Director, Clinical Science Lead

Bayer•Cambridge, MA

16h•$169,700 - $254,500•Onsite

About The Position

As a Clinical Science Lead, you will be a key figure in leading the clinical science perspective within global oncology development programs. You will create significant impact by safeguarding the quality and integrity of oncology studies and related medical data, optimizing decision-making, and enhancing drug development within a trial's framework. Assigned to highly complex and strategic priority clinical studies, you will provide scientific leadership to develop innovative protocol and study designs, ensuring a scientifically sound end-to-end study strategy.

Requirements

Advanced degree in health/life science-related field
Outstanding drug development expertise
Ability to acquire knowledge of different diseases and therapeutic areas
Relevant global health authority interactions and current knowledge of regulatory review and responses
In-depth knowledge of GCP/ICH, FDA, EMA, and other relevant guidelines and regulations
Adapts quickly to and promotes change and fosters innovation, sets the right priorities, seizes strategic opportunities, and adheres to high standards
High energy with focus and vision; self-motivated with a high sense of ownership, urgency, proactive and solution-oriented, flexible entrepreneurial and open-minded approach to new and creative ideas
Focuses on outcomes – independently defines and proactively delivers on highest and aspirational pipeline, team, talent and organizational impact outcomes
Acts, learns fast and evolves: works in 90-days cycles, applies learnings very fast and continually develops
Co-creates for customers: remains close to the customer - envisions, proactively conceptualizes and co-creates solutions for their needs.

Nice To Haves

Advanced degree in health/life science-related field with a minimum of 4 years of industry experience in a pharmaceutical/biotech business
Oncology experience.

Responsibilities

Act as the scientific leader and primary clinical-science representative for the global program(s) assigned
Perform scientific oversight of oncology clinical trials and ensure scientific integrity of the study from concept to final report. In this role, you will participate in the development of the Clinical Development Strategy and Plan and provide expertise to various deliverables necessary for effective and efficient execution for the program
Plan and execute all matters related to data-driven decision making, focusing on patient centricity, urgency and speed ensuring a sound data-driven strategy. As such, the CSL is responsible for all clinical science related aspects and supports/partners with the Integrated Product Med Lead and other clinical trial scientists on overall study planning, preparation, management, evaluation, and documentation
Promotes a creative and innovation-friendly collaboration between clinicians and scientists to evolve Early Clinical Development Oncology’s unique value contribution and the development of a robust pipeline and thereby drives the development of a productive and fulfilled workforce by embracing a culture of creativity and innovation, while ensuring that capabilities are available and actively evolving
Takes ownership for the entire Early Clinical Development Oncology team, fosters a culture of ownership in support of the strategy and in line with the Bayer’s values. Empowers others and drives peer accountability across portfolio deliverables and beyond
Can lead and drive ECDO-initiated (cross-)functional strategic initiatives in support of the overall ECDO, RED-ONC, Oncology and/or Bayer strategy
Independently leads self-empowered matrix teams in-line with Bayer’s VACC leadership standards by enabling, empowering, and supporting colleagues in a high-performance environment under a culture of psychological safety. He/She takes accountability for the respective team outcomes.