Clinical Development Director – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in Clinical Development for Prostate cancer

• Aid in the formulation, implementation, and dissemination of the global scientific/medical evidence strategy

• Facilitate cross-functional and global collaborations to incorporate extensive medical, scientific, and commercial insights into the development program

• Foster the establishment of essential scientific external relationships with opinion leaders

• Engage and provide clinical insights during safety and regulatory discussions

• Deliver clinical/scientific input throughout the planning and execution of clinical trials

• Analyze clinical trial data

• Contribute to safety evaluations

• Engage in interactions with regulatory authorities

• Draft Clinical Study Reports (CSRs), publications, and regulatory submissions

• Develop relationships with key opinion leaders and deliver scientific presentations at advisory boards, key scientific meetings, and external committee meetings as assigned by the Global Development Leader

• Identify novel clinical research opportunities

• Assist in in-licensing and out-licensing efforts and partner relations

• Support product lifecycle management for new indications as directed by the Global Development Leader

• Provide clinical content input for: Regulatory interactions and documents, Safety interactions and documents, Materials for Scientific Affairs, Materials for the Commercial Organization

⛳️ Requirements

• MD or DO degree from an accredited medical institution AND 2 years of clinical research experience and/or basic science research

• 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care roles, particularly in GU Oncology (prostate cancer)

• Clinical research experience within the biopharmaceutical sector (biotech, pharmaceutical, or CRO company)

• Comprehensive understanding of the scientific method and clinical applications grounded in medical, scientific, and practical reasoning

• Familiarity with clinical research concepts and clinical trial design, including biostatistics

• Strong scientific and clinical judgment

• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and relevant international regulatory standards

• Capability to effectively communicate complex medical/clinical concepts in both written and verbal formats

• Proven track record as a medical expert in a complex matrix environment

• History of resolving issues while demonstrating exceptional judgment and a balanced, realistic perspective on challenges

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions

• Group medical, dental, and vision insurance

• Life and disability coverage

• Flexible spending accounts

• A discretionary annual bonus program, or, for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off policies

• Flexible work models where feasible