical development programs. This position requires a combination of scientific expertise, project management skills, and leadership capabilities Job Responsibilities Will report to a senior member of the Clinical Development team who has direct responsibility for the overall research strategy and clinical development activities for the urticaria and stem cell programs. - Will lead the design, implementation, and execution of clinical trials from Phase I-III -Will participate in and/or lead cross-functional matrix team meetings including stakeholders from clinical operations, medical affairs, regulatory affairs, and biostatistics. - Develop and review clinical trial protocols, informed consent documents, and other study-specific plans and essential study materials - Collaborate with study team, investigators and study sites to ensure trials are conducted according to protocol, GCP guidelines, and regulatory requirements - Monitor trial progress, timelines, and budgets while implementing risk mitigation strategies -Responsible for clinical aspects of data review and cleaning of key studies in the urticaria and stem cell programs. - Review and analyze clinical trial data, safety information, and study metrics -Generate study reports, presentations, and publications to communicate findings to internal and external stakeholders -Prepare and/or contribute to clinical study related and other regulatory documents (e.g. IBs, ICFs, SAPs, Data Management Plans, briefing books). Strategic Leadership - Contribute to clinical development plans and product development strategies - Provide scientific and medical expertise to cross-functional teams - Mentor and guide clinical research associates and other team members - Participate in the selection and management of CROs and vendors - Support regulatory interactions and documentation preparation Cross-functional Collaboration - Work closely with Clinical Operations, Biostatistics, Data Management, Medical Writing, Translational, Regulatory Affairs, Technical Operations and other functional teams to support successful execution of clinical development strategy - Engage with Key Opinion Leaders and clinical investigators - Lead strategy and authoring of clinical portions of regulatory submissions, responses to health authorities and ethics committees - Support business development activities as needed
Negotiable
San Francisco
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Executive Medical Director Clinical Development
Executive Medical Director Clinical Development Greater Boston Area (Hybrid) Compensation: $320,000-390,000 + Bonus + Equity Company Summary: We are partnered with an Cell Therapy Biotech focused within Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team has generated multiple successful approvals in the Autoimmune space. With this company being pre-IPO there is great upside to get in now with their Phase 3 anticipated for the end of this year. Primary Responsibilities: Provide critical insights and contributions, and implement comprehensive clinical development plans for the company's molecules, ensuring alignment with scientific, regulatory, and commercial objectives. Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence. Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance. Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders. Gather, analyze, and interpret clinical data, providing strategic insights to inform critical decisions and guide program development. Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones. Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development. Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals. Manage multiple direct reports and be a manager of managers. Qualifications: Some clinical experience desired 3+ years of Industry experience in Biotech Experience in Rheumatology
US$320000 - US$390000 per year
Cambridge
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Key account manager - Lower Saxony
We have a current opportunity for a Key Account Manger focusing on clinical/ Hospital sales on a permanent basis. The position will be based in Lower Saxony. For further information about this position please apply. Role Overview * Primary Focus: Clinical business, with an emphasis on candidates experienced in the clinical market. o Experience Required: 2-3 years in the clinical market, particularly in external clinical sales. o Ideal Profile: Candidates with 3-5 years of experience in clinical field sales, especially in infectious diseases and pain management. o Relevant Connections: Candidates should ideally be familiar with oncologists and intensive care professionals. o Focus: New business development. Key Responsibilities * Client Management: o Strong experience in pharmacy support is required, including attending AMK (drug commission) meetings, understanding regulations, and discussing these with pharmacists when needed. o Knowledge of market access regulations is essential, especially regarding relevant rules and guidelines. o Main client work currently involves market mapping and developing existing clients. * Product Focus: The primary product targets university hospitals, specifically focusing on 25 priority clinics.
ยฃ90000 - ยฃ100000 per annum + + Bonus
Germany
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Executive Medical Director Clinical Development
Executive Medical Director Clinical Development Greater Boston Area (Hybrid) Compensation: $320,000-390,000 + Bonus + Equity Company Summary: We are partnered with an Cell Therapy Biotech focused within Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team has generated multiple successful approvals in the Autoimmune space. With this company being pre-IPO there is great upside to get in now with their Phase 3 anticipated for the end of this year. Primary Responsibilities: Provide critical insights and contributions, and implement comprehensive clinical development plans for the company's molecules, ensuring alignment with scientific, regulatory, and commercial objectives. Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence. Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance. Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders. Gather, analyze, and interpret clinical data, providing strategic insights to inform critical decisions and guide program development. Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones. Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development. Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals. Manage multiple direct reports and be a manager of managers. Qualifications: Some clinical experience desired 3+ years of Industry experience in Biotech Experience in Rheumatology
US$320000 - US$390000 per year
Cambridge
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Executive Medical Director Clinical Development
Executive Medical Director Clinical Development Greater Boston Area (Hybrid) Compensation: $320,000-390,000 + Bonus + Equity Company Summary: We are partnered with an Cell Therapy Biotech focused within Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team has generated multiple successful approvals in the Autoimmune space. With this company being pre-IPO there is great upside to get in now with their Phase 3 anticipated for the end of this year. Primary Responsibilities: Provide critical insights and contributions, and implement comprehensive clinical development plans for the company's molecules, ensuring alignment with scientific, regulatory, and commercial objectives. Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence. Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance. Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders. Gather, analyze, and interpret clinical data, providing strategic insights to inform critical decisions and guide program development. Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones. Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development. Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals. Manage multiple direct reports and be a manager of managers. Qualifications: Some clinical experience desired 3+ years of Industry experience in Biotech Experience in Rheumatology
US$320000 - US$390000 per year
San Francisco
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Executive Medical Director Clinical Development
Executive Medical Director Clinical Development Greater Boston Area (Hybrid) Compensation: $320,000-390,000 + Bonus + Equity Company Summary: We are partnered with an Cell Therapy Biotech focused within Autoimmune diseases. Their proprietary approach will dramatically cut time and cost associated with other cell therapy treatments like CAR-T. Their leadership team has generated multiple successful approvals in the Autoimmune space. With this company being pre-IPO there is great upside to get in now with their Phase 3 anticipated for the end of this year. Primary Responsibilities: Provide critical insights and contributions, and implement comprehensive clinical development plans for the company's molecules, ensuring alignment with scientific, regulatory, and commercial objectives. Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence. Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance. Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders. Gather, analyze, and interpret clinical data, providing strategic insights to inform critical decisions and guide program development. Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones. Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development. Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals. Manage multiple direct reports and be a manager of managers. Qualifications: Some clinical experience desired 3+ years of Industry experience in Biotech Experience in Rheumatology
US$320000 - US$390000 per year
San Francisco
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Associate Director, Clinical Science
Job Type: Full-time Salary: $160,000 - $200,000 Location: Alameda, CA Company Summary: As private equity and VC backed clinical-stage biotech company, their mission is to develop a safe, effective, and affordable first-in-class cell therapy pipeline to treat cancer. To achieve this, they are focused on developing gamma delta T cell therapies with a patented ACC platform that targets immune cells. The Opportunity: The Associate Director, Clinical Science will play a critical role in the design, implementation, and analysis of clinical trials focused on our advance cell therapy programs. Reporting to the Executive Director of Clinical Development, this person will be responsible for collaborating cross-functionally to ensure completion of the clinical studies. Responsibilities: Developing and overseeing clinical trial protocols to ensure alignment with regulatory guidelines and strategic objectives. Leading the cross functional study set up activities for successful conduct of the study, with guidance from the clinical development lead physician. Assisting and/or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests. Performing periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making. Preparing and reviewing clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance. Interacting with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards. Staying abreast of advancements in oncology and cell therapy, integrating new findings into clinical strategies and practices. Providing guidance and mentorship to junior staff on best practices in clinical research and trial management. Requirements: Advanced degree in a relevant scientific discipline (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience. Minimum of 5 years of experience in clinical research (i.e. performing study design, set up, and clinical data review) ' Experience in the following areas are preferred oncology, rheumatology/autoimmune disease, and cell therapy (allogenic or autologous) Regulatory submission experience is a plus. Benefits: Pre-IPO stock options Health benefits (medical, dental, and vision) Competitive salary with comprehensive benefits and PTO 401K contribution Collaboration with biopharmaceutical partners and worldwide academic institutes worldwide
US$165000 - US$195000 per year
Alameda
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Business Development Manager - Switzerland
Business Development Manager - Spine Sector Location: Lucerne, Switzerland Languages: Fluent German and English An global industry-leading medical devices company is seeking a dynamic Business Development Manager to join their Spine sector team. This role offers an exciting opportunity to drive growth and innovation in a highly specialized and impactful area of healthcare. Key Responsibilities Develop and implement strategic plans to expand market presence in the Spine sector. Identify and pursue new business opportunities with a "hunter" mentality, driving revenue and market share. Build and maintain strong relationships with healthcare professionals, key stakeholders, and decision-makers. Collaborate cross-functionally to ensure the successful execution of business strategies. Monitor market trends and competitive landscape to provide insights and recommendations. Qualifications Proven experience in business development, sales, or a related role in the orthopedic or spine industry. Operating room (OR) experience is highly desirable. Demonstrated ability to identify opportunities, close deals, and exceed sales targets. Strong interpersonal and communication skills, with fluency in both German and English. Results-driven, self-motivated, and comfortable working in a fast-paced environment. A passion for healthcare innovation and improving patient outcomes. *This is not a leading role. Ready to take the next step in your career? Apply today to become a key player in shaping the future of spine care.
Negotiable
Schweizer-Reneke
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