Executive Director, Clinical Development
Location: Waltham, MA
Palleon Pharmaceuticals is seeking a highly motivated and experienced Executive Director, Clinical Development (EDCD) to work closely with the Chief Medical Officer to advance Palleon’s pipeline of novel therapeutic candidates. Together with the senior leadership team, s/he will play a major role in implementing Palleon’s strategy to bring innovative medicines to patients who suffer from serious diseases. The EDCD will ensure the successful design and implementation of science-driven clinical development protocols. In collaboration with the Chief Medical Officer, Clinical Operations and Program Management teams, s/he 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 EDCD will make key contributions to regulatory submissions, publications, and clinical data communications.
- Develop early clinical development strategies while working in close collaboration with and following the guidance of the Chief Medical Officer and entire Clinical Development Team.
- Collaborate with Palleon senior leadership to design, prepare and initiate protocol concepts, full study protocols, and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.).
- Coordinate with Palleon’s Discovery Team to assure smooth transitioning of development candidates/programs from research to development.
- Work collaboratively with the Translational Team to identify, select and validate biomarkers to support the clinical development plans.
- Anticipate risks and manage/mitigate them along with the Chief Medical Officer, Head of Clinical Operations, Program Manager, and other team members, as appropriate.
- Organize expert panels and advisory board meetings to provide input into the clinical plan, study design and data findings.
- Collaborate with patient advocacy groups, external investigators, and other stakeholders.
- Collaborate with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; maintain the highest quality clinical programs, following GCP and ICH guidelines and the Company’s standard operating procedures.
- 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 parties who are 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.
- 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.
Qualifications and Skills:
- PhD, PharmD or MD desired.
- Minimum of 10 years of clinical development experience in the biotechnology/pharmaceutical industry.
- Experience in oncology required.
- Extensive experience with Pre-INDs, INDs, and EOP1/EOP2 meetings.
- Strong knowledge of FDA and ICH regulations.
- Exemplary critical thinking, problem solving and decision-making skills.
- Strong scientific knowledge of the drug development process.
- Experience developing biomarkers to support clinical assets.
- 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 the ability to evaluate, interpret and present complex data.
- Creativity and the ability to put innovative approaches into practice in clinical development.
- Strong sense of teamwork, ability to influence others and build collaborative relationships.
- Resilience and tenacity with willingness to challenge ideas and assumptions, and ability to solve complex and/or abstract problems.
- 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 harness glyco-immunology to treat cancer and inflammatory diseases. The company’s proprietary platforms integrate technologies and insights from global scientific leaders in the field to overcome historical scientific hurdles and create novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, E-602 (formerly called Sialidase-Fc), is an enzymatic sialoglycan degrader for T cell exhaustion in cancer which is expected to enter clinical testing in 2021. The company has several other drug discovery programs underway in disease areas where glyco-immunology 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.