The Clinical Development leader will report to the Executive Vice President, Chief Strategy Officer and be responsible for overseeing drug candidate programs for Qualigen Therapeutic’s oncology pipeline programs. The VP Clinical Development will define strategy and drive implementation of drug development and scientific communications. In addition, the VP, Clinical Development, Oncology will lead clinical science aspects of design, execution, interpretation and reporting of clinical trials in collaboration with CROs. Manuscript writing and submission, and presentation of data (to KOLs, shareholders, investors, analysts, potential partners) will also be an important component of the incumbent’s responsibilities. This clinical role serves as the company’s medical expert to develop and execute medical/scientific strategy, including scientific evidence generation and scientific information exchange with key stakeholders. The Vice President Clinical Development will exemplify collaboration in a progressive culture that puts patients first while delivering shareholder value.

The position will encompass responsibility for both internal and external stakeholders.
Internal stakeholders include the CEO, Chief Strategy Officer, Project Management Team, Leadership Team, Board of Directors, while external commitments include those to CROs, Consultants, Analysts and Investors, potential and existing Partners, and Thought Leaders.

Key Tasks & Responsibilities

• Design, plan and execution of clinical trials, and running programs focused on oncology viral disease programs in accordance with regulatory and quality standards, and company timelines and budgets.
• Ensure that all clinical activities related to clinical trials are managed effectively in support of regulatory submissions and subsequent approval.
• Develop and deliver presentations of clinical strategy and results internally as well as externally to KOLs, investors, analysts, potential partners.
• Possess clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions.
• Collaborate with CROs, academic scientists, clinical experts, and study investigators.
• Clinical leadership for business development and partnership activities.
• Demonstrate clinical leadership for investor relations activities.
• Develop and deliver presentations at clinical advisory boards and medical/scientific meetings.
• Develop and maintain relationships and serve as the main medical liaison with KOLs.

Additional Key Tasks and Responsibilities

• Display robust understanding of Phase I-III drug development with track record of planning clinical trials, delivering high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, review medical monitoring / safety assessment / pharmacovigilance and generate clinical/scientific documents.
• Champion high standards of compliance, ethics and safety, and putting patients first.
• Provide strategic leadership and design input for Oncology clinical programs.
• Write and review medical aspects of clinical and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions.
• Develop and communicate clinical study design and results messaging.
• Oversee safety for clinical studies.
• Contribute to the development and review of scientific publications.

Education

• MD in Oncology and US medical license required.
• Ph.D. preferred.

Professional Skills & Experience

• 8-10 years+ in clinical development in the pharmaceutical industry
• Prior experience working in both big pharma and small/emerging company is strongly preferred.
• Results-proven clinical program leadership and achievement of deliverables, effective collaboration
• Results-oriented with proven record of getting things done.
• Strong project management skills, leadership credibility and influencing skills.
• Clear and transparent communicator who is articulate and confident.
• Decisive leader who influences and engages others in the accomplishment of shared goals.
• Ability to work independently and thrive in a fast-paced environment.
• Attention to detail, demand for high-quality work, and urgency to achieve goals and improve the lives of patients.
• Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.
• Strong business acumen, including working knowledge of changing U.S. payer and provider landscape.
• Demonstrated ability to establish relationships with internal colleagues and external collaborators (e.g., investigators, KOL’s/CROs) and represent the company in external events/meetings.
• Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.
• Excellent knowledge of relevant FDA regulations and guidelines for conducting clinical trials.
• Science-and data-driven
• Results-oriented work ethic and a positive, can-do attitude
• Hands on and track record of delving into details

Personal Skills & Competencies

• Leadership by example — hands-on clinical programs, projects, communication and leadership to help create and stick company’s culture.
• Ethics — treats people with respect, inspires the trust of others, demonstrates integrity.
• Authentic leadership — leading with authority, empathy and influence.
• Communication— listens and gets clarification, responds well to questions, speaks clearly and persuasively in positive and challenging situations.
• Teamwork— balances team and individual responsibilities, gives and welcomes feedback, contributes to building positive team spirit, puts success of team above own interests, supports everyone’s efforts to succeed.
• Project Management— Executes and communicates changes and progress, completes projects on time and within budget.
• Analytical, pragmatic approach to problem solving.

Please forward CV, resume, and correspondence to careers@qualigeninc.com