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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Global Medical Director
EPM Scientific are currently working with a growing, small biotech Company with an exciting specialized pipeline seeking a Global Medical Director to join their team. See a short summary below; Conditions: Start date: May 2025 Location: Canada (Remote) Interviews: Scheduled immediately Language: English, additional Languages are a plus Project: CNS, Rare Disease Key Responsibilities: Develop and execute global medical strategies for Phase III programs, ensuring alignment with corporate objectives, clinical development, and lifecycle management goals. Build and maintain strong relationships with KOLs, clinical investigators, and healthcare professionals to support scientific and medical objectives. Lead medical affairs activities, including data dissemination, publication planning, and regulatory submissions, ensuring compliance with international frameworks. Act as the medical lead within cross-functional teams, supporting clinical trial design, market access, and commercial strategies. Provide scientific and clinical insights, interpret complex data, and champion innovative, patient-centric approaches to address unmet medical needs. Requirements Extensive expertise in late-stage drug development, lifecycle management, and Canadian regulatory frameworks. Demonstrated success in managing KOLs and fostering strong relationships with clinicians and healthcare professionals. A strategic mindset capable of integrating local and global medical strategies. Outstanding leadership skills with a proven ability to collaborate across functions. Superior communication and presentation skills. Deep scientific and clinical knowledge, with proficiency in analyzing and interpreting complex data. Adaptable to fast-paced, dynamic environments with a strong commitment to innovation and patient-centric outcomes. If this role is of interest to you, please apply directly to learn more about the role. If not feel free to share with your network.
Negotiable
Canada
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Clinical Operations Manager
EPM Scientific are currently working with a growing, small biotech Company with an exciting specialized pipeline urgently seeking a Clinical Manager to join their team. See a short summary below; Contract Conditions: Start date: As soon as possible Location: Europe (Remote) Interviews: As soon as possible Language: English, additional European Languages are a plus Project: Neurology, Rare Disease Key Responsibilities: - Establishing and managing timelines, budgets, and resource plans for clinical trials. - Coordinating and leading cross-functional teams, including investigators, CRAs, lead CRAs, and site coordinators. - Ensuring precision in documentation, data entry, and adherence to regulatory standards. - Fostering a collaborative and high-performing team environment. - Addressing and resolving operational challenges during trial execution. - Navigating unexpected issues while preserving the integrity of the study. - Supervising CROs, laboratories, and other external vendors. - Overseeing site selection, initiation, and ongoing monitoring activities. Requirements: - Strong experience (8-12 years) in Clinical Operations / Development within the biotech or - pharmaceutical industry. - Experience in CNS studies is a plus. - Exceptional written and verbal communication skills. - Strong leadership and organizational skills, with a collaborative approach to teamwork. If this role is of interest to you, please apply directly to learn more about the role. If not feel free to share with your network.
Negotiable
France
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Biosample Operations Manager
Position Summary: We are seeking a highly motivated Biosample Operations Manager with a passion for new cancer therapy development. This role will be responsible for providing leadership to Clinical Development Execution and/or Study Management Team and oversight of laboratory vendors for our clinical programs. As a Biosample Operations Manager, you will represent Clinical Operations and work directly with Biomarker Sciences, Pharmacology, Clinical Data Management, Medical Monitor, and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills, learn new skills, and play a key role in clinical trial planning and execution. As a member of the team, you will help to grow the pipeline. What you'll do: Develop and maintain effective, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders. Manage key service providers (e.g., Central and other laboratories as needed) and CROs to support clinical sample tracking and collection, and sample storage including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study objectives and goals. Implement study-specific biosample analysis plan and data management or transfer agreement for each study. Lead the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data reconciliation and transfer, to final sample disposition, in accordance with study protocol and informed consent. Collaborate with biomarker sciences and pharmacology to oversee all study biosample operational activities and regularly report on status (e.g., reconciling against consent) including Key Performance Indicators. Support biomarker sciences and clinical development on Companion Diagnostics strategy development and lead the study execution on the strategy. Facilitate resolution of sample and data discrepancies. Write or contribute to the preparation of clinical documents (e.g., protocols, informed consent forms, case report forms, laboratory specifications, and manuals). Provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, contributing to the development of patient and site-friendly sample collection materials, to investigators and site staff, vendor staff, and team members. Proactively identify areas of best practice and process improvements. Participate and/or lead Biosample Operations initiatives. Requirements: Bachelor's in life sciences or related discipline with 8-10 years of experience in clinical and drug development. Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples. Extensive clinical trial management experience from study start-up through to close out, particularly in oncology and/or precision medicine early drug development. Familiar with oncology laboratory terminologies as well as genomic biomarker and pharmacodynamic endpoints from tissue and blood samples. Early phase oncology trial management experience preferred. Thorough knowledge of FDA and ICH/GCP regulations and guidelines. Self-motivated and takes pride in your work. Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships. Detailed oriented and creative thinker with a passion for process optimization. Excellent organizational and communication skills. Computer software literate, e.g., Microsoft suite including MS Excel and MS Project, Smartsheet, Adobe, and other clinical systems such as EDC, CTMS, TMF. Analyze and triage problems, prioritize accordingly, and propose solutions. If you are passionate about making a difference in the field of oncology and meet the above requirements, we would love to hear from you!
Negotiable
South 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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