Associate Director, Clinical Research
Location: Waltham, MA
Palleon Pharmaceuticals is seeking a driven and experienced Associate Director, Clinical Research to work closely with the Chief Medical Officer. The Clinical Research Scientist (CRS) will provide support to one or more clinical project teams at Palleon Pharmaceuticals. The CRS will have an opportunity to make an impact through strategic and scientific input, as well as scientific support of clinical programs. S/he will ensure the successful design and implementation of science-driven clinical development plans which will bring novel therapies to patients. In collaboration with the Chief Medical Officer, Clinical Operations and Program Management teams, the CRS will provide effective scientific oversight of studies, perform clinical data review and analysis of study results, and prepare clinical trial results for regulatory submissions. Major areas of responsibility include contributing to clinical trial design and execution of company-sponsored clinical trials at all phases of development, clinical trial data analysis, internal and external communication of project plans and progress, safety monitoring and mitigation. The CRS will make key contributions to regulatory submissions, publications, and clinical data communications.
- Contribute to the design and development of the Clinical Strategy while working in close collaboration with and following the guidance of the Chief Medical Officer and entire Clinical Development Team.
- Contribute to the design of clinical trials and the writing/review of protocol concepts, full study protocols, and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.).
- Organize expert panels and advisory board meetings to provide input into the clinical plan, study design and data findings.
- Anticipate risks and manage/mitigate them along with the Chief Medical Officer, Program Manager, and other team members, as appropriate.
- Collaborate with patient advocacy groups, external investigators, and other stakeholders.
- Oversee the conduct of clinical trials, making sure all clinical activities are carried out under GCP compliance.
- Select appropriate CRO partners for various aspects of study execution.
- Assist with managing other vendor activities including laboratory, histology, and imaging.
- Deliver high level presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff.
- Provide guidance and/or training to internal/external personnel/parties involved in clinical studies.
- Review clinical study and scientific data and perform analyses to enhance the understanding of clinical programs.
- Monitor analyses of emerging safety/tolerability findings.
- Work collaboratively with the translational medicine group on the identification, selection, and validation of biomarkers to support the clinical development plans.
- Facilitate, assist and/or participate in the preparation of clinical study manuscripts with investigators, internal personnel, and medical writers.
- Maintain expertise in the relevant therapeutic area; review scientific journals, attend key scientific and technical meetings, and partner with company medical, research, and translational teams.
- PhD, PharmD, or MD highly desired.
- Minimum of 7 years of clinical development experience in the biotechnology/pharmaceutical industry.
- Experience in Oncology a plus.
- Exemplary critical thinking, problem solving and decision-making skills.
- Strong scientific knowledge of the drug development process.
- Proficient knowledge of GCP/ICH, study design, statistics, and clinical operations.
- Excellent verbal and written communication skills and interpersonal skills. Ability to effectively communicate and collaborate across job functions and levels.
- Proven scientific writing skills, including ability to evaluate, interpret, and present complex data.
- Creativity and/or ability to put innovative approaches into practice in clinical development.
- Strong sense of teamwork, ability to influence others and build collaborative relationships.
- Resilient and tenacious with willingness to challenge ideas and assumptions.
- Flexibility and willingness to adapt to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
- Willingness to travel (up to 20%)
Who We Are:
Palleon Pharmaceuticals is the leading biotechnology company developing drugs that target glycan-mediated immune regulation to treat cancer and inflammatory diseases. The company’s proprietary platforms integrate technologies and insights from global scientific leaders in the glyco-immunology field to overcome historical scientific hurdles and create novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, an enzymatic sialoglycan degrader for T cell exhaustion in cancer, is expected to enter clinical testing in 2021. The company has several other drug discovery programs underway in disease areas where glycan-mediated immune regulation plays a role, including inflammatory diseases such as autoimmunity and fibrosis. Palleon was launched in 2015. The company recently raised a $100 million Series B financing from leading investors Matrix Capital Management, Surveyor Capital (a Citadel company), SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures and AbbVie Ventures. Learn more at www.palleonpharma.com.