Vice President, Translation Sciences
About the role
Provide broad scientific input to activities directed toward clinical programs. Translational Science 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. This leader must have a vision of excellence in translational research and be able to conceptualize it across oncology, metabolic disease, neurology, cardiology, hematology and other medical disease opportunities as Sana expands its pipeline. A strong foundation in immunology is desired. This Head will interface with Research teams and contribute to the strategic planning and execution of clinical research protocols and development plans, provide scientific support of regulatory submissions, contribute and provide scientific input to publication planning, commercial initiatives and eventually medical affairs. This position is expected to hire and manage a world-class translational science group of PhDs, MD/PhDs and other scientists in the Translational Sciences function.
What you’ll do
- Scientific oversight for biomarker, clinical pharmacology, imaging and safety related assays in planned and future clinical trials throughout conduct and support of all medical and scientific aspects of clinical trial (s) and program level activities as assigned, including interpretation of results, clinical study reports and graphical displays
- Manage an expanding group of translational scientists that will be interfacing with Research and Development groups as new therapies are advanced
- Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trials to support regulatory applications or future business/marketing objectives
- 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 clinical operations on the implementation and execution of translational aspects of 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 KOL advocacy development
- 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
- Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
- General familiarity with biostatistics; 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
- Working safely in person on a predictable and regular in-person 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, including receipt of a vaccine booster shot if recommended by the CDC
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, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.
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, 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.