Clinical Development Medical Director, Breast Oncology

Job Summary

This position is for a Clinical Development Medical Director within the prifetrastat program. This individual contributor will be responsible for supporting clinical trial(s) and lead sub teams in clinical development. The successful candidate should ideally have prior experience in clinical trials supporting development programs health authority interactions and demonstrated leadership capabilities to ensure that the clinical development program meets scientific ethical and regulatory standards.

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 4yearsofexperiencein 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

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.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel to scientific conferences / meetings several times per year as needed

Relocation support may be available

Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.

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