Associate Director Clinical Sciences - Remote Position

Puma Biotechnology, Inc.; Los Angeles (CA); Remote; USD 180,000 - 215,000; Full time

Job summary

Puma Biotechnology, Inc. is seeking an Associate Director of Clinical Sciences for a remote position. The role involves leading clinical projects, supervising Clinical Scientists, and ensuring quality in clinical deliverables. Candidates should have an advanced clinical degree and significant experience in clinical development, particularly in oncology.

Qualifications

• At least 5 years of clinical development experience in pharma or biotech.
• Knowledge of international regulations (ICH, FDA, EMA).
• Excellent oral, written, and presentation skills.

Responsibilities

• Advising on clinical development strategy.
• Reviewing and presenting clinical and non-clinical data.
• Managing assigned clinical development projects.

Skills

Clinical development plans

Data review and interpretation

Communication skills

Regulatory document development

Education

Advanced Clinical/Science Degree (e.g., PharmD, PhD, MSN)

Job description

Associate Director Clinical Sciences - Remote Position

Join to apply for the Associate Director Clinical Sciences - Remote Position role at Puma Biotechnology, Inc.

This role involves acting as a fully independent Clinical Science lead responsible for one or multiple drug projects, interacting with clinical development teams, regulatory authorities, and key opinion leaders. The position includes supervising other Clinical Scientists and ensuring the quality of all Clinical Science input and deliverables.

Responsibilities

• Advising on clinical development strategy
• Reviewing and presenting clinical and non-clinical data
• Writing and reviewing Clinical Study Reports and regulatory submission modules
• Representing projects at scientific and regulatory meetings
• Leading interactions with investigators and cooperative groups
• Managing assigned clinical development projects

Skills & Abilities

• Developing clinical development plans, protocols, and study management
• Data review and interpretation
• Experience in clinical studies development, especially in oncology
• Strong written and verbal communication skills for diverse audiences
• Regulatory document development and input

Qualifications

• Advanced Clinical/Science Degree (e.g., PharmD, PhD, MSN)
• At least 5 years of clinical development experience in pharma or biotech
• Knowledge of international regulations (ICH, FDA, EMA)

Additional Requirements

• Excellent oral, written, and presentation skills
• Experience communicating with senior management and external scientific communities

Management

• Up to 2 direct reports, including administrative staff

Compensation Range

$180,000 - $215,000 annually, with potential for higher based on experience and skills

Physical Demands & Travel

Primarily office work with extended computer use, occasional walking, standing, and travel (up to 10%, including international)

Puma Biotechnology Inc. is an equal opportunity employer, committed to diversity and inclusion.