Senior Manager, Clinical Science - Remote Position

The Senior Manager, Clinical Science serves as the Clinical Science lead for one or more clinical development programs, providing scientific leadership throughout the lifecycle of assigned studies. This position is responsible for driving high-quality clinical science strategy and execution by partnering with cross-functional teams, investigators, key opinion leaders, and regulatory authorities to support the design, conduct, analysis, and reporting of clinical trials.

The Senior Manager, Clinical Science ensures scientific integrity across Clinical Science deliverables, contributes to regulatory submissions and interactions, and provides expert clinical input to support development milestones and strategic decision-making.

Responsibilities may include some or all of the following:

Major Duties / Responsibilities

• Facilitate and execute the creation, update, and/or review of key clinical and regulatory documents, including, but not limited to:

  • Protocol concepts, synopses, protocols, and amendments

  • Informed consent documents

  • Investigator Brochures

  • Clinical study reports

  • Abstracts, posters, and manuscripts

  • Clinical sections of INDs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports

  • Clinical study supporting documentation and processes, e.g.: charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc.

• Supports all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical studies.

• Partner with relevant functional areas for the successful implementation and execution of clinical studies.

• Specific tasks will include but are not limited to the following:

  • Provide clinical and scientific expertise for selection of investigator and vendors

  • Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol

  • Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs

  • Review, query, and analyze clinical trial data

  • Partner with Medical Director on medical monitoring, patient eligibility and study treatment related questions

• Present clinical trial data, both internally and externally

  • Create clinical study or program-related slide decks for internal and external use

• Represent a clinical study or development program on one or more teams or cross functional sub teams

• In collaboration with the Medical Director/Medical Monitor, build and maintain KOL/investigator networks; organize and present at KOL advisory boards and investigator meetings

• Contribute to or perform therapeutic area/indication research and competitor analysis

• Build strong relationships with internal experts.

• Develop, track, execute and report on goals and objectives.

• Be accountable for compliant business practices

• Additional responsibilities as required

Required Education and Professional Experience

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

• Minimum of 3 years of clinical development experience in the pharmaceutical or biotechnology industry

• Must have experience in the development of Phase 2 to Phase 3 clinical studies (preferably in the oncology area)

Other Requirements

• High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills

• Ability to work independently and build working relations throughout the organization and with business partners to achieve business goals

• Experience with the development and support of clinical development SOPs and policies is a plus

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

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 (local time), 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 as needed (up to 15% expected, including international travel).

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 $145,000 – $175,000 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.

Originally posted on Himalayas