Title: Program Team Lead (Director/Sr. Director)

ABOUT THE COMPANY

At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.

SUMMARY OF POSITION

Program Team Lead (PTL) is tasked with steering our therapeutic programs from their inception to their successful launch in the marketplace. This leadership role involves managing the product lifecycle of a drug candidate, ensuring each aligns with QurAlis’ commitment to delivering innovative healthcare solutions. The PTL will navigate the complexities of drug development with meticulous attention to detail, adhering strictly to QurAlis’ mission and to the multifaceted paths of regulatory compliance and market entry strategies. As an integral driver of our strategic objectives, the PTL will be central to instilling hope and providing advanced treatments to patients across the globe. 

Primary Job Responsibilities:

• Drive strategic planning and execution of program deliverables
• Lead and synchronize a cross-functional team, including R&D, regulatory affairs, CMC, commercial, and finance to align with program objectives. 
• Develop and manage complex project plans that include precise timelines, budget allocations, resource distribution, and comprehensive risk mitigation strategies. 
• Maintain a clear channel of communication with senior management and stakeholders regarding program progress, risks, challenges and opportunities. 
• Utilize data-driven insights to navigate the program outcomes, making pivotal decisions to overcome obstacles and capitalize on opportunities. 
• Develop a cohesive and high-performing program team, fostering innovation, accountability, and professional growth. 
• Assure compliance with all regulatory guidelines and adherence to QurAlis’ standards throughout the program lifecycle. 
• Maintain a comprehensive understanding of all external vendors and collaborators essential to the success of the program. 

Primary Job Requirements:   

• Multiple years’ experience in program leadership within the biotechnology or pharmaceutical industry.
• Comprehensive understanding of the entire drug development process, including in-depth knowledge of regulatory environments, clinical development, Chemistry, Manufacturing, and Controls (CMC), and strategic approaches to commercialization. 
• Outstanding leadership skills, demonstrated by the ability to mentor and unify team members towards a common goal. Possesses the ability to effectively present and advocate for the program's direction to the QurAlis management board, ensuring alignment with strategic objectives. 
• Strong communication, negotiation, and interpersonal skills, with a proficiency in conflict resolution. 
• Strategic thinking and problem-solving abilities, adept at managing complex projects under pressure.