Senior Director, Clinical Biomarkers-Oncology

About the role  

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  As the Senior Director, Clinical Biomarkers- Oncology, you will report to the Executive Director of Clinical Sciences to provide broad scientific input to activities directed toward clinical programs. The Clinical Biomarker Group at Sana spans research from in vivo to in-human studies and assesses key aspects of response/non-response, clinical pharmacology, biomarkers, imaging, clinically relevant histology, and other research that explains how our therapies are safe and effective. Cool stuff.

What you’ll do  

• Scientific oversight and accountability for biomarker and safety related assays in ongoing and planned clinical trials. Support of all medical and scientific aspects of clinical trial (s) and program level activities as assigned, including clinical pharmacology, imaging, interpretation of results, clinical study reports and graphical displays
• Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trials to support regulatory applications or future business/marketing objectives
• Lead cross-functional teams, including CRO partners, focused on development and implementation of clinical biomarker assays
• Perform integrated data analysis in close collaboration with colleagues in Data Management, and comprehensible presentation of clinical biomarker data to teams with diverse scientific backgrounds and experience
• Identify and evaluate emerging novel scientific platforms for biomarker discovery and development
• Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents
• Identify significant issues and risks that may impact overall project plans and initiate contingency plans as appropriate
• Maintain close collaboration and cooperation with colleagues in Clinical Operations and Quality Assurance on the implementation and execution of ongoing and planned clinical studies
• Contribute and be responsible to the development planning, authoring and review of manuscripts and other scientific data disclosures
• Contribute to departmental resource planning, budgeting and timeline setting to meet company needs
• Serve as a scientific interface to key opinion leaders (KOL), facilitating collaborative scientific opportunities with clinical investigators
• May provide oversight and coaching to more junior clinical research staff

What we’re looking for

• PhD or MD/PhD degree with a minimum of 10 years of combined academic and biotechnology or pharmaceutical industry experience in Clinical Research
• Prior experience in translational research with a significant publication track record supporting this experience
• Deep understanding of and direct clinical experience in more than 1 disease area
• Broad and deep understanding of approved and investigational therapies for these disease areas
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Prior industry experience contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements
• Demonstrated ability as a scientific and or medical expert in a complex matrix environment
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment

What will separate you from the crowd   

• Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
• General familiarity with biostatistics, flow cytometry, multiplex IHC/IF, proteomic and transcriptomic data generation and analysis; expert in navigating scientific literature, interpretation of data, display of data
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures

What you should know  

• Occasional nights, weekend and holiday work could be required during periods of time to meet deadlines
• Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19
• The base pay range for this position at commencement of employment is expected to be between $240,000 and $290,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together

• Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution 

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.  For more details on our benefits, visit Sana’s Benefits Portal.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.