Senior Clinical Development Specialist

5 days ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
About Daiichi Sankyo, Inc.

Dedicated to creating and supplying innovative pharmaceutical therapies, Daiichi Sankyo Group has a rich legacy of innovation and a robust pipeline of promising new medicines. With over 125 years of scientific expertise and a presence in more than 20 countries, the company is committed to improving standards of care and addressing diversified, unmet medical needs globally.

Job Summary

The Senior Clinical Development Specialist will play a critical role in drafting development plans, protocol profiles, protocols, and clinical sections of submission documents under the guidance of CSL and/or Medical Monitor. This position provides essential support to the CSL and Medical Monitor in executing Clinical Development functions.

Key Responsibilities
  • Study Strategy: Drafts development plans under the guidance of CSL and/or Medical Monitor. Contributes to the development of study design to meet study objectives, biomarker/PK strategy, and data quality listings, providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, SAP, and Data Management Plan. Performs literature reviews and creates reference lists for studies.
  • Study Planning: Contributes to clinical trial planning, including identification of potential risks to study deliverables; development of contingency plans; selection of ARO, CRO, and members for DSMB and/or adjudication committees; development of charters for study committees. Provides input to Clinical Operations on monitoring plans and to Biostatistics on Statistical Analysis Plans (SAP).
  • Study Execution: Reviews patient demographics, enrollment, retention, and protocol compliance for consistency with study strategy. Collaborates with lead statisticians on SAP updates and provides input to Clinical Operations on site issues.
  • External Collaboration: Consults with internal experts and external KOLs for protocol development. Participates in study team meetings with CRO and ARO and establishes effective communication with CRO, ARO, and vendors.
Requirements

This role requires:

  • A Master's Degree or equivalent preferred
  • PharmD or equivalent preferred
  • PhD or equivalent preferred
  • Postgraduate training in TA or related specialty, or equivalent preferred
  • 1 or More Years with PharmD, PhD, and relevant clinical experience preferred
  • 4 or More Years with master's degree and relevant clinical experience preferred
Estimated Salary Range

$120,000 - $180,000 per year, depending on experience and qualifications.

Benefits

Daiichi Sankyo, Inc. offers competitive benefits, including health insurance, retirement plans, and paid time off.



  • San Diego, California, United States Affinity Development Group Full time

    Job Title: Senior Web Development SpecialistWe are seeking a talented Senior Web Development Specialist to join our team at Affinity Development Group. As a key member of our web development team, you will be responsible for designing and maintaining content, user interface, and graphic features for our websites and web-based applications.Key...

  • Senior R Programmer

    2 weeks ago


    San Francisco, California, United States Maxis Clinical Sciences Full time

    Job SummaryWe are seeking a seasoned Senior R Programmer with 8-10+ years of experience to join our team at Maxis Clinical Sciences in South San Francisco, CA. The ideal candidate will have expertise in data analysis and clinical trials within the Pharma industry.Key Responsibilities:Design and develop advanced statistical models for clinical trialsAnalyze...


  • San Francisco, California, United States Sodexo Full time

    Job OverviewSodexo is seeking a talented Clinical Nutrition Specialist to support our senior living communities across the United States. As a key member of our team, you will provide exceptional nutritional care to residents and contribute to the overall well-being of our clients.


  • San Francisco, California, United States Lifelancer Full time

    Job DescriptionThe Senior Clinical Trials Operations Specialist is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in...


  • San Francisco, California, United States LHH Full time

    Senior Contract Specialist - Clinical OperationsJob Type: 6-12 Month Contract, Hybrid 3 Days Onsite, Full-TimeEstimated Salary: $50 - $65 per hourLHH seeks a seasoned Senior Contract Specialist to support clinical operations for their client in San Francisco. As a contract expert, you will prepare, review, and negotiate clinical-related contracts to ensure...


  • San Francisco, California, United States Meet Full time

    Meet a dynamic biotech company in San Francisco seeking a Senior Neurology Clinical Development Strategist with a PhD and strong background in neurology for a long-term, remote role.Position OverviewThis innovative position involves driving clinical development strategy in the neurology space by collaborating with cross-functional teams to design, implement,...


  • San Francisco, California, United States Bayone Full time

    We are seeking a skilled Senior Web Development Specialist to join Bayone. The estimated salary for this role is $110,000 annually.About the JobThis position involves end-to-end web app development, from frontend to backend, with a focus on creating responsive user interfaces and designing scalable backend services.Responsibilities:Develop and maintain...


  • San Francisco, California, United States Siza- Buso Consulting Full time

    Job OverviewSiza-Buso Consulting is a rapidly growing health tech startup based in San Francisco, seeking an experienced Senior Software Development Specialist to join their team. This role offers a unique opportunity to contribute to the development of impactful products at the intersection of technology and healthcare.Key Responsibilities:To develop...


  • San Francisco, California, United States Discovery Senior Living Full time

    About the RoleDiscovery Senior Living is a leading provider of upscale senior-living communities in the US, with over 250 communities in nearly 40 states. We are seeking an experienced Interior Designer to manage the interior design and FFE processes for various renovation and new development projects.ResponsibilitiesCollaborate with architects, interior...


  • San Francisco, California, United States Discovery Senior Living Full time

    At Discovery Senior Living, we are committed to providing an exceptional living experience for our residents. As a leader in the senior housing industry, we strive to create engaging and supportive environments that promote overall well-being.We are seeking a skilled Interior Designer to join our team. This detail-oriented professional will be responsible...


  • San Diego, California, United States Senior Living Recruiting Specialist Full time

    We are seeking compassionate professionals to join our team at Senior Living Community, where we prioritize delivering exceptional care and services to seniors. Our mission is to create a warm, welcoming environment that fosters growth, independence, and joy.As a senior care professional, you will have the opportunity to make a meaningful difference in the...


  • San Francisco, California, United States salesforce Full time

    Salesforce is a cutting-edge technology organization dedicated to improving developer productivity in cloud development environments. Our team is pushing the boundaries of innovation, and we're seeking a highly skilled Senior Cloud Developer Experience Specialist to join us.The ideal candidate will have at least 5+ years of software development experience,...


  • San Francisco, California, United States Diverse Lynx Full time

    At Diverse Lynx LLC, we're looking for an experienced Senior .NET Developer Specialist to join our team. With a strong portfolio of completed projects and expertise in .NET CORE, ASP.NET, C#, and MVC Framework, you'll be responsible for developing innovative web applications that meet the highest standards.The ideal candidate will have expert-level skills in...


  • San Francisco, California, United States Boston Imaging Full time

    Boston Imaging, a subsidiary of Samsung Electronics, is seeking an experienced Senior Ultrasound Sales Specialist to drive sales and growth of our ultrasound products in the Point of Care (POC) market segment. This role is ideal for a candidate with a strong background in medical device sales, experience managing expansive geographic territories, and an...


  • San Francisco, California, United States Vir Biotechnology, Inc. Full time

    Company OverviewVir Biotechnology, Inc. is a clinical-stage biopharmaceutical company dedicated to harnessing the immune system's power to tackle life-threatening diseases. With a focus on infectious diseases and cancer, our team works tirelessly to develop innovative treatments that transform lives.Job SummaryWe are seeking an experienced Senior...


  • San Francisco, California, United States Cedent Consulting Inc Full time

    Clinical Outcomes Specialist Position OverviewThe Cedent Consulting Inc. is seeking a highly skilled Clinical Outcomes Specialist to join our team. As a Clinical Outcomes Specialist, you will provide technical expertise in neurocognitive outcomes to support endpoint selection, modification, or development.Key Responsibilities:Provide expert guidance on...


  • San Diego, California, United States Sequel Medical Technology Full time

    About Sequel Medical TechnologySequel Med Tech is a pioneering company revolutionizing precision drug delivery devices. We strive to provide innovative solutions for people with diabetes.Job OverviewThe Senior Clinical Diabetes Specialist will collaborate with the Territory Business Leader to launch our cutting-edge insulin pump and future products in San...


  • San Francisco, California, United States The Stepping Stones Group Full time

    Job OverviewWe are seeking a dedicated Clinical Child Development Specialist to provide comprehensive psychological services in San Francisco, CA schools. This full-time position involves conducting assessments, counseling students, and collaborating with educators and parents to support academic and social-emotional growth.Key ResponsibilitiesConduct...


  • San Francisco, California, United States Levi Strauss & Co. Full time

    About the RoleThis position is a key part of our product development team, responsible for leading seasonal fit block development and executing fit intelligence to create best-in-class fits.As a Senior Garment Development Specialist, you will be working closely with designers to interpret their aesthetic requirements and translate them into styling details...


  • San Francisco, California, United States salesforce, inc. Full time

    We are seeking an experienced AI Software Developer to join our Hyperforce Developer Experience team at Salesforce, Inc. Located in a major metropolitan area, this role offers a competitive salary range of $180,000 - $250,000 per year.About the RoleAs a Senior AI Software Development Specialist, you will be responsible for designing and implementing...