About Cartography Biosciences

Cartography Biosciences is a therapeutics organization creating the first atlas to identify targets that are specific enough to only engage cancerous cells, broad enough to work across cancer cells and patients, and safe enough to sidestep toxic side effects. Founded by Kevin Parker, Howard Chang, and Ansu Satpathy, Cartography is bridging immunology and computation to understand the critical differences between normal and cancerous cells, ultimately solving the challenge of finding the safest, most selective targets for a variety of immunotherapeutic approaches. 

About the role

The Senior Director, Clinical Science plays a crucial role in the clinical development of the novel drug candidates in the company’s portfolio. The Senior Director, Clinical Science will make important contributions to the planning, execution, and analysis of clinical trials to ensure the safety and efficacy of the new treatments. The Senior Director, Clinical Science will be reporting to the CMO. The Senior Director, Clinical Science will coordinate with the members of the clinical operations team and be responsible for liaising with clinical investigators, clinical site staff, and outside vendors.

Key Responsibilities and Duties

Study Design and Protocol Development:

Involved in designing and developing clinical trial protocols, ensuring they are scientifically sound and adhere to regulatory guidelines. 

Data Analysis and Interpretation:

Analyze clinical trial data, interpret results, and draw meaningful conclusions to support decision-making regarding drug development and regulatory submissions. Support publication of data (abstracts, posters, etc.).

Safety Monitoring:

Manage sites to ensure that all safety decisions are made according to the study protocol in conjunction with the Medical Monitor / Study Physician and Pharmacovigilance.

Regulatory Compliance:

Ensure compliance with regulatory requirements (e.g., GCP, ICH), maintain and file accurate documentation. 

Communication and Collaboration:

Collaborate cross-functional with colleagues and contractors involved in the clinical development process, including clinical operations, drug safety, data management, and regulatory affairs, to ensure successful study execution. 

Report Writing:

Contribute to the preparation of clinical study reports (CSRs) and other regulatory documents. 

Stakeholder Management:

Participate in clinical Site-Initiation-Visits (SIVs), investigator meetings, and meetings with clinical Key-Opinion-Leaders (KOLs)/Clinical Advisors. 

Qualifications and Skills

• The candidate should hold a bachelor’s degree in life sciences or health-related field with an advanced degree such as a Masters, PharmD, or PhD in biological / pharmaceutical science preferred.
• Professional experience in the field of Clinical Science including oncology.
• Proficient knowledge and skills are required for the following critical activities:
• Program specific data review, trend identification, data interpretation, and presentation
• Medical writing including knowledge of terminology
• Knowledge of relevant regulatory guidelines including GCP and ICH
• Analysis of clinical information succinctly and efficiently with strong written communication – especially as it relates to developing clinical protocols or the assessment of the quality of data
• Interpersonal and decision-making skills with demonstration of innovation, drive, energy and enthusiasm to deliver key objectives on time.
• Keen proactive problem solving abilities.
• Communication, presentation, analytic and strategic capabilities and the ability to effectively collaborate with Cartography  colleagues, investigators, clinical staff, and medical experts.
• Willingness to travel in US occasionally (1-2 days/month)