The Chief Operating Officer will be a strategic partner to the Chief Executive Officer and Board of Directors and will help provide the vision, leadership, strategy and general management skills to continue to successfully build a premier global Biotechnology Company.
The Chief Operating Officer will be a strategic, dynamic, highly collaborative, and successful senior executive who brings significant global commercial leadership experience in both development programs and marketed products. S/he will be responsible for building, leading and coordinating global operational and commercial activities for the company’s product portfolio. This person will be a business partner to the Chief Executive Officer and to other members of the management team.
This position will directly manage all commercial and technical operations as well as the global operational and commercial strategy that will ensure that PDS Biotechnology’s products reach the patients who need them worldwide.
Specifically, the Chief Operating Officer will have full P&L accountability and be responsible for commercial operations, technical operations, manufacturing, and supply chain, patient advocacy, and legislative affairs. The Chief Operating Officer will fully understand the full range of the company’s products in development and the cost and benefits, while having a complete understanding of the evolving competitive, regulatory and reimbursement landscape. S/he will externally interface with the patients, providers, payers, health authorities and regulators, existing and new strategic partners and the public financial community. The Chief Operating Officer will play a critical role in ensuring commercial success, advancing the company’s portfolio and taking the company to its next stage of future growth, thereby benefiting both patients and shareholders.
Specific responsibilities include:
• Serve as a key member of the Executive Committee in shaping the company’s vision and future direction. Lead the operational activities in the company.
• Provide overall executive leadership in creating and executing proactive global business and commercial strategies for products in development and registration. Conceive of and execute strategic and creative methods for advancing business goals.
• Have full accountability for the technical operations and be responsible for the organization meeting corporate goals and objectives and keeping in compliance with applicable policies and regulations.
• Lead the Global Operations organization. Ensure effective leadership of the following functions:
o US Operations
o Manufacturing
o Global Supply Chain and Technical Operations
o Program Management
o Strategic Alliance
o Commercial Operations
• Display and practice a visible, open, entrepreneurial and motivated leadership style throughout the organization; communicate and ensure that all employees understand the vision, values, and processes required to lead the company through its next growth.
• Provide hands-on leadership while managing multiple projects. Define goals and drive innovation while ensuring the correct team, processes and scalable infrastructure are in place to support rapid operational and commercial growth.
• Proactively build relationships and trust with key internal and external stakeholders and decision makers, including on a global level. Interact with PDS Biotech’s Board of Directors as it pertains to the role’s area of responsibilities.
• Serve as one of the spokespersons for the company; represent the company in its relationships with suppliers, major customers and partners, the business and financial communities, and the public to promote a positive image in the industry and to promote business growth and success.
• Directly contribute to successful corporate development activities in support of corporate development and strategy.
• Remain on the forefront of commercial requirements, the relevant options, products and the competitive, regulatory and reimbursement landscape including detailed competitive intelligence.
• Develop and ensure implementation of plans, budgets, and policies and procedures.
• Ensure and maintain safety and regulatory compliance in all company technical and commercial operations activities.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
This is a critical role for the company and one through which the successful candidate will be a major contributor in shaping the future growth and success of the company.
The successful candidate will be an accomplished strategic operating executive such as a successful Chief Executive Officer, Chief Operating Officer or Head of a Global Business Unit from the pharmaceutical, biotechnology or life science industry with an outstanding record of accomplishment building, managing, and leading global organization in specialty biopharmaceutical products.
The Chief Operating Officer will inspire confidence in the Board, senior management, investors and the biopharmaceutical community. This individual must possess proven operating experience, including demonstrated success in maintaining and growing significant global R&D and commercial business.
A passion for addressing patients’ requirements and a solid understanding of the industry’s complex regulatory, R&D, manufacturing, supply chain and commercial requirements with an absolute commitment to competing on the highest ethical level are essential.
More specifically, it is anticipated that the ideal candidate will possess:
• Strong general management, business and team building skills with over fifteen (15) years of public biopharmaceutical senior management experience and, ideally, P&L responsibility. An entrepreneurial and strategic builder rather than a “steady state” manager.
• Strong global leadership qualities including a track record of achievement as an executive level commercially minded business leader with more than ten (10) years of U.S.-based experience within an operating commercial business with complexity and scale. Additional, successful international leadership experience in global and/or ex-U.S. senior management roles is preferred. Experience in leading an organization through rapid growth and ability to manage the implementation of operating systems, processes and procedures while maintaining an entrepreneurial culture.
• Demonstrated success in building, developing and motivating teams and effectively growing an organization. Sophisticated, strategic, and proven commercial and operational experience with strong facility in devising complex commercial business plans and successfully commercializing products. A strong understanding of the dynamics of product development and patient requirements, the key financial drivers for market access requirements and the complexities of international commercialization.
• Demonstrated success with identifying strategic growth opportunities and driving an organization to capture value, including experience in business development and transactions. Experience in integrating new products, teams and businesses coming from licensing and mergers and acquisitions.
• Demonstrated track record of successfully leading suppliers, partnerships, co-promotions with the ability to effectively collaborate and negotiate with partners.
• Strong ability and personal style to inspire confidence and work successfully with varied audiences including the Board of Directors, current and potential industry partners, the management team, research and development, manufacturing, regulators, medical/ marketing cross functional teams and the public financial community.
• Ability to create a culture of performance and accountability in an organization. Translating over-arching goals into specific objectives and holding people accountable for results. Ability to stay focused on the most important metrics that drive the business.
• Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for commercial, research and development, manufacturing, regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends. Ability to engage regulators on new approaches and implement new strategies for product regulatory filings.
• Ability to build and maintain key external relationships across key stakeholders. Ability to present effectively to groups and manage through others to ensure adherence to the highest quality standards, with the ability to collaborate and drive for results.
• Strong understanding of the drug development process.
 
• Stature, experience, credibility, strong relationship-management and interpersonal skills to quickly gain confidence both with internal and external stakeholders. An individual who can influence strategic direction of complex global commercial issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with patients, physicians, providers, payers, regulators scientists, peers and managers.
• An individual who demonstrates humility, good judgment and strong analytical skills and adjusts quickly to changes.
• Excellent organizational and management skills and ability to think strategically.
• Outstanding presentation, written and oral communication skills required. A clear communicator who can influence effectively both internally and externally.
• A person of the highest integrity.
EDUCATION
Bachelor’s degree (BS/BA) is required; MBA and/or MD, PhD strongly preferred