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Clinical Scientist
1 month ago
IGI is an alliance between Ichnos Sciences Inc., a clinical-stage biotech company developing multispecifics™ in oncology, and its parent, Glenmark Pharmaceuticals Limited (Glenmark), with the aim to accelerate new drug discovery in cancer treatment.
Our vision
Daring to imagine a world where a cure is possible. Moving beyond hope, with therapies that will forever transform medicine and lives.
Our mission
To co-create innovative treatment solutions that make healthier living possible.
Designation: Clinical Scientist – Associate Director
Reporting to: Senior Medical Director
Role Overview / Purpose
As an experienced Clinical Scientist, you will provide scientific leadership in the innovative design, execution, and interpretation of clinical trials in one or more development programs. The role will close collaboration with the Medical Directors and the Chief Medical Officer and with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups. Your expert scientific input will be crucial in the preparation of regulatory documents and interactions with regulatory authorities. You will also lead the development of quality metrics and data review plans for assigned studies, support and contribute to medical monitoring of trials, and ensure scientific input to TA standards.
Job Responsibilities
- Advanced knowledge of the therapeutic area of malignant hematology and oncology (preferably in Multiple Myeloma).
- Lead or co-lead development of a trial protocol and other study-related and regulatory documents, case report forms (eCRFs), eCRFs completion guidelines, database lock activities, and medical data review plan.
- Perform ongoing data review, summarize efficacy and safety data for interpretation/analysis, prepare and present to internal/external committee meetings (ie, Dose Escalation Committee, Steering Committee, Safety Committees, Investigator meetings, CRO/CRA training, SIVs).
- Participates in country/site selection, and feasibility assessment and engages in KOL interaction.
- Authority in scientific literature searches and weighing of quality peer-reviewed data.
- Ability to manage trials
- May support operational activities if required up to 30%.
Key Relationships / Stakeholders
Experience interacting with varying levels of internal/external management, Investigators and site personnel, clinicians, scientists, and cross-functional teams.
Knowledge and Skills (Functional / Technical)
- Experience providing scientific support for the development and implementation of oncology studies, including protocol and ICF development, electronic data capture database development, safety assessment, IB/DSUR submissions, and support for journal and conference publications.
Educational Qualifications
- Advanced scientific degree (M.S., Ph.D., Pharm D., MPH, MD, or equivalent degree) with 7 plus years of industry experience in clinical development.
- Experience designing and driving industry-sponsored clinical trials in clinical development roles.
- Broad understanding of the principles of clinical trial methodology, statistics, data analysis, and interpretation.
Behavioral Attributes
- Ability to communicate with internal and external partners.
- Strong leadership skills; Always maintain a positive & professional self-representation & on behalf of the company to external and internal partners.
- A professional willing to adapt to the business needs in a small biotech setting.
There is no relocation being offered at this time. The role is hybrid, 3x in the NYC office.
Ichnos Sciences Inc. and IGI are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, height, weight, protected veteran status, or any other characteristic protected by law.
** DIRECT HIRE ONLY. OUTSIDE RECRUITERS & RECRUITING AGENCIES ARE NOT BEING EMPLOYED BY ICHNOS SCIENCES INC or IGI TO FILL THIS POSITION. **
