Our client is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies.
Their portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs.
We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies.
Position Overview
We are seeking a highly experienced Director / Associate Director, Clinical Scientist to join their team. The Director / Associate Director, Clinical Scientist will play a critical role in the design, execution, and interpretation of multiple clinical trials for our oncology drug candidates.
This individual will work closely with cross-functional teams, including clinical operations, regulatory affairs, and research and development, to ensure the successful progression of multiple clinical programs.
Responsibilities
- Design and develop multiple clinical trial protocols, informed consent forms, and other study-related documents.
- Collaborate with principal investigators, key opinion leaders, and clinical trial sites to ensure robust study design and execution.
Serve as Lead Clinical Scientist for multiple trials.
- Conduct activities related to data generation and validation, including CRF design and clinical data review / query resolution
- Ensure clinical trial data integrity and adherence to regulatory requirements.
- Contribute to the preparation of clinical study reports, regulatory submissions, and publications.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Perform site-facing activities such as training and responding to clinical questions.
- Participate in the development of clinical development plans and timelines.
- Present clinical trial data and findings to internal and external stakeholders, including scientific advisory boards and regulatory agencies.
- May provide mentorship to other team members.
- Travel may be required
Qualifications
- PhD, MD, PharmD, MS, or equivalent degree in life sciences
- Minimum of 5 years of experience in clinical science, clinical research, or equivalent; preferably in oncology.
Knowledge and Skills
- Extensive experience in drug development process, study design, clinical operations
- Extensive experience in clinical trial data analysis software and tools.
- Strong knowledge and skills to support program specific data review, trend identification, and data interpretation
- Strong understanding of regulatory requirements and guidelines for clinical trials (e.g., GCP, ICH, FDA).
- Excellent analytical, organizational, and communication skills.
- Ability to work effectively in a fast-paced, collaborative environment.
- Strong problem-solving skills and attention to detail.
Director of Clinical Program Management
A company is looking for a Director, Operational Design - Clinical Program Management. ...
Service Area Director Clinical Education RN
The SEWA Service Area Director of Education and Practice is a professional Registered Nurse who assumes primary responsibility for directing and coordinating clinical educational and practice related activities for the Service Area and for supervising assigned caregivers at all ministries. The Direc...
Clinical Director
We have a new assignment for a Clinical Director position in Tukwila, WA and are interviewing ASAP. ...
Clinical Lab Director
Clinical Laboratory Director Opportunity. Their cutting-edge facility offers comprehensive testing solutions, and we are looking for a dynamic Clinical Lab Director to lead their exceptional team. The Clinical Lab Director will oversee all laboratory operations, ensuring adherence to regulatory stan...
Service Area Director Clinical Education RN
The SEWA Service Area Director of Education and Practice is a professional Registered Nurse who assumes primary responsibility for directing and coordinating clinical educational and practice related activities for the Service Area and for supervising assigned caregivers at all ministries. The Direc...
Clinical Scientist, Director, Primary and Specialty Care
The Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiological study execution ensuring consistency of approach, conduct, result reporting and oversight of core team activities within one or more specialty or primary asset programs. Represents Clinical Affairs line in pro...
Sr Director, Clinical Development LIVER (MD)
You may act as a Clinical Development Lead and Physician Responsible on clinical trial programs in the Inflammation and Fibrosis therapeutic area. Clinical development activities include molecules / products targeting primary biliary cholangitis (PBC), other cholangiopathies, and metabolic dysfuncti...
RN, Hospice Director of Clinical Services
Clinical Manager, Director of Clinical, Director of Nursing, Patient Care Managers, etc. RN, Hospice Director of Clinical Services (DCS). Director of Clinical Services (DCS). REQUIRED: Hospice & hospice clinical operations management experience required. ...
Director Of Clinical Operations-surgical Services
DIRECTOR OF CLINICAL OPERATIONS-SURGICAL SERVICES. Surgical Services has a leadership opportunity for a Director of Surgical Services Clinical Operations. The Director of Surgical Services Clinical Operations. Directing, Managing, and Coordinating all clinical and operational aspects of Harborview’s...
Sr Director, Clinical Development LIVER (MD)
You may act as a Clinical Development Lead and Physician Responsible on clinical trial programs in the Inflammation and Fibrosis therapeutic area. Clinical development activities include molecules / products targeting primary biliary cholangitis (PBC), other cholangiopathies, and metabolic dysfuncti...