SVP Clinical Development

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

The Senior Vice President, Clinical Development will be instrumental in directing the clinical development program of the company’s drug candidates across multiple indications. As such, this individual must be capable of not only contributing to the selection of oncology indications to pursue, but also helping to determine the overall development strategy for the company.

The Senior Vice President, Clinical Development will be responsible for the Clinical Development organization, including the translational, clinical sciences, program management organizations, external medical directors, and possibly biometrics. The physician-scientist will define and implement a system for peer scientific review of standards of care, new study concepts, and final clinical protocols; furthermore, they will provide clinical-technical input into regulatory submissions and align with development and commercialization objectives. The SVP will be responsible for the creation, integration and execution of clinical development plans.

This individual must have strong communication skills to help articulate this strategy to colleagues, Board members, investors and external partners. The individual must have presence, credibility and a style that bodes well for success in such relationships.

Major Duties/Responsibilities

Specific duties and responsibilities of the Senior Vice President, Development will include:

• Managing, building, and leading clinical development teams to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH, and other global regulatory requirements

• Playing a key role in defining “go/no-go” decision points, timelines and resources in alignment with the research and development goals and objectives of the collective as well as individual indications

• Playing a critical role in defining and executing clinical development strategy in the context of financial and market environments, clearly articulating and developing opportunities and threats, and evaluating options and plans against anticipated commercial and scientific trends

• Managing and maintaining strong, effective relationships with key external stakeholders and partners (i.e. KOLs and investigators, global vendors, consultants, patient advocacy groups, and other external clinical trial participants) to ensure that the primary goals of the clinical development programs are met

• Leading medical monitoring activities including acting as primary point of contact for day-to-day medical guidance for clinical trial staff at study sites, as well as for regulatory, safety and clinical operations and other functions requiring clinical input

• Providing clinical and medical guidance while working closely on joint projects with the medical affairs team to include IST studies, Scientific Congress/Conference strategy and planning, Advisory Boards, development of educational goals for medical education, publications, Field Force training, review of medical information standard response letters, health economics analyses, and marketing/policy related projects

• Leading in the strategic clinical development plans and execute on same, including, for example managing or assisting with:

  • Scientific literature review and summarization

  • Protocol development

  • Regulatory briefing document preparation and review

  • Investigator meeting preparation and presentations

  • Clinical study report input

  • Assistance with writing and preparation of abstracts, presentations, and manuscripts

• Working with the team to identify and evaluate scientific, business licensing, partnership, alliance and outsourcing opportunities

• Working with key scientific and business executives in preparing presentations to the Board of Directors and Advisory Committees

• Effectively communicating clinical information to both technical and non-technical audiences to enable them to create a compelling case for the company’s efforts with potential customers and the investment community

Skills & Abilities

• Must have a solid understanding of oncology and/or hematology drug development and life-cycle management

• Full working knowledge of Good Clinical Practice guidelines. Demonstrated familiarity with PhRMA (the Pharmaceutical Research and Manufactures of America) code of conduct and with regulatory guidelines as they pertain to Phase IV activities

• Experience in planning and execution of clinical trials and investigator sponsored trials

• Ability to understand, interpret and explain scientific research and publications, presentations, and dissemination of clinical research data

• Experience supervising technical and managerial staff over a wide range of accountabilities in development

• Experience as a member of a senior management team responsible for achieving corporate goals

• Excellent oral and written communication skills and interpersonal skills

• Strong leadership, team building, negotiation, and ability to execute

• Ability to manage multiple projects in a fast-paced environment

• Ability to cultivate and maintain relationships throughout the organization and with thought leaders around the world and to establish trust through the consistent demonstration of scientific expertise

• Willingness to travel within the US and internationally as required

Education & Professional Experience

Education

• Advanced Life Science Degree (MD, MD/PhD, DO or equivalent) strongly preferred

• Extensive clinical development experience in lieu of educational experience listed above may be considered

• Board Certification in oncology preferred

Experience

• 5-10 years related international clinical development experience with a mix of corporate and academic experience required

• Experience in Oncology is strongly preferred

• Experience in Breast Cancer and/or Small Cell Lung Cancer preferred

Work Environment

Puma functions as a remote working environment, with an office in the Westwood area of Los Angeles available for use as needed. While working remotely, we maintain a professional, virtual environment. This role routinely uses standard office equipment such as computers, phones, and other technology supporting remote working.

Physical Demands

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 role are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Employees must have the ability to remain seated for long periods of time while working on computer or referring to documents, and must have manual dexterity to operate a computer keyboard and standard office equipment.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are typically Monday through Friday, 8:30 AM to 5 PM. However, this position regularly requires more extended work hours, and the ability to be flexible regarding work hours depending on the needs of the business.

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.

Compensation Range

The salary range for this role is $410,000 - $440,000 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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