Principal Clinical Research Scientist

Location
USA, USA
Posted
Jul 10, 2021
Ref
311709
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics. Our proprietary biologic drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases. MTEM currently has multiple clinical-stage ETB candidates in development including MT-5111, TAK-169, and MT-6402. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Under the direction of the Clinical Development Director, the Principal Clinical Research Scientist will provide active scientific contribution to cross-functional teams to advance Molecular Template's clinical programs and oversee and develop clinical projects. The Principal Clinical Scientist provides input to the clinical development plans, is a key contributor to the development of the clinical trial protocols and related documents, takes responsibility for coordinating completion of clinical study reports, and supports preparation of relevant documents for regulatory filings (annual reports and IBs). The Principal Clinical Research Scientist will collaborate with Study Physician(s) in monitoring of clinical trial data and conduct. Qualified candidates must possess comprehensive knowledge of clinical trial design and conduct in accordance with ICH/GCP and other related regulations or guidelines, particularly in the therapeutic area of oncology. This requires a good understanding of clinical and medical information related to oncology, as well as excellent organizational, project management, data review and time-management skills.

Job Responsibilities:
  • Key contributor to protocols, amendments, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents
  • In collaboration with Trial Statistician, support development of Statistical Analysis Plans and data shells
  • Responsible to support development of and implementation of relevant data capture tools in collaboration with data and trial manager(s) and CRO (e.g. CRFs, protocol deviations, edit checks, UAT)
  • Responsible for performing the ongoing review of clinical trial data as outlined in the data review plans or equivalent
  • Support trial managers to prepare database lock and perform ongoing data review and reconciliation during trials
  • Responsible for providing scientific training and required materials (SIV slides) to study managers and study staff
  • Collaborate with Study Physician(s) to identify safety trends and, as needed, reports on trial data to safety and clinical boards
  • In collaboration with Study Physician(s), responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications, and internal/external presentations
  • Assist with drafting responses to questions from ethics committees and health authorities
  • Review medical literature and related new technologies
  • May be asked to assess/co-author medical publications
  • Act independently to determine methods and procedures on new assignments
  • May oversee and manage the activities of junior level scientists

Qualifications:
  • PhD in Life Sciences or PharmD, required
  • Minimum of eight (8) years of experience in clinical development, preferably in oncology
  • Demonstrated success in technical proficiency, scientific creativity, collaboration with others
  • Comprehensive practical knowledge of the development of study protocols and conduct and reporting of clinical studies in accordance with ICH/GCP and other related regulations or guidelines
  • Extensive experience with database development, design of data collection tools, data review and querying
  • Possess awareness of global regulatory and pharmacovigilance environments
  • Experience of successful work in cross-functional project or study team matrix
  • Experience in coordinating collaboration with and training of investigative centers, clinical staff and CROs is required
  • Demonstrated proficiency in independent data analysis skills
  • Excellent written and verbal communication skills in English are required
  • Excellent organizational, project management and time-management skills
  • Proficiency with all Office Suite tools (MS Word, Excel, PPT, Project)
  • Ability to function independently and exercise good judgement


Reporting Structure:

This position may oversee and manage the activities of junior level scientists, but the primary role will be as an individual contributor. This position will report to the Senior Director, Clinical Development.

Molecular Templates celebrates and supports our differences and is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic.

MTEM is committed to providing reasonable accommodations for qualified individuals. If you need assistance with your application due to a disability, you may contact us at: careers@mtem.com.

By submitting a resume for consideration, applicants verify that they have read MTEM's Applicant Privacy notice. https://www.mtem.com/privacy-policy

Molecular Templates Inc https://mtem.isolvedhire.com