Theragnostics is a small but growing UK headquartered clinical stage company developing a portfolio of innovative radiopharmaceutical products for both the management and treatment of cancer patients,. Theragnostics currently has distribution agreements with ROTOP Pharmaka GmbH and GE Healthcare for the distribution of products within the US. To support US distribution, FDA approval, and commercialization in the United States, Theragnostics, Ltd., established Theragnostics, Inc., a wholly-owned subsidiary company based in Braintree, Massachusetts.
The Sr. Director of US Operations is responsible for the management of all aspects of Theragnostics’ US-based commercial distribution and future manufacturing operations and general management of other US-based business operations in support of global business strategies.
Location: Braintree, MA
Reporting to: CEO/President
Essential Duties and Responsibilities
Additional duties may be assigned.
• Leadership and line management of all US employees, including but not limited to regulatory, quality, business development, project management and administrative functions.
• Provide appropriate oversight and guidance to the critical functions of the business with particular attention to product distribution, alliance management of US partners, quality and regulatory programs, and growth of the US product market.
• Maintain a comprehensive program of employee benefits suitable for attracting and sustaining highly motivated and talented individuals.
• US oversight of the planning, implementation, and tracking of the Company’s new drug application (“NDA”) to the FDA for the agency’s review and approval.
• Lead the effort to establish and maintain a third party manufacturing partner relationship in the US.
• Coordination and communication of US-based activities with the global CEO and COO.
• Act as the registered agent for the Company with the US FDA and individual states in which the company conducts business.
• Act as the legal representative and Power of Attorney for normal business transactions conducted out of the US office.
• Prepare and maintain the financial budget for the US office. Support good financial practices through established and/or new relationships with accounting and banking partners.
• Make decisions on issues that could delay project schedules or activities; provide input on budget requirements pertaining to Quality Assurance and Regulatory Affairs; monitor project performance against goals.
Lead and coach direct reports and other company staff in the company’s obligations and responsibilities for providing safe and effective drug products.
Certificates, Licenses and Registrations: None required
Education and/or Experience:
• Master’s degree in a science or other related discipline.
• At least 10 years of experience in the pharmaceutical industry with at least eight years of increasingly responsible experience in commercial manufacturing/distribution and/or Quality functions.
Abilities and skills Required:
• Strong leadership skills; self-starter, good listening skills
• Strong oral and written communication skills, and negotiation skills
• Ability to analyze multiple inputs and variables and make decisions.
• Willing to set and drive aggressive project timelines
• Capable of strategic thinking and proposing innovative solutions to quality problems
• Comfortable in a results-driven, highly accountable environment where you can make a clear impact
• A team player, who listens effectively and invites response and discussion
• Experience in reimbursement, sales and marketing and/or market access would be desirable
• Experience with MS Office Suite and other appropriate software programs essential to the operation of the business.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• This position requires minimal travel; average travel for this position is ≤25% with some variation based upon the demands of the business imperatives.