Senior Clinical Scientist

7 days ago

Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Job Description

Deciphera Pharmaceuticals is a biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to improve the lives of people with cancer. We leverage our proprietary switch-control kinase inhibitor platform and expertise in kinase biology to develop a diverse portfolio of medicines.

We are seeking an experienced Associate Director, Clinical Research Scientist to join our team. The successful candidate will collaborate with a multidisciplinary, matrix work group to ensure that clinical and scientific issues are properly addressed in the development and execution of individual clinical studies and overall development plans.

Key Responsibilities:

  • Work closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to gather scientific and medical knowledge necessary to support clinical development plans and study designs and protocols.
  • Assist Medical Directors in creating proposed concept sheets for clinical studies and may write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts.
  • Drive the clinical contribution to annual updates of Investigator Brochures (IBs) liaising with Toxicology, Pharmacology, Safety, Regulatory, and Medical & Communication Experts.
  • Drive and integrate clinical contributions to answering regulatory queries and other submissions related to studies.
  • Monitor real-time study data to ensure the integrity of the study and the study data and interact with investigators and internal and external experts to resolve any study issues as they arise.
  • Be involved in high-level data cleaning activities requiring clinical judgment.
  • Be involved in analysis of complex data for regulatory submissions, publications, and design of studies and programs.
  • Act as a clinical/scientific expert on the products and studies in the therapy area.
  • Attend scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators and advisors.
  • Work with investigative sites to answer protocol-related questions, resolve study conduct and design issues.
  • May present data, protocol designs, and other information at advisory boards, investigator meetings, site initiations, and other internal and external settings.

Qualifications:

  • Advanced degree in Life Sciences (or BS plus equivalent experience); Pharm D, or BSN, or other equivalent clinical qualifications.
  • At least 5 years' experience in product and clinical development in a biotech or pharmaceutical company.
  • Understanding of GCP, ICH, and regional/local regulations.
  • Experience in both early and late-phase development.
  • Medical knowledge and experience in clinical development/operations (Oncology preferred).
  • Experience reviewing clinical data outputs.
  • Ability to perform literature searches and to utilize library services.
  • Ability to conduct basic data analyses using Excel and other tools.
  • Basic understanding of biostatistics to allow effective interaction with biostatistics experts.
  • May require approximately 15-30% travel.

Preferred Qualifications:

  • Teaching capability.
  • Excellent communication skills, both verbal and in writing.
  • Strong presentation skills.
  • Team player.
  • Ability to proactively predict issues and solve problems.
  • Ability to drive decision-making within a multidisciplinary, multi-regional matrix team.
  • Diplomacy and positive influencing abilities.
  • Experience building data presentation plans.

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