Scientific director cta program Jobs | Glassdoor

Scientific director cta program Jobs

140 Jobs
Filters
Filters
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $143k-$197k
    3 days ago 3d
    experience (IND, CTA) Strong interpersonal, communication, and leadership skills Ability to review regulatory and scientific submission… and creation of all required submission documents to IND and CTA Develop and implement creative regulatory strategies aimed…
  • 3.7
    bluebird bio – Cambridge, MA
    4 days ago 4d
    Coordinate the Quality review of all regulatory filings (IND, CTA, DSUR, BLA, MAA, Annual Reports) to ensure accuracy and consistency… Regulatory Affairs. Bachelors and/or Masters degree in scientific discipline with a technical understanding of biopharmaceutical…
  • 3.8
    Fairway Consulting Group – United States
    3 days ago 3d
    efficient, high quality therapeutic development programs, based on rigorous scientific, medical, and regulatory standards. Accountability… reports, and clinical sections of regulatory submissions (IND, CTA, and CTD). Medical monitoring of clinical research studies.…
  • Epizyme – Cambridge, MA
    Est. Salary $50k-$116k
    Today 10hr
    culture of transparency, intensity, scientific rigor, and fun! The Associate Director of Toxicology reports to the Head of… applications of programs and systems to lead processes in a new direction. Provides scientific leadership for one or more programs. Responsibilities…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $51k-$100k
    26 days ago 26d
    accountability for PS deliverables. Provides strategic scientific leadership and program management for multiple global PS development… preparation of the PS sections of global regulatory submissions (e.g. CTAs and commercial applications) and PS responses to regulatory agencies…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $102k-$239k
    18 days ago 18d
    strategies for program and leading the preparation and submission of regulatory documentation including IND, CTA, NDA and MAA.… documentation, including investigational and marketing applications (IND, CTA, NDA, MAA etc.) in compliance with global regulatory agency requirements…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    26 days ago 26d
    OBJECTIVES: The Associate Scientific Director manages strategic, scientific and operational aspects of programs from the clinical pharmacology… Responsible for clinical pharmacology summary documents (such as IB, CTA). Performs PK/PD analyses or guides such analyses as appropriate…
  • 3.7
    Florida Hospital – Maitland, FL
    Est. Salary $49k-$81k
    Today 4hr
    Sponsored Programs (OSP), a central office reporting to the Vice President of Research Operations and the Chief Scientific Officer… Confidential Disclosure Agreements (CDAs) Clinical Trial Agreements (CTAs) Incoming and Outgoing Research and Funding Support Agreements…
  • 3.7
    Global Drug Development – Cambridge, MA
    11 days ago 11d
    IND/CTA submissions and approval. Leadership role in HA negotiations in multiple regions, particularly for early programs. Working… with the TA DRA representatives to assure a well defined IND/CTA submission planning process for first in human and other early…
  • 3.7
    Adventist Health System – United States
    Est. Salary $42k-$70k
    Today 5hr
    Sponsored Programs (OSP), a central office reporting to the Vice President of Research Operations and the Chief Scientific Officer… Confidential Disclosure Agreements (CDAs) Clinical Trial Agreements (CTAs) Incoming and Outgoing Research and Funding Support Agreements…
  • 2.9
    CSL Behring – King of Prussia, PA
    Est. Salary $63k-$116k
    6 days ago 6d
    aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle… The Global Clinical Program Director (CPD) is a key role within Clinical Development responsible for global implementation of…
  • 2.6
    FibroGen – San Francisco, CA
    Est. Salary $141k-$290k
    16 days ago 16d
    maintenance of IND or CTA filings. Oversee development of all regulatory filings in support of program •In collaboration with… documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness…
  • 4.2
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $119k-$208k
    18 days ago 18d
    Assure necessary QA review of regulatory submissions for IND’s, CTA’s, NDA’s, etc. as assigned. Assists with talent recruitment… Bachelor’s degree in a scientific or health-related field required. Master’s degree in a scientific or health-related field…
  • 5.0
    Blueprint Medicines – Cambridge, MA
    Est. Salary $185k-$294k
    24 days ago 24d
    , including Investigator’s Brochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from… the company both internally and externally, including the scientific community and key opinion leaders Qualifications…
  • 4.1
    University of Pennsylvania – Philadelphia, PA
    Est. Salary $78k-$119k
    6 days ago 6d
    development from pre-IND/IDE/CTA to NDA/BLA/PMA/510k required; Experience in academia or industry in scientific discovery and pre-clinical… and Devices (IDEs) foreign clinical trial applications (CTAs). The Director is charged with the development and execution of the…
  • 2.9
    CSL Behring – King of Prussia, PA
    Est. Salary $63k-$116k
    14 days ago 14d
    research program design meets scientific objectives and is aligned with commercial needs. Serves as medical/scientific consultant… aspects of regulatory strategy in support of the filing of INDs/CTAs and license applications throughout the development lifecycle…
  • Protagonist Therapeutics – Milpitas, CA
    5 days ago 5d
    such as for IND, CTAs BLAs, NDAs/MAAs filings and pre-IND briefing book preparations. Works closely with Program Management, Clinical… agencies, major scientific meetings, advisory boards, and corporate meetings. Evidence of publication of original scientific papers in…
  • 3.4
    Celgene Corporation – Summit, NJ
    Est. Salary $172k-$273k
    5 days ago 5d
    timeless of clinical sections of INDs, Investigator Brochures, CTAs, ISS, ISEs and clinical expert reports. • Represent the team… RESPONSIBILITIES: • Provide therapy area medical and scientific expertise to study teams and key stakeholders. • Lead the…
  • 3.7
    Global Drug Development – Cambridge, MA
    6 days ago 6d
    The Oncology Precision Medicine Director is responsible for directing the strategic and scientific aspects of biomarker and IVD development… identification and validation of external laboratories involved in CTAs for IO clinical trials and companion diagnostic development.…
  • NIBRI – Cambridge, MA
    6 days ago 6d
    The Oncology Precision Medicine Director is responsible for directing the strategic and scientific aspects of biomarker and IVD development… identification and validation of external laboratories involved in CTAs for IO clinical trials and companion diagnostic development.…
  • 3.4
    Celgene – Summit, NJ
    Est. Salary $172k-$273k
    5 days ago 5d
    timeless of clinical sections of IND’s, Investigator Brochures, CTA’s, ISS’, ISE’s and clinical expert reports. • Represent the team… Medical Director, Clinical Research & Development – CAR-T Programs Req #: 16002106 Location: Summit, NJ US…
  • Epizyme – Cambridge, MA
    Est. Salary $93k-$197k
    4 days ago 4d
    join our culture of transparency, intensity, scientific rigor, and fun! The Director of Regulatory Affairs will be responsible… development of simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages…
  • 3.3
    Ultragenyx Pharmaceutical Inc. – Novato, CA
    Est. Salary $151k-$207k
    5 days ago 5d
    submissions • Manage, mentor and develop direct reports • Manage IND/CTAs, BLA/MAA/NDS, annual reports, and information amendments in multiple… that allows for sufficient knowledge in this area • Strong scientific background with at least seven (7) years of experience in…
  • 3.6
    Novartis – Cambridge, MA
    6 days ago 6d
    The Oncology Precision Medicine Director is responsible for directing the strategic and scientific aspects of biomarker and IVD development… identification and validation of external laboratories involved in CTAs for IO clinical trials and companion diagnostic development.…
  • 3.8
    Fairway Consulting Group – United States
    3 days ago 3d
    amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring… especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP…
  • 2.7
    Selecta Biosciences – Watertown, MA
    Est. Salary $102k-$219k
    24 days ago 24d
    a career enhancing opportunity to lead rare disease programs from IND/ CTA filing to launch and participate in all critical steps… projectsEducation/Training/Experience • Bachelors degree in a scientific discipline. PhD or MBA preferred but not essential, additional…
  • 3.4
    Genomic Health, Inc. – San Mateo, CA
    Est. Salary $153k-$226k
    4 days ago 4d
    responsibilities for junior level CTMs and/or Clinical Trial Assistants (CTA). You will have core responsibilities in Design Control as it… Lead study and clinical team meetings; provide direction to CTAs to coordinate study and team meeting details; With study team…
  • 2.4
    Intarcia Therapeutics – Boston, MA
    Est. Salary $166k-$265k
    26 days ago 26d
    and amendments, ICFs, IBs, clinical research reports, INDs, CTAs). Works with the Global Patient Safety Head to develop the… information for individual cases. Participate in review of scientific literature: identify case reports that meet criteria for entry…
  • 2.7
    Eisai – A Country Place, NJ
    Est. Salary $110k-$184k
    10 days ago 10d
    of the IND/NDA/CTA/MAA processes acquired through direct industrial experience • Knowledge of medical, scientific and clinical… and liaising with key opinion leaders regarding program strategy and scientific advice - interpreting study data and developing…
  • Xencor – Monrovia, CA
    Est. Salary $126k-$186k
    2 days ago 2d
    from each other scientific rigor, a passion for innovation, and a willingness to take risks. We seek a Director Clinical Operations… and timelines for milestone deliverables generated by CTM/CRA/CTA (eg. subject tracking reports, biological sample management reports…
Page 1 of 5
Be the first to get new jobs like these: