Head of Medical Science
4 weeks ago
As Head of Medical Science, you will play a critical role in shaping the scientific vision and medical strategy of our client. Reporting directly to the Chief Medical Officer, you will lead efforts to bridge clinical science and pre-clinical development, ensuring alignment with our mission to deliver transformative therapies to patients. This involves high level strategic planning as well as significant hands-on responsibilities to support our growing pipeline. Core responsibilities include overseeing the design, oversight, and reporting of clinical trials that meet the highest standards of excellence for ethics, scientific merit, and regulatory compliance. Key Responsibilities Management of overall study planning, study execution, and delivery of multiple global clinical programs. Including but not limited to oversight of and accountability for the collection of high-quality clinical data. Oversee review and interpretation of efficacy and safety data. Contribution to clinical trial safety oversight by participating in safety review and analysis of clinical trial data consistent with Safety Review Plan. Close collaboration with Clinical Operations, Toxicology/Pharmacology, Preclinical, Regulatory, Biostatistics, and outside contractors to ensure the successful strategic integration of clinical development plans and strategies. Contribute to authoring, review, and approval of required clinical study protocols, clinical study reports (CSRs), sections of regulatory documents such as Investigators Brochures, briefing books, safety updates, IND/CTA submission documents, and responses to Health Authorities questions. Collaboration with CMC/clinical suppliers to provide clinical trial supply assumptions and contribution to design and packaging of supplies for clinical trials. Communication with internal and external teams in a high impact, highly visible fashion through written and verbal means. Qualifications: PhD, PharmD, or MD Minimum 10+ years of biopharmaceutical industry drug development experience, early through late-stage development, including the design and conduct of early and late phase clinical studies. CNS/Neuroscience experience strongly preferred. Proven ability to lead a multidisciplinary team toward a successful outcome. Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple geographic regions. Excellent strategic and project management skillset with drug development programs Ability to work with the Senior Management Team and other external audiences such KOLs and regulatory bodies. Ability to thrive in highly entrepreneurial biotech environment, with some prior experience in a small/medium size company an advantage. Hands-on, roll-up-the-sleeves when necessary, leader who understands the need for involvement in a small company environment while recognizing when to delegate and seek results from the team. Thorough understanding of country-specific, FDA (and equivalent), ICH and GCP guidelines as well as cross-functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and study reporting. Excellent interpersonal, communication, negotiation and influencing skills. Experience having managed significant accelerations and challenges in clinical programs is desirable. Ability to travel domestically and international (up to 10% of the time) #J-18808-Ljbffr
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Boston, United States The Medical Affairs Company Full timeDirector Medical Science Liaison, Rare Disease TMAC - Boston, MA, United States Tagged: Rare Diseases, Medical Science Liaison, TMAC Direct Hire, Director, Field Medical TMAC’s Direct Hire service is an executive search firm and Pharma’s Complete Recruiting Resource. Thank you for taking the time to review this opening!One of our clients focusing on rare...
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Head of Research
2 weeks ago
Boston, United States Kelonia Therapeutics Full timeHead Of ResearchHere at Kelonia Therapeutics, we aren't just a clinical company; we're trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; dreamers on a mission to bring the promise of cell and gene therapy to every patient in need.We've gathered a group of pioneers in cell and gene...
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Social Media Marketing Manager
3 days ago
Boston, Massachusetts, United States Museum of Science Full time $76,000 - $95,000 per yearWho We AreAs science and technology increasingly shape our lives, the Museum of Science strives to equip and inspire everyone to use science for the global good while keeping up with the pace of change. Among the world's largest science centers and New England's most attended cultural institution, we engage nearly five million people a year – at Science...
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Head of Engineering
2 weeks ago
Boston, United States Rapid Liquid Print Co. Full timeRapid Liquid Print is seeking Head of Engineering to coordinate and lead the various teams in the development and productization of RLP hardware, software, and material portfolio. The head of engineering is the conduit between these three key pillars of the RLP technology with the business and product direction of the company. This role requires a technical...
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Head of Research
3 weeks ago
Boston, United States Kelonia Therapeutics Full timeHead Of Research Here at Kelonia Therapeutics, we aren't just a clinical company; we're trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; dreamers on a mission to bring the promise of cell and gene therapy to every patient in need. We've gathered a group of pioneers in cell and gene...
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Head of Engineering
2 weeks ago
Boston, United States Ai Lean Full timeAi Lean is a fully automated collections and compliance SaaS solution tailored for self-storage operators, aimed at reducing debt, improving cash flow, and boosting operational efficiency. The platform streamlines the process from early collections to auction completion, equipping operators with the tools to make informed decisions and maximize...
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SongLife Head of Strategy
3 weeks ago
Boston, United States Boston Staffing Full timeAccenture SongLife Head Of Strategy Health & WellnessWe Are Accenture SongLifeA Partner for Growth The Agency of Record model we all grew up with was built for stabilitylong planning cycles, rigid campaigns, and success measured in outputs. Today demands something more. With evolving pipelines, diverse patient populations, and accelerated launches, the...
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Boston, United States Get It - Hospitality Full timeJoin us in transforming immunology and delivering medicines that help autoimmune patients regain their lives. We are preparing for a multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, with the potential to treat patients...
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Boston, United States Argenx SE Full timeHead of Neuromuscular Therapeutic Area, US Medical Affairs page is loaded## Head of Neuromuscular Therapeutic Area, US Medical Affairslocations: Boston, MA, USAtime type: Full timeposted on: Posted Yesterdayjob requisition id: REQ-3753*Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is...
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Head of Artificial Intelligence
2 weeks ago
Boston, United States Plymouth Rock Assurance Full timeAbout the RoleWe are seeking a visionary Head of Artificial Intelligence to drive new strategic AI initiatives across Plymouth Rock. In this leadership role, you will conceive and help oversee AI initiatives across the organization, collaborating with cross-functional teams to deliver innovative, cutting-edge solutions. The ideal candidate will combine deep...
