Senior Clinical Scientist

1 week ago

New York, New York, United States Ichnos Glenmark Innovation Full time

About Ichnos Glenmark Innovation:

Ichnos Glenmark Innovation is a collaboration between Ichnos Sciences Inc., a clinical-stage biotechnology firm focused on developing multispecific therapeutics in oncology, and Glenmark Pharmaceuticals Limited, its parent company. Our mission is to expedite the discovery of novel treatments for cancer.

Vision:

We dare to envision a future where cures are attainable, transcending mere hope with transformative therapies that can change the landscape of medicine and improve lives.

Mission:

We aim to co-create pioneering treatment solutions that facilitate healthier living.

Role Overview:

As a seasoned Clinical Scientist, you will play a pivotal role in providing scientific direction for the innovative design, execution, and analysis of clinical trials across various development programs. This position requires close collaboration with Medical Directors, the Chief Medical Officer, and other team members, including Study Physicians, Patient Safety experts, Regulatory Affairs, Clinical Operations, Translational teams, CMC, and early development groups. Your scientific expertise will be vital in preparing regulatory documents and engaging with regulatory bodies. Additionally, you will spearhead the development of quality metrics and data review plans for assigned studies, contribute to medical monitoring of trials, and ensure scientific input into therapeutic area standards.

Key Responsibilities:

  • Lead or co-lead the creation of trial protocols and other study-related and regulatory documents, including electronic case report forms (eCRFs), completion guidelines, database lock activities, and medical data review plans.
  • Conduct ongoing data reviews, summarize efficacy and safety data for interpretation and analysis, and prepare presentations for internal and external committee meetings.
  • Engage in country/site selection and feasibility assessments, and interact with key opinion leaders (KOLs).
  • Demonstrate authority in conducting scientific literature searches and evaluating quality peer-reviewed data.
  • Manage clinical trials effectively.
  • Support operational activities as needed, up to 30% of the time.

Key Relationships / Stakeholders:

Experience in interacting with various levels of internal and external management, investigators, site personnel, clinicians, scientists, and cross-functional teams is essential.

Educational Qualifications:

An advanced scientific degree (M.S., Ph.D., Pharm D., MPH, MD, or equivalent) with over 7 years of industry experience in clinical development is required.

Experience:

Proven experience in designing and leading industry-sponsored clinical trials in clinical development roles is essential.

A comprehensive understanding of clinical trial methodology, statistics, data analysis, and interpretation is necessary.

Knowledge and Skills:

Advanced knowledge of malignant hematology and oncology, particularly in Multiple Myeloma, is preferred.

Experience in providing scientific support for the development and execution of oncology studies, including protocol and informed consent form (ICF) development, electronic data capture database creation, safety assessments, and submissions for investigational brochures and development safety update reports.

Behavioral Attributes:

  • Excellent communication skills with internal and external partners.
  • Strong leadership capabilities; consistently represent the company positively and professionally to all stakeholders.
  • A flexible approach, willing to adapt to the evolving needs of a small biotech environment.

This is an exempt position and is not eligible for overtime compensation. The base salary range for this role is competitive. This position offers a hybrid work model.

Ichnos Sciences, Inc. & Ichnos Glenmark Innovation are equal opportunity employers. 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.

Note: This position is a direct hire opportunity. External recruiters and recruiting agencies are not being utilized for this role.

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