Clinical Development Medical Director, Breast Oncology
Job Summary
Job Responsibilities
Clinical Development Leadership on Study Teams and Development Subteams
- Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
- Lead peer-to-peer interactions with investigators
- Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
- Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.
- Provide clinical development leadership across several study teams.
- Serve as the Clinical Development representative on subteams including for Marketing Authorization Applications.
Strategic Guidance, Clinical Insights & Interpretation
- Collaborate with the Global Development Team to create and refine development strategies.
- Represent the company in external engagements or as committee member in joint collaborations.
- Collaborate with Clinical Scientists to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
- Maintain a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.
Basic Qualifications
- As medically qualified individual, the successful candidate must have the following qualifications:
- Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has 4+ years of experience in biopharmaceutical industry in clinical research and development.
- Been licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period.
Preferred Qualifications
- Board certified/eligible in oncology or equivalent preferred
- Breast Oncology experience (2+ years)
- Late phase clinical development experience preferred
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week
Sunshine Act
EEO & Employment Eligibility
Not included in the source posting: about the role, benefits.
Skills
Who can apply
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