- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Data Management (CDM) serves as Therapeutic Area Head providing Clinical Data Management leadership to Data ... support of Regeneron key development programs. Works with Sr Director and Executive Director to set department...Manager (CCDM) experience. + Minimum of 12+ years of clinical data management experience in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for ... Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with… more
- Lilly (Branchburg, NJ)
- …$111,000 - $162,800 **Position Description:** The Clinical Trial (CT) Supply Management Associate Director will provide operational leadership of clinical ... and mitigate risk, and perform portfolio analyses through robust data and metrics analysis + Lead and ensure operational...At least 5 years work experience in supply chain management or clinical development **Additional Preferences:** +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part ... The Director Clinical Sciences, Hematology, leads in... data review + Ensures consistent first line medical/ clinical data review techniques and conventions across… more
- AbbVie (Florham Park, NJ)
- …the people within their organization. + Provide leadership and direction to the Clinical Data Management Operations team, ensuring alignment with ... operational model is exemplified through execution and innovation. The Director of Clinical Data Strategy...resource allocation, and timelines to ensure successful execution of clinical data management activities. +… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management 5. Work with Biometrics to ... will monitor clinical studies, review and interpret clinical trial data , provide input into ...veteran status, disability or any other legally protected status. Director Clinical Development - Base Salary range… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development - Respiratory Date: Dec 17, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 59023 ... new people to make a difference with. **The opportunity** Director , Clinical Development is responsible for the... Development is responsible for the development, execution and management of several clinical programs worldwide across… more
- The Cigna Group (Morris Plains, NJ)
- …methodologies, data governance frameworks, and regulatory requirements. Proficiency in data management tools and platforms (eg, SQL, Python, R, Hadoop, ... **Managing Director , Enterprise Data Governance and Strategy**...Team (SLT). _Key Responsibilities:_ + Provide strategic leadership and management of the Enterprise Data Governance and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Stryker (Mahwah, NJ)
- … plan, and final study report. Oversee the authorship the trial Safety Plan, Clinical Events Committee Charter, Data Management Committee Charter. Supervise ... focus of role is to maximize the leverage of clinical data generated by Stryker-sponsored research, Investigator...include: + All processes utilized by the Biostatistics and Data Management organization related to trial database… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review + Conducts clinical data review per Integrated Data Review Plan (IDRP) + ... ** Director , Clinical Development** **Join a Legacy...(MM): + Provides oversight to the CRO MM for clinical data review activities + May support… more
- Bristol Myers Squibb (Summit, NJ)
- …and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data ... for the** Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis, interpretation, and reporting… more
- Actalent (Basking Ridge, NJ)
- Job Title: Director , Clinical SafetyJob Description The Director , Clinical Safety will be responsible for leading overall product safety strategy, safety ... management . This role involves providing safety leadership across clinical studies, post-marketing surveillance, signal detection, and regulatory submissions. The… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** Job Description **Associate Director , Clinical Pharmacology - Oncology** **_*This is a site-based ... cross-functional study team. + With input from others, designs clinical pharmacology study protocols, study data analysis,... pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific… more
- Sanofi Group (Swiftwater, PA)
- **Job title: Director Non- clinical Biostatistics - Vaccines** + Location: Swiftwater, PA or Waltham, MA (must have ability to work onsite 2-3 days per week per ... Join our Translational and Nonclinical Biostatistics team in Sanofi Vaccines as the ** Director of Non- clinical Biostatistics** where you will lead a team of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...+ Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …supplier management activities, and stakeholder engagement activities for the Clinical Laboratories Category as assigned. + Works independently to drive value in ... Accountabilities:** + Accountable for leading, defining, and implementing the global Clinical Laboratories Category strategy to serve global and regional business… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Dec 28, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... and new people to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership,… more
- Sanofi Group (Bridgewater, NJ)
- …on patients' lives. **Main responsibilities:** As a Senior Statistical Project Leader ( Director ) in our Statistical Innovation Hub, you will serve as the expert ... for defining novel digital endpoints or re-engineering existing endpoints from digital Clinical Outcome Assessments (COAs). You will act as a go-to person in… more
- IQVIA (Bridgewater, NJ)
- …directed at decision-makers and decision influencers at existing and new clinical sponsors. Essential Functions + Actively prospect and leverage potential new ... CRM system. + Prepare sales activity report for Sales Management as required. + Serve as a liaison between...Excellent analytical skills in assessing and interpreting customer business data + Ability to maintain demanding timelines. + Ability… more