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Scientific director cta program Jobs

95 Jobs

  • 4.4
    Acceleron Pharma – Cambridge, MA
    $176k-$237k(Glassdoor est.)
    HOT
    and preparation of global regulatory submissions (eg, INDs, CTAs, meeting requests, pediatric investigation plans, responses to… development plans for assigned projects Maintain active INDs/CTAs (amendments and annual reports) Develop and maintain regulatory…
  • 3.6
    Moderna Therapeutics – Cambridge, MA
    NEW
    direct experience leading the delivery of an IND or CTA. Strong scientific research background in areas of focus; experience in… teams and medical/scientific communities Highly developed understanding of the external market place and scientific literature to…
  • 3.6
    Moderna Therapeutics – Cambridge, MA
    NEW
    direct experience leading the delivery of an IND or CTA. Strong scientific research background in areas of focus; experience in… its metabolic rare diseases development programs. This role will report to the Sr. Director, Clinical Development, Rare Diseases,…
  • 3.8
    Celgene Corporation – Summit, NJ
    $174k-$272k(Glassdoor est.)
    NEW
    timeless of clinical sections of INDs, Investigator Brochures, CTAs , ISS, ISEs and clinical expert reports. Represent the team… limited to, the following: Provide therapy area medical and scientific expertise to study teams and key stakeholders. Lead the development…
  • 3.7
    Amgen – Thousand Oaks, CA
    $177k-$278k(Glassdoor est.)
    5 days ago 5d
    support of preclinical and clinical programs. Medical Sciences is looking for a strong scientific leader in the cardio-metabolic… responsible for providing scientific/ medical direction and leadership for pre-clinical/ early clinical programs for Amgen's early development…
  • 2.7
    Eisai Inc. – Woodcliff Lake, NJ
    $137k-$223k(Glassdoor est.)
    HOT
    of the IND/NDA/CTA/MAA processes acquired through direct industrial experience Knowledge of medical, scientific and clinical research… IND/NDA/CTA/MAA processes acquired through direct industrial experience Knowledge of medical, scientific and clinical…
  • 3.8
    Celgene – Summit, NJ
    $174k-$272k(Glassdoor est.)
    NEW
    timeless of clinical sections of INDs, Investigator Brochures, CTAs , ISS, ISEs and clinical expert reports. Represent the team… limited to, the following: Provide therapy area medical and scientific expertise to study teams and key stakeholders. Lead the development…
  • 4.1
    Fairway Consulting Group – United States
    12 days ago 12d
    clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS… interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents. This person must have strong…
  • 3.3
    Intarcia Therapeutics, Inc. – Hayward, CA
    $122k-$287k(Glassdoor est.)
    18 days ago 18d
    IND, CTA/NDA/MAA) Strong interpersonal, communication, and leadership skills Ability to review regulatory and scientific submission… strategies for program and leading the preparation and submission of regulatory documentation including IND, CTA, NDA and MAA.…
  • 5.0
    Xencor – San Diego, CA
    $90k-$144k(Glassdoor est.)
    NEW
    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…
  • 3.4
    Dairy Management – Rosemont, IL
    21 days ago 21d
    DirectorScientific Affairs CLICK HERE TO APPLY The Dairy community’s health and sustainability commitment has a broad… outreach and education programs for priority topics: Create and execute scientific symposia at key scientific meetings – from…
  • 3.3
    Intarcia Therapeutics, Inc. – Boston, MA
    $192k-$301k(Glassdoor est.)
    HOT
    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…
  • 3.6
    ICONMA – Woodcliff Lake, NJ
    Today 3hr
    of the IND/NDA/CTA/MAA processes acquired through direct industrial experience Knowledge of medical, scientific and clinical research… and liaising with key opinion leaders regarding program strategy and scientific advice interpreting study data and developing…
  • 3.8
    Integrated Resources – Woodcliff Lake, NJ
    Today 3hr
    of the IND/NDA/CTA/MAA processes acquired through direct industrial experience Knowledge of medical, scientific and clinical research… and liaising with key opinion leaders regarding program strategy and scientific advice interpreting study data and developing…
  • 3.2
    Mitsubishi Tanabe Pharma – Jersey City, NJ
    $165k-$221k(Glassdoor est.)
    NEW
    reviews and leads preparation of IMPD to support international CTA submissions oversees preparation of regulatory submissions… team members. Bachelors or Masters Degree in a scientific discipline or equivalent. Strongly preferred: PhD or PharmD…
  • 4.7
    Information Technology & Healthcare Staffing – San Rafael, CA
    $101k-$199k(Glassdoor est.)
    4 days ago 4d
    regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments… biologic drug candidates. This individual will provide scientific leadership and play a pivotal role from late-stage research…
  • 4.4
    Acceleron Pharma – Cambridge, MA
    $84k-$185k(Glassdoor est.)
    6 days ago 6d
    of a Bachelor’s Degree in a scientific discipline or equivalent Experience with biologics program from development through registration… reviewing CMC sections of regulatory submissions (INDs, IMPDs, CTAs, BLAs, MAAs, etc.) Knowledge of: drug development; FDA, EMA…
  • 3.2
    Mitsubishi Tanabe Pharma – Jersey City, NJ
    $136k-$221k(Glassdoor est.)
    NEW
    supporting the development and writing of regulatory documents (IB/IND/CTA), study protocols and clinical development plans. The role will… and comfortable supporting the writing of sections from IB/IND/CTA or other regulatory dossiers as needed Good understanding of…
  • 3.0
    Maxisit – Woodcliff Lake, NJ
    Today 6hr
    of the IND/NDA/CTA/MAA processes acquired through direct industrial experience Knowledge of medical, scientific and clinical research… and liaising with key opinion leaders regarding program strategy and scientific advice interpreting study data and developing…
  • 4.1
    Fairway Consulting Group – United States
    4 days ago 4d
    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…
  • 3.7
    Celldex Therapeutics – Needham, MA
    $105k-$222k(Glassdoor est.)
    NEW
    Overview The Director / Senior Director, Regulatory Affairs will support Celldex's development programs by defining and implementing… clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) and serve as primary liaison with regulatory authorities…
  • 4.1
    Fairway Consulting Group – United States
    4 days ago 4d
    efficient, high quality therapeutic development programs, based on the highest scientific, medical, and regulatory standards. Accountability… study reports, clinical sections of regulatory submissions (IND, CTA, and CTD). Oversight of key leaders involved in the management…
  • 4.1
    Fairway Consulting Group – United States
    4 days ago 4d
    Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies… and scientific awareness in area of expertise. Ensures Clinical Research consultants are kept fully informed of programs and…
  • 4.1
    Fairway Consulting Group – United States
    4 days ago 4d
    quality prophylactic and therapeutic development programs, based on the highest scientific, medical, and regulatory standards. Accountability… reports, and clinical sections of regulatory submissions (IND, CTA, and CTD). Medical monitoring of clinical research studies.…
  • 4.1
    Fairway Consulting Group – Remote, OR
    5 days ago 5d
    compliance practices. Provides scientific and clinical expertise to a clinical development program and clinical strategies for a… III and international regulatory submissions in terms of INDs, CTAs, End-of-Phase 2 meetings and NDAs/BLAs/MAAs is needed. Must…
  • 4.1
    Fairway Consulting Group – United States
    4 days ago 4d
    including: INDs, IND amendments, clinical trial applications (CTAs), NDA, sNDA, etc. Develops submission materials for local HA… HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness…
  • 3.8
    Planet Pharma – Newark, CA
    $176k-$280k(Glassdoor est.)
    7 days ago 7d
    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…
  • 3.3
    Sucampo Pharmaceuticals, Inc. – Rockville, MD
    $94k-$198k(Glassdoor est.)
    5 days ago 5d
    submission andmaintenance of DMEs, DMFs, NDAs, sNDAs, INDs, CTAs to the FDA and other globalregulatory authorities. Review and… Pharmaceuticals, Inc. (SPI)is currently searching for a Director/ Senior Director, Regulatory Affairs for the US office locatedin Rockville…
  • 3.6
    PRA Health Sciences – United States
    $114k-$154k(Glassdoor est.)
    NEW
    strategy, due diligence, regulatory scientific review of regulatory submissions - NDA/BLA, IND, MAA, CTA, CTD, NDS submissions etc. Leads… Overview The Director, Global Regulatory Affairs provides scientific and related regulatory expertise regarding preclinical…
  • 3.7
    Pfizer – New York, NY
    5 days ago 5d
    responses to regulatory queries and audit/inspection findings, CTAs, and submission documents by providing relevant clinical support… Clinician - Oncology, MD is accountable for the medical &; scientific integrity of the study or studies and the well-being of the…
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