Posted on 25th June 2020
Clinical Trial Director
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Summary of Position
As the Clinical Trial Director, you will be responsible for managing Clinical Research Organization’s (CRO), managing the clinical team, managing budgets and directing activities related to supporting clinical trial design and assuring clinical trials are efficiently and effectively executed against project timelines. This will include facilitating external medical experts as the clinical development program of new products is defined. In addition, the position will define operating procedures bridging sponsor requirements to the CRO ensuring requirements are followed for respective responsibilities. The position will evaluate clinical product development against target product and medical plan and adjust clinical strategy to meet changing market and competitive conditions. This position requires strategic thinking, interaction with KOL’s, FDA regulatory experience and the ability to work cross functionally to formulate and implement action plans to meet the vision, goals and timelines of the company.
- Plan, develop, organize, implement, direct, and evaluate Curium’s clinical product development activities.
- Develop and execute strategic clinical product trial development programs, both short and long range, to support financial and business development objectives of the organization.
- Enhance and/or develop, implement and enforce policies and procedures of the organization by way of systems that will improve the overall operation and effectiveness of the organization.
- Provide strategic input to the Senior Director of New Product Development and other functional heads regarding business opportunities, market and customer expansion and overall commercial direction of the company.
- Direct implementation and execution of clinical product trial development policies and practices.
- Partner with members of the management team to ensure communications are coordinated, support corporate objectives and meet organizational expenditure requirements.
- Determine suppliers of record and negotiate contract terms and conditions for major services.
- Serve as liaison with outside agencies regarding clinical trials.
- Ensure effective control of clinical product development activities and take corrective action to guarantee that achievement of objectives fall within designated budgets.
- Monitor competitive products and product development activities.
- Establish and maintain relationships with industry influencers and key community and strategic partners.
- Resolve conflicts and facilitate change to ensure objective fulfillment and swift response to problems and opportunities.
- Coordinate and assist in the ongoing training and development of clinical development team members.
- Provide direction to product development teams by establishing clear goals and objectives for performance.
- When requested by leadership, help represent the organization at scientific meetings.
- Recommend, approve, analyze and control expenditures to conform to budgetary requirements.
- Prepare periodic product trial development activity reports.
- Maintain compliance with applicable federal, state and corporate regulations.
- Manage recruitment of personnel.
- Present progress reports and strategies to management.
- Advanced technical degree in a science related field.
- Ten to fifteen years of broad clinical product development experience in the pharmaceutical, biotech industries or working directly for a CRO.
- Five years of supervisory experience of direct reports required.
- Matrix management experience required of external conducting concurrent projects.
- Experience in the review and selection of CRO’s.
- FDA regulatory experience is required as is interaction with key opinion leaders (KOL’s).
- Budgetary management experience required.
- Proven analytical and strategic thinking skills, planning and implementation experience, track record of successful negotiations.
- Excellent written and verbal communication and presentation skills.
- Team player with high integrity and an open, interactive style with strong interpersonal skills.
- Assertive, confident, decisive and results-oriented.
- Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Ability to conduct personal and area radiation surveys, control radioactive contamination through good laboratory practices and effectively decontaminate radioactive work areas.
- Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation.
- Must possess good hand-eye coordination.
- This position will require overnight travel.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Posted on 18th June 2020