- Collaborating on, or leading where appropriate, the preparation of clinical trial related documents including protocols, Investigator Brochure updates, charters, result presentations, and clinical sections of regulatory documents.
- Reviewing safety and efficacy data, data listings and preparing/ supporting data presentations.
- Rapid response to data or results questions from senior management.
- Participate in trial level activities for multiple trials including review of Clinical Operations documentation such as operational plans, data management plans, etc.
- Support safety/PV related activities including working with safety management vendor for safety monitoring and reporting activities.
- Support activities related to training of internal team, vendors, and site staff as required.
- Conduct literature reviews and contribute to competitive assessments for each therapeutic area.
- Collaborate on projects as necessary with other functions within Clinical as well as across project teams (Regulatory, Medical Writing, Medical Affairs, etc.).
- Proven ability to effectively support/contribute to multiple complex studies or projects.
- Effective written and spoken communication is essential.
- Adhere to SOPs, systems, and other process related training.
- Bachelor's degree in life sciences field is required; advanced degree (MS/PhD/PharmD, MD, etc.) is strongly preferred.
- Minimum of 5 years relevant Pharma or Biotech clinical drug development experience (PhI-IV) in a Clinical Scientist role. Urology clinical development experience strongly preferred, Oncology required.
- Experience in development of clinical documents to support regulatory submissions (eg, IND), clinical protocol/IB development, medical writing, literature reviews, data reviews and other similar clinical development projects.
- Knowledge of and experience applying the principles of clinical research methodology, statistics, data analysis and interpretation
- Proficiency in data review tools for data interpretation to both design/execute clinical trials and to extract data/prepare results for relevant clinical trials.
- Demonstrated evidence of writing clinical documents.
- Experience working with and managing third party vendors, such as CRO's
- Effective written and spoken communication skills are essential.
- Knowledge of FDA regulatory guidelines, drug development process and ICH/GCP is required.
- Knowledge of device global regulatory requirements such as 21 CFR 820, 21 CFR 4, 21 CFR 3.2, and ISO 13485 preferred.
- Strong project management skills and drive for excellence.
-
Principal Scientist, Oncology Research
2 days ago
Aktis Oncology Inc Boston, United States**Description**: · **Background/Training**: · - Ph.D. in biological sciences or related field, preferably related to oncology or cancer biology · - 2-8 years of biopharmaceutical research experience in drug discovery and/or translational research · **Experience/Accomplishments** ...
-
Aura Biosciences Inc. Brighton, United StatesAbout Aura: · At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion ...
-
Senior Scientist, Immuno-oncology
5 days ago
Flagship Pioneering, Inc. Cambridge, United StatesWhat if... you could join an organization that creates, resources, and builds life sciences companies that invent breakthrough technologies to transform human health and sustainability? · Flagship Pioneering's venture creation engine has conceived and created companies such as Mo ...
-
Senior Clinical Scientist, Oncology
1 week ago
BioSpace Cambridge, United StatesJob Details · The Role · This Senior Clinical Scientist role will support early/late phase Oncology Vaccine programs, specifically supporting the Study Physician executing phase 1-3 studies. · Heres What Youll Do:Support the Study Physician in the oversight of clinical studies in ...
-
Senior Clinical Scientist, Oncology
3 weeks ago
Moderna Theraputics Cambridge, United StatesThe Role · This Senior Clinical Scientist role will support early/late phase Oncology Vaccine programs, specifically supporting the Study Physician executing phase 1-3 studies. · Here's What You'll Do: · * Support the Study Physician in the oversight of clinical studies including ...
-
Senior Clinical Scientist, Oncology
3 weeks ago
Moderna, Inc. Cambridge, United States Full timeThe Role · This Senior Clinical Scientist role will support early/late phase Oncology Vaccine programs, specifically supporting the Study Physician executing phase 1-3 studies. · Heres What Youll Do: Support the Study Physician in the oversight of clinical studies including revi ...
-
In Vivo Sr Scientist, Oncology Research
5 days ago
AstraZeneca PLC Waltham, United StatesIn Vivo Sr Scientist, Oncology Research · Are you ready to make a difference in the world of oncology research & development? At AstraZeneca, we follow the science and turn ideas into life-changing medicines. If you have a passion for in vivo & in vitro experiments, we might be t ...
-
In vivo Senior Scientist Oncology Team
3 days ago
AstraZeneca Waltham, United StatesJob Description · In vivo Senior Scientist Oncology Team (Hematology) · Are you ready to redefine cancer and transform the lives of patients? At AstraZeneca Oncology R&D, we are pioneering a new approach to oncology. We are seeking an In vivo Senior Scientist to join our dynamic ...
-
Moderna, Inc. Cambridge, United States Full timeThe Role: · Moderna is seeking a highly motivated and experienced computational scientist with immunoinformatics background to join our collaborative, multi-disciplinary, and fast-paced team dedicated to the development of cancer immunotherapies. The primary focus of this role is ...
-
Moderna, Inc. Cambridge, United States Full timeThe Role: · Moderna is seeking a highly motivated and experienced computational scientist with immunoinformatics background to join our collaborative, multi-disciplinary, and fast-paced team dedicated to the development of cancer immunotherapies. The primary focus of this role is ...
-
Scientist, Oncology Bioinformatics, INT Omics
2 weeks ago
Moderna, Inc. Cambridge, United States Full timeThe Role: · Moderna is seeking a highly motivated bioinformatician with solid training in cancer genomics data analysis to work as part of a highly collaborative, multi-disciplinary, and fast-paced team. The primary focus for this position is to curate and evaluate cancer specifi ...
-
AstraZeneca PLC Waltham, United StatesSenior Scientist, Mass Spectrometry, Early Oncology · Join our Boston R&D chemistry team as a Senior Scientist, where you'll use your expertise in small-molecule mass spectrometry to analyze a wide range of drug-like small molecules, linkers, payloads, and new modalities using UH ...
-
AstraZeneca Waltham, United StatesJob Description · Senior Scientist, Mass Spectrometry, Early Oncology · Join our Boston R&D chemistry team as a Senior Scientist, where you'll use your expertise in small-molecule mass spectrometry to analyze a wide range of drug-like small molecules, linkers, payloads, and new ...
-
LASE Innovation Inc. Waltham, United StatesPrincipal Scientist, Immunology/Immuno-oncology Applications · Location: Waltham, MA · Company: LASE Innovation · About Us: · LASE Innovation is a cutting-edge, early-stage life-science tools startup dedicated to advancing the field of single-cell analysis through our pioneering ...
-
GlaxoSmithKline Waltham, United StatesSite Name: UK - Hertfordshire - Stevenage, Baar Onyx, GSK House, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence · Posted Date: Apr · This position will consider candidates at an Associate Director or Director level dependent on individual qualifications. · ...
-
AstraZeneca PLC Waltham, MA, United StatesSr. Scientist, Medicinal Chemistry, TTD, Early Oncology · Location: Waltham, MA, US · Do you want to be at the cutting edge of innovation that will lead to state-of-the-art therapies for cancer? At AstraZeneca, we turn ideas into life changing medicines. Our pioneering oncology p ...
-
AstraZeneca Waltham, United StatesJob Description · Are you a seasoned Early Clinical Scientist with experience in supporting Phase 1-2 studies? Do you have a keen interest in working across a variety of platforms such as IO, Antibody Drug Conjugates, Cell Therapy, Tumor Drivers and Resistance, Epigenetics and DN ...
-
AstraZeneca PLC Waltham, MA, United StatesAssociate Principal Scientist, Medicinal Chemistry, TTD, Early Oncology · Location: Waltham, MA, US · Do you want to be at the cutting edge of innovation that will lead to state-of-the-art therapies for cancer? At AstraZeneca, we turn ideas into life changing medicines. Our pione ...
-
AstraZeneca Waltham, MA, United StatesAssociate Principal Scientist, Medicinal Chemistry, TTD, Early Oncology · Location: Waltham, MA, US · Do you want to be at the cutting edge of innovation that will lead to state-of-the-art therapies for cancer? At AstraZeneca, we turn ideas into life changing medicines. Our pi ...
-
Scientist, Cmc Radiochemistry
3 weeks ago
Mariana Oncology Watertown, United States**Description**: · Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best-in-class alpha · - and beta-emitting radioligands that target cancer, while m ...
Assoc. Director/Director, Clinical Development Scientist-Urologic Oncology - Brighton, United States - Aura Biosciences
Description
Job Description
Job DescriptionSalary:About Aura:
At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.
We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs' broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.
Position Summary:
Aura Biosciences, Inc. is currently expanding its Clinical Development team to support several early- and late-phase clinical assets and is searching for a highly motivated and hands-on Associate Director/Director level Clinical Development Scientist to support the continued development of AU-011 in the treatment of ocular and non-ocular cancers. Aura is developing AU-011 as a biologic/drug-led combination product. This individual will be responsible for supporting the Medical Directors within the Clinical Development function, who are responsible for strategy, design, and oversight of all clinical programs at Aura.
Essential Functions and Duties:
Skills and Experience
