Senior Director/Vice President, Clinical Development

OPPORTUNITYMammoth Biosciences is hiring a Senior Director/Vice President, Clinical Development who will be responsible for leading clinical development strategy for programs across our portfolio. Reporting to the SVP, Translational Sciences, the Sr. Director/VP will be an important leader within the Development organization as we drive towards clinical Proof of Concept (POC) with MB-111 and simultaneously begin the work of longer range integrated and clinical development plans.
The Sr. Director/VP role will include both entrepreneurial leadership elements (leading clinical strategy and driving clinical programs initially) as well as partnering with other Development Leaders to build the capabilities, team, operating system & culture within the broader Development organization as Mammoth grows into a clinical stage platform biotech company.

KEY RESPONSIBILITIES

• Clinical Development Strategy & Leadership
• Lead the strategy and own the medical responsibility for the clinical development of MB-111 and other pipeline programs, including accountability for the overall clinical development plans, innovative clinical studies and protocols, and timely execution and medical monitoring in close collaboration with relevant internal and external partners, Clinical Research Organizations (CROs) and regulatory agencies
• Lead Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables
• Drive innovation in design of clinical development plans and study protocols within the disease area, accessing world-class expertise through external and internal collaboration 
• Support early-stage programs in the therapeutic area by bringing in disease insights and clinical research expertise
• Successful execution of clinical development plans, study protocols,
• Ownership of Investigator Brochures, Clinical Study Reports, posting on Clintrials.gov, regulatory documents such as pre-IND and IND submissions
• responses pertaining to clinical development, and other program documents 
• Ensure high quality and timely interpretation of clinical data, including through meeting abstracts, posters, presentations, and publications for internal management review and external scientific/clinical meetings
• Provide Medical Governance with specific accountability for managing and mentoring clinical staff in the disease area line and ensure proper training and compliance with internal and external policies, guidance, laws and codes. Ensure clinical trials adhere to cGCP and compliance with FDA, EMA and other relevant national regulatory agency requirements
• Develop risk-based safety monitoring of clinical trials and implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues


• Enterprise Leadership
• Serve as a role model for leaders across the organization in their quality of structured thinking, problem definition/solving, the ability to understand and integrate diverse perspectives to issues, navigate conflict
• Have a broad perspective on organizational issues fostered by seeking out and building an understanding of other leaders and team members 
• Develops & coaches’ top talent to accelerate individual and team performance across the enterprise 


• Inform business strategy, proposes new directions for the business linked to the evolving competitive landscape, marketplace & customer insights 
• Challenges assumptions and conventional wisdom with specific, supported,reasoned proposals
• Thinks 2-3 years ahead into next business cycle
• Acts to surpass goals, seizing opportunities to push the envelope, leveraging internal & external stakeholders & innovative business strategies
• Sets continually higher goals that are ambitious but realistic for self and team, geared to organizational objectives
• Negotiates with a genuine give-and-take approach & uses multiple influence strategies to create win-win scenarios wherever possible
• Spends time identifying all stakeholders necessary, brings a mindset of curiosity to understand different perspectives, & builds effective relationships across the organization

REQUIRED QUALIFICATIONS

• MD or MD/PhD with demonstrated track record building and leading high-impact clinical development teams across different stages of the product life cycle (pre-IND thru BLA to commercialization) and a minimum of 8 years experience leading clinical and medical operations for Sr. Director level; minimum of 10 years experience for VP level
• Experienced in leading complex business initiatives and dynamic teams in a matrixed environment, in reporting levels both horizontally and vertically
• Data-driven with a high affinity for science and wi