- Kailera Therapeutics, Inc. (Waltham, MA)
- …perspectives, and experiences to join our team. What You'll Do: The Director of Clinical Data Management plays a key role within Clinical Development ... timely delivery and high-quality execution of Data Management deliverables. In this role, the Director ...efforts. This position reports directly to the Head of Clinical Data Management . Preferred location:… more
- Bristol-Myers Squibb Company (Devens, MA)
- …team. Bristol Myers Squibb is seeking a driven and experienced Associate Director , Manufacturing and Process Support Innovation Lead to lead the transformation of ... Devens Cell Therapy business processes including deviation management , change control, and process support activities as part of the site GoSolo program. This… more
- Alkermes (Waltham, MA)
- …Strong knowledge of ML algorithms, statistical analysis techniques, and end-to-end MLOps management . Experience with last-mile data engineering and data ... Job Description JOB DESCRIPTION Position Summary As an Associate Director within the INDIGO | AI Innovation Lab, you...stakeholder management innovation Strong leadership and project management skills, with experience mentoring junior data … more
- Akebia Therapeutics (Cambridge, MA)
- …to effectively manage interactions between functional groups such as monitoring, data management , biostatistics, medical writing, safety, regulatory affairs and ... in, are you? Job Summary: Reporting to the Sr. Director , Clinical Operations, the successful candidate will...Management for ensuring studies stay within their approved clinical project budgets. Accountable for management of… more
- TransMedics (Andover, MA)
- …developed to maximize the utilization of donor organs in the US. As our Director of Electrical & Systems Engineering at TransMedics you will have the unique ... expand access to life-saving organs for patients in need. POSITION SUMMARY The Director of Electrical & Systems Engineering will plan, design, and oversee the… more
- Newfire Global Partners (Boston, MA)
- …a current healthcare client. This new platform will serve as the foundation for all clinical data and operations across every line of business. By creating a ... Senior Director of Engineering (Advisory Services) Department: Engineering Employment...and innovative solution, this leader will enable enhanced care management , utilization management , and data -driven… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …true to the best of my knowledge. Job Description Senior Scientific Director , Clinical Pharmacology Boston, MA OBJECTIVES/PURPOSE The Plasma-Derived Therapies ... drug development programs with substantial technical and strategic autonomy, spanning clinical entry through life-cycle management . Drive the clinical… more
- Alkermes (Waltham, MA)
- …vendors, PV partners, electronic clinical and PV data systems, clinical and post marketing PV documents Provide management oversight for and participate ... Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality oversight...in internal systems audits relevant to safety data and regulatory reporting and sample management … more
- Mythic Therapeutics (Waltham, MA)
- …functions including project management , site monitoring, medical writing, biostatistics, data management , clinical supplies, finance, and document ... of Global clinical studies in accordance with timeline, budget and compliance/ data quality goals. The Associate Director will be responsible for evaluating… more
- Dyne Therapeutics (Waltham, MA)
- …diseases and will develop strong knowledge of the Dyne programs (scientific and clinical data , patient population, market environment, etc.). The Program Manager ... the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and...us on X, LinkedIn and Facebook. Role Summary: The Director , Program Management (PM) is a critical… more
- Kymera Therapeutics (Watertown, MA)
- …analysis and interpretation of clinical trial data , working closely with Clinical Development, Biostatistics and Data Management teams to ensure ... transparency from everyone. Our goals are shared, our decisions data -driven and our camaraderie genuine. BELONG : We recognize...and heard. How you'll make an impact: The Senior Director , Clinical Operations is a leadership role… more
- Eli Lilly and Company (Boston, MA)
- …team leader who holds accountability for the scientific strategy and overall program management , and the Clinical Research Coordinator (CRC) and other cross ... GCP and the management of medical safety in the context of clinical trials (either the investigator or sponsor side) Strong computer skills; Word, Excel,… more
- Zenas BioPharma (Waltham, MA)
- …, Pharmacovigilance role is responsible for providing medical oversight of safety data from clinical trials to ensure proactive and timely benefit-risk ... ICH guidelines and regulations Experience working with CRO/vendors, and relationship management preferred Excellent clinical judgment and ability to communicate… more
- ARTBIO (Cambridge, MA)
- …will partner with clinical operations, regulatory, medical writing, clinical pharmacology, stats/ data management /programming, project management ... Summary The Senior Medical Director is a medical oncologist or a radiation...study reports and DSURs. Leads and when necessary supports clinical study start-up, data base locks, and… more
- Nuvalent, Inc. (Cambridge, MA)
- …consisting of non- clinical safety, DMPK/ clinical pharmacology, biostatistics, clinical operations, data management , pharmacovigilance, and regulatory ... company building. The Role: Reporting to the Vice President, Clinical Development, the Senior Medical Director , ...visits *Provide medical review, assessment and interpretation of all clinical data reported in clinical … more
- CSG (Cambridge, MA)
- …brochures, study reports, and annual updates. Partner cross-functionally with regulatory, clinical operations, data management , pharmacology, and medical ... Position: Senior Medical Director - Oncology Clinical Development We're...regulatory submissions. Act as the primary reviewer for safety data and clinical trial deliverables, including investigator… more
- Clark University (Worcester, MA)
- …thriving cultural scene, and as a vibrant food hub. Job Description: The Director oversees non- clinical interventions and upstream solutions that foster student ... well-being, retention, and persistence. The Director leads and supervises the Care case ...management trends and outcomes. Analyze trends in Care data to identify systemic challenges and recommend policy improvements… more
- AstraZeneca (Boston, MA)
- …studies. Thorough understanding of the full drug development process, including interpretation of non- clinical data and clinical study design and execution. ... Global Clinical Physician Lead, Executive Director , Neuroinflammation,...and the wider organization to transform trends and emerging data into innovative clinical strategies Provide impactful… more
- Akebia Therapeutics (Cambridge, MA)
- …signal management and/or risk management . Experience with safety data collection and interpretation originating from clinical trials and other sources ... all in, are you? Job Summary: The Senior Medical Director is responsible for safety strategy and major safety...practices. Essential Functions and Duties Analyzes, reviews, and interprets clinical and post-marketing safety data Lead, oversee… more
- Lowell Public Schools (Chelmsford, MA)
- …staff. 9. Assist with the establishment and supervision of appropriate reporting, tracking and data management systems. 10. Assist with the creation of a viable ... and program design. 2. Assist with the implementation of educational and clinical services specified in each student's lndividual Educational Program (lEP). 3.… more
