Associate Director, Clinical Science — Trial Strategy & Data Review

Deciphera Pharmaceuticals, Inc.; Waltham (MA); Presencial; USD 171.000 - 236.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary and annual bonus

Comprehensive benefits package

Generous parental leave

Growth opportunities

Descripción de la vacante

Deciphera is seeking an Associate Director Clinical Scientist to drive execution of the clinical development plan, operationalize studies, monitor data in real time, and provide medical review and data interpretation for regulatory documents and publications.

The role requires interaction across clinical operations, data management, biostatistics, regulatory, medical affairs and translational medicine, with up to 20% travel and a focus on Hematology-Oncology or rare diseases.

Formación

• PhD or equivalent plus 5+ years of experience or bachelor/master’s degree plus 10+ years of experience post‑graduation that includes pharmaceutical industry experience in clinical drug/biologics development and the associated regulatory processes.
• Strong organizational skills to ensure that necessary data collection and documentation are accomplished for the required analysis and interpretation of clinical trial results.
• Ability to interact with internal team members and external partners effectively.
• Experience with clinical data analysis.
• Ability to influence decision‑making within a multidisciplinary team in areas of expertise.
• Excellent communication and presentation skills.
• Business Travel: up to 20% may be required.
• Experience across Phase I‑III drug development trials preferred, with focus on Hematology‑Oncology and/or rare disease.

Responsabilidades

• Monitoring of clinical data and ensuring patient safety; elevate issues to medical director as appropriate.
• Collaborate with data management, clinical operations, and medical monitors to ensure efficient data review.
• Communicate and elevate issues to investigators as appropriate.
• Work with cross‑functional team on EDC builds per protocol specifications.
• Authoring of clinical documents including concepts, study protocols, investigator brochures, and regulatory documents.
• Generate clinical outputs and interpretation for internal and external interactions; review outputs with Biostatistics and Pharmacovigilance.

Conocimientos

PhD or equivalent

Clinical data analysis

Regulatory processes

Cross‑functional collaboration

Communication skills

Travel readiness

Educación

PhD or equivalent

Bachelor/Master’s degree

Descripción del empleo

Deciphera is seeking an Associate Director Clinical Scientist to drive execution of the clinical development plan, operationalize studies, monitor data in real time, and provide medical review and data interpretation for regulatory documents and publications.

The role requires interaction across clinical operations, data management, biostatistics, regulatory, medical affairs and translational medicine, with up to 20% travel and a focus on Hematology-Oncology or rare diseases.