- Astellas Pharma (Northbrook, IL)
- …projects. + Position may require representing the company in negotiations on clinical studies with alliance partnerships, meetings with regulatory authorities ... GDPL, other project physicians, VP Global Medical Science and TA Head informed of clinical progress and...development programs. + Experience designing, implementing, conducting and reporting clinical studies , to produce both timely and… more
- AbbVie (San Francisco, CA)
- … Clinical Study Leadership organization, a global organization operating clinical studies in 60+ countries supporting all therapeutic area specific asset ... Instagram, YouTube and LinkedIn. Job Description The Sr. Director, Clinical Study Leadership, Therapeutic Area, oversees a...interventional clinical studies . + Establishes an appropriate framework… more
- J&J Family of Companies (Columbus, OH)
- …per those SOPs. + Ensure adequate, timely and compliant monitoring and management of clinical studies conducted in their TA . + Ensure that team ... management of a group Site Managers (SMs) in the Oncology Therapeutic Areas ( TA ) within GCO US...on an on-going basis. + Ensure the implementation of clinical studies through efficient allocation of LTMs,… more
- Kelly Services (West Point, PA)
- …+ Assists the CS Protocol Lead and study team with the clinical /scientific conduct of clinical studies eg, adjudication support, medical monitoring, ... and Clinical FSP is currently seeking a ** Clinical Scientist - Oncology ** for a long-term...( study sites, committees, etc.) in support of clinical study objectives **Minimum FTE Years of… more
- AbbVie (North Chicago, IL)
- …safety oversight (eg surveillance, signal detection, validation, and assessment) for early oncology products with a proactive approach to clinical safety, and ... / Clinical Development experience in the pharmaceutical industry + Oncology experience and early development experience strongly preferred + Effectively analyze… more
- Astellas Pharma (Northbrook, IL)
- …Core Medical Plan (CMP) + Accountable for oversight and execution of MA-sponsored clinical studies , as applicable + Drive scientific and medical development and ... **Medical Director Oncology , Medical Affairs** Do you want to be...reports, including health economic & outcomes research (HEOR) related studies , ensuring clinical and scientific accuracy +… more
- IQVIA (Wayne, PA)
- …regulatory requirements, in alignment with the organizational and therapeutic area ( TA ) Clinical Team (CT)'s objectives. Services/deliverables include the global ... alignment with and communication to the involved stakeholders, including TA and feasibility leads. * Develops the trial ESP...to the trial team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical … more
- Gilead Sciences, Inc. (Foster City, CA)
- …drug classes to align and build an integrated publication strategy and plans for global clinical studies from Phase I (in humans studies ) and non- clinical ... are seeking a dynamic Senior Director of Scientific Publications with a focus on Oncology to lead our scientific publication team. The ideal candidate will have a… more
- J&J Family of Companies (Columbus, OH)
- …Research group also covers disease biology for the indications of interest for the Oncology TA . The Senior Scientific Director will also be responsible for: + ... Clinical protocols, Investigator Brochures, Compound Development Plans generation of Clinical Study Report + Managing the outstanding or in-house… more
- Gilead Sciences, Inc. (Foster City, CA)
- …support implementation of the strategic Oncology publication plans for global clinical studies and non- clinical sources, including HEOR, Epidemiology, ... RWE, Payer, Non-interventional, and database studies , to demonstrate the value of pipeline and inline...Global Publication Plan (GPP) for one or more Gilead Oncology products/indications in collaboration with Clinical Research,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …RMPs, etc.) and the review of clinical documents (Investigator Brochures, protocols, clinical study reports, etc.) **A typical day in this role might include ... issues for the compound(s) [asset(s)] assigned within the Solid Oncology therapeutic area ( TA ), and is the...medical field with PharmD / PhD / degree + Clinical experience and/or industry experience in the TA… more
- AbbVie (Mettawa, IL)
- …other applicable local regulations + Good understanding of Medical Affairs principles, study design and publications. + Knowledge of clinical trial methodology, ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (Mettawa, IL)
- …and procedures. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
- AbbVie (Mettawa, IL)
- …remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our ... Area offices. The Director, Health Economics & Outcomes Research (HEOR) Strategy, Oncology leads the strategy development and project execution for on-market and/or… more
- Boehringer Ingelheim (Ridgefield, CT)
- …products within a therapeutic area, including use of innovative methods and study designs. Generate value evidence proactively to support brand value propositions, ... US HEOR perspectives and payer/organized provider evidence requirements into Phase II/III clinical development programs and Phase IV (PMO) programs to maximize the… more
- Boehringer Ingelheim (Ridgefield, CT)
- … **Description** The AD/Sr. AD, Regional Marketing - Oncology leads and coordinates the development, implementation, and monitoring ... and opportunities. + Collaborates with and provides input to market research on study design and interpret findings to refine product marketing direction. + Promotes… more
- Merck (Rahway, NJ)
- …+ Address operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide. + Lead ... This position focuses on strategic activities impacting late-stage development therapeutic area ( TA ) projects to the direct benefit of project teams and the… more
- J&J Family of Companies (Spring House, PA)
- …in the start-up and day to day management of one or more global clinical studies , in compliance with department safety practices, policies, and procedures * ... disease evaluation criteria, or other specific aspects of the clinical study * Participate and lead aspects... and Cross Functional Trial teams * Members of Oncology TA Contacts outside the Company: *… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and vendors. **Responsibilities** ** Study Planning** : Plans and designs studies consistently with product development and clinical development plans. ... are the plan, design, and conductance of early development clinical studies ; the preparation of regulatory documents...selecting clinical and mechanistic endpoints. Act as clinical study leader. ** Study Execution:**… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …within an indication or project; Attends EOP2 meeting and represents clinical /TMCP + Study Planning and Execution: Clinical Study Lead (CSL) for large ... and decision-making process cross-functionally and cross-regionally; Facilitate team coordination + Study outputs: For Phase 3 studies : Drafts responses to… more