Senior Clinical Project Manager (m/f/d) - Medical DevicesResponsibilities:Lead and manage both local and international clinical trials, specifically focusing on medical devices.Oversee and coordinate internal and cross-functional clinical trial teams, ensuring internal deliverables are met while managing budgets, forecasts, and timelines.Contribute to the preparation, review, and approval of key documents, including clinical study protocols, reports, plans, and informed consent forms.Regularly provide up-to-date reports on study status using internal information systems and tracking tools.Select and qualify clinical trial vendors, develop and implement sponsor and vendor oversight plans, and evaluate key performance indicators.Maintain effective communication and manage relationships with stakeholders, ensuring escalation processes are followed when necessary.Ensure compliance with internal SOPs and relevant regulatory requirements, while identifying quality risks and implementing corrective actions.Support quality audits and collaborate with relevant departments to manage Corrective and Preventive Actions (CAPAs).Foster an open, trust-based working environment and drive change to promote continuous improvement.Contribute to the enhancement of internal processes, including SOPs, Work Instructions and the implementation of new IT/software initiatives.Requirements:University degree (Bachelor's) in life sciences, medical healthcareAt least 4 years of experience managing complex, international clinical trials with medical devices in both pre- and post-market stages.Over 8 years of comprehensive experience across various medical indications, study designs, and phases of clinical development for medical devices or medicinal products.In-depth knowledge of clinical research practices and regulations (ICH-GCP, ISO 14155, MDR, FDA, EU-CTR, etc.), as well as experience with clinical trial application submissions.Strong experience leading interdisciplinary, international teams and providing leadership in a cross-functional environment.Team player with demonstrated professional leadership skills.Proven ability to develop tools and processes to enhance project efficiency.Experience with IVRS and EDC systems.Solid understanding of project management methods and tools (e.g., MS Project).About the Client: This company offers a great working environment with a global perspective and the opportunity to work in an international team. The flexible hybrid model allows you to work 2 days in the office and 3 days remotely. With an average employee tenure of over 8 years, the company provides long-term stability and growth opportunities. In addition to a competitive salary, employees enjoy attractive benefits such as Wellpass, Jobticket, Jobbike, 39 vacation days, a pension plan, and childcare support.If you're passionate about driving clinical trials forward in the field of medical devices, with a strong emphasis on cross-functional leadership, efficiency, and quality compliance, we encourage you to apply.I´m looking forward to seeing your application! Contact details:E-Mail: M.Inderhees@sciproglobal.deTel: 089 26 20 09 25

Our client is a small, private clinical-stage biotech developing I&I therapies with best-in-class potential through a range of developmental modalities.The company has forged strategic partnerships with a multitiude of global biotechs, the most recent granting them another ~$200M in additional funding. With the launch of mutilple global Phase II trials, they're looking to add a physician to the team to lead the programs and directly support the CMO. Responsibilites: Drives clinical strategy, overseeing development planning and cross-functional execution while ensuring alignment with corporate goals and optimizing time, resources, and risk.Partners with internal teams and external experts to craft innovative clinical plans. Acts as the clinical lead on core program teams, offering strategic guidance and managing timelines.Directs clinical input for the Product Development Plan, ensuring high-quality contributions. Communicates development strategies and key recommendations to senior leadership and stakeholders.Chairs the Internal Safety Committee, supervising safety monitoring across clinical studies. Oversees medical monitoring and participates in advisory panels and investigator meetings.Contributes to clinical protocols, study reports, and publications, supporting a data-driven publication strategy. Collaborates with academic investigators to share findings in scientific forums.Maintains up-to-date knowledge of regulations, guidelines, and therapeutic advancements, promoting best practices. Represents the company in the medical and scientific community to foster collaboration and industry leadership.Analyzes and interprets efficacy and safety data to generate key insights, aligning messaging with product strategy and clinical applications.Qualifications: MDProven track record of experience and leadership in clinical trials/drug developmentPractical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodiesExperience with Rheumatology, Immunology, or Autoimmune diseases preferredAbility to manage multiple and diverse internal/external collaborations at different stages of developmentExcellent listening and collaboration skill

Our client is a public, mid-size (~350x heads) biotech using their proprietary gene therapy platform to develop potentially transformative treatments for serious diseases.The company has forged strategic partnerships with major biopharma companies including a development partnership for therapies with blockbuster potential with a Top Ten Global Big Pharma, and licensing agreements with companies leveraging our client's technology for treatments targeting rare genetic conditions.With an upcoming BLA submission, they're looking to add a physician to the team to lead their internal CNS program, as well as take on another CNS development program in the future.The opportunity: As Senior Medical Director, you will lead the development of a transformational gene therapy. You will play a key role in shepherding the candidate drug from pre-clinical stages through launch and lifecycle management. Responsibilites: Responsible for shaping clinical strategy, including development planning and cross-functional execution. Ensures alignment with corporate objectives while balancing time, resources, and risk.Collaborates with internal teams and external experts to design innovative clinical plans. Serves as the clinical lead on core program teams, providing strategic input and overseeing timelines.Leads clinical contributions to the Product Development Plan and ensures high-quality clinical sections. Presents development strategies and recommendations to senior leadership and key stakeholders.Chairs the Internal Safety Committee, overseeing safety monitoring across clinical studies. Manages medical monitoring activities and engages in advisory panels and investigator meetings.Reviews and contributes to clinical protocols, study reports, and publications, supporting a data-driven publication strategy. Engages with academic investigators to present and publish findings in scientific forums.Maintains expertise in regulations, guidelines, and therapeutic areas, ensuring best practices. Represents the company in the medical and scientific community to foster collaboration and thought leadership.Develops strong data analysis skills to interpret efficacy and safety outcomes, shaping key messages in alignment with product strategy and clinical practice.Qualifications: MDProven track record of experience and leadership in clinical trials/drug developmentPractical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodiesExperience with gene or cell therapies and/or rare orphan diseases preferredAbility to manage multiple and diverse internal/external collaborations at different stages of developmentExcellent listening and collaboration skill

Medical Safety Director Hybrid - Cambridge, MA Competitive Compensation Package Based on Experience$270,000 - $300,000 + Annual Bonus + Stocks SciPro Global is exclusively partnered with a Stable & steadily growing biotech that is doing incredible work with a pipeline across the Immunology and Oncology space. As their pipeline progresses, there are positions opening up in their Safety group. This group is solution oriented and full of team players, while being led by a direct, passionate, and impressive leader in the US. This position will report directly into the Senior Director Pharmacovigilance & Safety and provides unlimited career growth & stability with the technology that they are working on. Responsibilities include (but not limited to):Safety analysis of both clinical trials & post marketed products.Leading clinical safety aggregate reports such as PADERS.Leading risk mitigation and risk minimization measures for global studies, specifically working with RMPs.Responding to health authority queries regarding safety & risk sections of regulatory documents.Perform signal management & lead signal strategy measures.Safety surveillance of all assigned products.Cross functionally act as Safety SME for assigned products & liaise with other Clinical counterparts across the organization.Communicate safety updates with external & internal stakeholders.Provide safety input for clinical study design activities.Identify ways of improvement for team & safety group. Requirements include (but not limited to):Medical Director or Foreign Equivalent.Minimum 4 years of Safety experience working at a biotech or pharma.Strong signal detection experience required.Experience as safety lead for investigator brochures.Phase 1 Safety review experience.Solution Oriented mindset & motivated! Are you looking to join an exciting company to grow your career? Apply now to begin the process!

Vice President of Safety REMOTE Competitive Compensation Package Based on Experience One of SciPro Global's standing partners is looking to make their first Safety hire as their pipeline progresses. Our partner is an exciting Clinical stage Immuno-Oncology biotech located in the Massachusetts area. With impressive Clinical progress across different indications and growth over the last year or so, it's now time to make the key hire of a Head of Safety. This individual will be responsible for leading Strategy for safety, pharmacovigilance, and risk, build and manage the team, and collaborate cross functionally. As safety has been outsourced to this point, you will have the opportunity to bring it in house and develop the department accordingly. Reporting directly into the the SVP of Clinical Development, this role will be integral in the organization. Responsibilities include (but not limited to):Provide Safety expertise for all programs in pipeline both in the IO and ADC space.Managing existing PV team member & building the rest of the team.Strategically drive Safety forward while ensuring regulatory compliance.Lead, author and review clinical safety aggregate reports.Leading risk mitigation and risk minimization measures.Responding to health authority queries regarding safety & risk sections of regulatory documents.Perform signal management & lead signal strategy measures.Collaborate cross functionally with clinical development, regulatory, and quality assurance teams.Communicate safety updates with external & internal stakeholders. Requirements include (but not limited to):Medical Doctor or Foreign Equivalent.Minimum 15 years of Pharmacovigilance & Safety experience at a Biotech or Pharma.Experience leading a product through submission.Oncology experience preferred. Are you looking to join an cutting edge company to help the future of Oncology? Apply now to begin the process!