Senior Director Clinical Science - Remote Position

Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.

The Senior Director, Clinical Science (Non MD) is a senior clinical science leader responsible for shaping and driving clinical development strategy and providing scientific oversight across one or more programs.

This role partners closely with cross-functional development teams and interfaces externally with regulatory authorities, investigators, cooperative groups, and key opinion leaders (KOLs) to ensure high-quality clinical science input and deliverables across the product lifecycle.

The Senior Director provides functional leadership for Clinical Science, including mentoring and managing Clinical Scientists, and is accountable for the quality, timeliness, and scientific integrity of Clinical Science deliverables supporting assigned programs.

Major Duties / Responsibilities

Clinical & Development Strategy Leadership:

• Advise on and drive the development and execution of clinical development strategy across one or multiple projects/programs.

• Provide scientific leadership to program teams by reviewing, interpreting, and synthesizing clinical (and when applicable, preclinical) data and relevant literature to support development decisions.

• Oversee the clinical management and scientific support of all drug products/programs (or equivalent portfolio scope), balancing priorities and ensuring consistent scientific standards.

Data Review, Interpretation & Scientific Communication:

• Review, interpret, and present clinical and related scientific data at internal governance forums and in external settings, including regulatory meetings, congresses, and advisory committees.

• Communicate effectively with senior management and represent Clinical Science perspectives in leadership discussions.

Regulatory & Scientific Documentation:

• Lead authoring and/or critical review of key clinical documents (i.e. Clinical Study Reports, Clinical Study Protocols and clinical components of regulatory submissions (e.g., NDA/MAA and other submissions).

• Maintain expertise and executional capability for development and writing of key regulatory documents (e.g., IND, NDA/sNDA, Investigator's Brochure [IB]) and ensure scientific accuracy and completeness

External Scientific Leadership:

• Represent supported projects at scientific conferences and advisory committees, serving as a credible scientific spokesperson for assigned programs.

• Lead interactions with investigators and cooperative groups to support study execution, data interpretation, and scientific positioning.

Functional Leadership & People Management:

• Provide oversight of the Clinical Science team supporting assigned programs and/or broader Clinical Science function, ensuring quality and consistency of deliverables.

• Hire, develop, mentor, and performance-manage Clinical Science staff with appropriate technical and leadership capabilities.

• Act as lead contact / senior clinical science escalation point for assigned development project(s).

Additional Responsibilities:

• Perform other duties as assigned in support of Clinical R&D objectives.

Skills, Abilities & Competencies:

• Demonstrated ability to build relationships, create alignment, and lead high-performing teams in a collaborative manner to achieve program objectives.

• Strong understanding of product development, including preclinical and clinical development, trial execution, post-approval considerations, and regulatory expectations.

• Advanced capabilities in clinical development planning, protocol design/writing, study team leadership, data review/interpretation, and CSR delivery.

• Strong written, oral, and presentation skills with the ability to communicate internally with senior leadership and externally with congresses/advisory boards.

• Skilled in functional and cross-functional people and project management in matrix environments.

• Deep knowledge of international regulations pertinent to clinical development (e.g., ICH, FDA, EMA).

Supervisory Duties:

• This role will manage Clinical Science staff and is responsible for hiring and performance management of employees reporting into the function.

• Expected scope may range from 10 direct reports at program level to up to 15 direct reports with broader functional oversight, depending on organization size and portfolio needs.

• Required Education and Professional Experience

• Advanced Clinical/Science degree (e.g., PhD, PharmD, or equivalent) preferred.

• In lieu of an advanced degree, candidates may qualify with 15-20+ years of directly relevant clinical research/development experience in pharmaceutical or biotechnology settings, demonstrating progressive scope and leadership impact equivalent to advanced-degree training.

• Must demonstrate strong working knowledge of global regulatory requirements (ICH/FDA/EMA) and a sustained record of high-quality clinical science deliverables and leadership.

Baseline Experience Expectations

• Significant clinical development experience in pharma/biotech with accountability for clinical strategy, data interpretation, and regulatory documentation contributions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires working outside of these hours and may extend to evenings and weekends as business needs require.

Work Environment

This position operates in a professional, virtual environment, working from a remote location, usually the employee's home.

Travel

Travel may include local, out-of-area, overnight, and international travel as business needs dictate. Typical expectation may be up to 10% (including international travel), with variability by program stage and external engagement needs.

Physical Demands

This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds.

Compensation Range

The salary range for this role is $275,000 - $325,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.

At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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