The EVP & CMO is the chief architect of the clinical development and product registration road maps, bridging basic science with clinical science, setting the development and regulatory strategy. The CMO will lead, manage, and direct the Company’s discovery and clinical development programs, medical science, and regulatory affairs registration pathways. The CMO provides leadership, strategic insight, and operational expertise for the Company’s research, development, medical and regulatory affairs functions.
- Leadership and management of the full life cycle of discovery and clinical development including but not limited to Chemistry, Translation & Structural Biology, Clinical Operations, Medical Affairs, Biostatistics and Pharmacovigilance, in addition to Regulatory Affairs & Quality.
- Steward early discovery, translation medicine and early development strategies to identify and advance new drug targets and bridge preclinical and early clinical phases to elevate probability of success and the speed in which portfolio assets are advanced to late stage phases.
- Leadership on clinical content and development strategy on regulatory submissions and interactions.
- Leadership of all Regulatory Affairs related activities supporting submissions and CMC and other regulated activities.
- Recruit and develop talent to build highly capable Discovery, CMC, Development, Quality, Pharmacovigilance and Regulatory Affairs organizations.
- Serve as the clinical spokesperson interfacing with external stakeholders including KOLs, regulatory authorities, advisory board members, clinical research investigators and collaborators.
- Plan and manage overall budgets.
- Participate on global discovery, medical and clinical, and product registration committees as appropriate.
- Promote and integrate industry best practices that fit well with the Company’s operating culture.
- Promote a highly interconnected discovery and clinical research operating culture.
- Establish and oversee compliance to local/global SOPs and work practices governing all phases of the discovery and clinical research process.
- Ensure that discovery and clinical research pathways are developed to support registration roadmap with full understanding of the risks and opportunities.
- Promote a high performance –results oriented collaborative and nimble work culture.
- Support Business Development and New Product Planning and assessment activities specifically related to clinical programs analysis and due diligence.
- Participate in meetings and committees of Sumitomo Dainippon Pharma Group as requested by the CEO.
- Establish collaborative and productive relationships with parent company and relevant affiliates.
- Perform other duties as requested by the CEO.
- MD or MD/PhD board certified oncologist.
- Minimum of 15 years drug development leadership track record in oncology; focus on GI tumors a plus.
- Track record of advancing PoC through Ph. II/III stage therapeutic candidates through the clinic to regulatory submission and approvals on a global scale, ideally with a demonstrated track record of successful interactions with US and global regulatory agencies.
- Track record of strong leadership across the spectrum of clinical and medical activities.
- Established reputation as a respected clinical research scientist and/or a practitioner, along with well-developed relationships and network amongst thought leaders in oncology.
- Possess business knowledge, interest and sensibility, with a demonstrated ability to positively influence clinical and commercial development of biopharmaceutical products.
- Ability to see ahead clearly and anticipate future consequences and trends accurately.
Executing for Results
- Possess a strong track record of setting and achieving compelling objectives and goals with drug development programs. Strong experience translating the vision/mission of the organization into actionable, quantitative plans. Demonstrated track record of leading by example and leading others in problem solving and finding creative solutions based on sound judgment.
- Demonstrated ability to manage teams across the clinical and medical functions. Strong track record of attracting and developing top technical and scientific talent, and be a visible and engaging leader.
Building Relationships and Using Influence
- Well- developed ability to build and sustain excellent relationships with stakeholders such as the Board of Directors, parent company executives and clinical development teams, key opinion leaders, investigators, regulators, shareholders, and vendors.
- Keen ability to serve a credible ambassador both internally and externally and convey confidence and a sense of optimism about development plans and paths forward.
Job Location: Cambridge, MA
Equal Opportunity Employer
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