Associate Director, Clinical Research Science

Associate Director, Clinical Research Science

The Clinical Development Group collaborates closely and maintains excellent working relationships with various internal groups, including but not limited to: Clinical Operations, Biometrics, Data Management, Pharmacovigilance & Drug Safety, Translational Medicine, Preclinical Science, Regulatory Affairs, and Medical Affairs. Clinical programs are developed in conjunction with input from external subject matter experts and consultants and are executed through partnerships with clinical research organizations.

Clinical Development is composed of a "hands-on" group of dedicated professionals. Team members work flexibly and collaboratively together in a matrix environment, with a high degree of personal accountability for the success of novel and aggressive clinical programs and timelines.

Responsibilities:

The CRS contributes to five key areas:

Ensures Quality Medical Science

• Leadership position in developing clinical study protocols, heath authority documents and other study related documents

• Ensures the study team, CRO and clinical trial sites understand and comply with the study protocol

• Serves as the Clinical Scientist on the study team and supports the Medical Monitor in leading review and interpretation of clinical data

• Ensures CRF design supports data collection in alignment with the protocol in collaboration with Data Management

• Collaborates cross-functionally as well as with the CRO to monitor clinical data to ensure quality, completeness, and integrity of trial conduct and patient safety via review of protocol deviations

Contributes to the Clinical/Program Strategy

• Contributes to clinical development plans

• Conducts literature searches for new indications for a given molecule including treatment, epidemiology etc.

Supports Regulatory Affairs

• Provides scientific and clinical rationale to health authority communications

• Supports clinical positions in regulatory interactions

Contributes to Scientific Communication

• Contributes to scientific publications including posters, abstracts, and manuscripts

Serves as Internal Clinical Development Expert

• Develops content and presents at Investigator Meetings and provides protocol or other study-related training to CRAs as well as research staff at trial clinical sites

• Communicates and/or collaborates with external experts such as Data Monitoring Committee Members, Trial Steering Committee, Principal Investigators, Key Opinion Leaders, Cooperative Groups, etc.

• Works cross-functionally with other internal groups (eg, Clinical Operations, Biometrics, Data Management, Pharmacovigilance & Drug Safety, Translational Medicine, Preclinical Science, Regulatory Affairs, Medical Affairs, Business Development, and New Product Planning)

Basic Qualifications:

• An advanced degree (Ph.D. or Pharm.D.) in a related field

• A background in life sciences

• 4+ years of experience working in the pharmaceutical industry

• Clinical study design, data collection, analysis, and data interpretation skills

• Experience working in oncology and or immuno-oncology

• Experience interacting with clinical investigators and medical experts

• Excellent verbal, written, and interpersonal communication skills (fluency in English is required)

• Domestic travel (approximately <10%) is expected

Preferred Qualifications:

• Direct involvement with human intervention research

• Track record of publications with human experimental research

• Experience with ICH, GCP and relevant regulatory requirements

Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Mural Oncology also complies with all work authorization and