Theorem Clinical Research (formerly known as Omnicare) is one of the industry’s leading full-service, global CROs, providing core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics and a strong presence in Asia (particularly China)
Theorem Clinical Research have the capability to manage even the most complex project – from study design to product launch and beyond.
Theorem Clinical Research are “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization.
Theorem’s comprehensive clinical service offering includes the following:
• Project Management
• Clinical Monitoring*
• Clinical Data Management*
• Regulatory Affairs*
• Clinical Quality Assurance
• Safety Surveillance/Pharmacovigilance*
• Clinical Writing
• Investigator Agreements
• Medical Affairs
• Patient Recruitment
To improve patient lives through rapid acceleration of breakthrough disease management projects.
To manage our clients’ clinical trial projects faster and more effectively than our competition through:
• Dedicated business units led by a team of operational experts and executive oversight
• Global, specialized and experienced project teams comprised of well-trained clinical experts
• Delivery of personalized and high quality customer service
• Execution of localized site and patient recruitment strategies
• Leveraging of our innovative processes and eClinical technologies
Theorem Clinical Research – History
Theorem Clinical Research may be new, but it is built on a long history of delivering exceptional services and support.
Prior to their launch in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company.
Theorem has grown into a global organization with 1,000+ employees in global office locations throughout 32 countries with a commitment to their clients and their success.
2011: Omnicare Clinical Research is acquired by Nautic Partners, LLC, a strategic growth private equity firm. As part of the move, Omnicare Clinical Research became Theorem Clinical Research.
2010: Integrated operations with sister CRO Clinimetrics Research Associates, another wholly owned subsidiary of Omnicare, Inc. This integrative approach has led to an increased therapeutic reach, exchange of expertise and expanded global resources, coupled with specialization into focused business units designed to meet the specific needs of clients.
2009: Launch of Cardiovascular, Oncology and Vaccines Therapeutic Advisory Teams to provide projects with additional support from a medical, operational, regulatory and cost-effective perspective.
2008: Client Placement Service, bringing Omnicare Clinical Research clinical professionals on-site to client locations for extended assignments, formalized under the OmniTEAM® —Tactical Expertise And More—brand name.
2007: Launch of OmnieView University, our state-of-the-art eLearning Management System that provides targeted, on-line training to internal and external project members.
2006: Launch of empowered brand positioning and new tagline: People Who Really Care. In a Company Where it Really Matters(tm).
2005: Celebration of Omnicare Clinical Research 20th Anniversary
2004: Omnicare, Inc. acquires sister company Clinimetrics and strengthens medical device trial capabilities.
2003: Omnicare Clinical Research’s PAGeR Business Unit is established to provide dedicated resources for conducting peri-approval (Phase IIIB and IV) trials and clinical research projects in seniors.
2002: Opened offices in Bangalore, India and Tokyo, Japan to further penetrate Asia Pacific Region.
2000: Omnicare Clinical Research established.
Theorem Clinical Research are structured into six distinct business units in order to optimize client satisfaction:
• Early Phase
• Phase II/III
• Late Phase
• Medical Device
• Technical Services
Theorem Clinical Research’s Early Phase Business Unit (Phase I/IIa) has a dedicated, streamlined approach that helps ensure they complete your study on schedule and on budget. Their goal is to exceed client expectations, each and every time.
Early Phase Study Type Expertise:
• Single Ascending Dose (SAD)
• Experimental Medicine
• Drug-Drug Interaction
• Pharmacokinetics (PK)
• Dosing Finding/Ranging
• Food Effect
• Thorough QT Studies (TQTS)
• Multiple Ascending Dose (MAD)
• Proof of Concept
• Bioavailability/Bioequivalence (BA/BE)
• Pharmcodynamics (PD)
• Bridging Studies
• First in Man (FIM)
Early Phase Therapeutic Expertise:
Phase II/III Clinical Trials
As a mid-sized CRO, Theorem Clinical Research are the “right size” outsourcing partner. Small enough to provide clients with a personal touch and ability to maintain their focus on their clients, with a global reach across 32 countries, in all the key drug development markets, big enough to conduct large and complex global trials.
Theorem Clinical Research are able to assist their clients taking advantage of:
• Strong Therapeutic Experience History
• Global/Program Efficiencies
• Project Acceleration
• Site Management And Patient RecruitmenT (SMART) Team
• Proven Governance Model
• Highly Qualified and Experienced PDs
• Global FootprintLate Phase
Late Phase (Phase IIIb/IV) trials are more important than ever. Whether it’s a proactive investigation into health outcomes, a safety surveillance study, Risk Evaluation and Mitigation Strategies (REMS), or leveraging a competitive advantage with a label extension, Late Phase research is a valuable commercial investment. Theorem’s team of experts help to create a customized Late Phase study designed to achieve your particular goals and objectives.
Health Outcomes Peri-Approval Trials
Pharmacoeconomics Patient/disease registries
Patient reported outcomes Investigator-initiated trials
Quality of life assessments Expanded access programs
Cost utility Treatment INDs
Epidemiological trials Observational studies
Time in motion measurements Longitudinal investigations
Phase IV trials
Whether you’re investigating an apparatus, instrument, machine or other type of device, Theorem’s Medical Device Business Unit appreciates success hinges upon highly specialized regulatory, reimbursement programs, safety and marketing support. Operating on high-quality systems, Theorem can prepare those key documents that will ultimately clear your product for marketplace entry.
Even after your commercial launch, Theorem will help propel your device to that next level, from developing a reimbursement strategy to meeting post-marketing surveillance requirements.
Theorem Clinical Services have a complete suite of Superior Solutions, Clinical Data Management, Biometrics and Medical Writing—all Wrapped with eTechnologies.
Clinical Supplies Packaging, Labelling, Storage and Distribution Services to Streamline Your Clinical Trial.
For nearly two decades, Theorem have been designing and implementing packaging to simplify even the most complicated dosage regimens. Their global presence provides cost-effective, timely delivery of any study medications and medical devices anywhere around the globe.
Clinical supplies packaging
Clinical supplies labelling
Clinical supplies storage
Clinical supplies distribution
For further information, please see: http://www.theoremclinical.com/
Primary Purpose of the Job
Reporting the VP Business Development, International you will be responsible for the identification, negotiation and securing of new client relationships within your region and portfolio of companies. You will also serve as overall Account relationship manager and strategic business partner for established account(s), in liaison with senior and operational Management.
You will be responsible for developing and expanding new business opportunities within allocated account(s) to include developing and overseeing the sales strategy for assigned clients, managing the sales process and coordinating with Project Management to ensure client satisfaction. The focus will be on a given territory but with the scope of work to incorporate other European markets and to work as a key member of the business development team.
Having recently evolved to become Theorem Clinical Research, the company is looking to develop a unified global business development structure and approach. Theorem Clinical Research are looking to further enhance the calibre of the business development team through the hire of experienced, focused and exceptional Senior Account Directors and Account Directors who will lead, manage, motivate and mentor BD teams.
We are seeking individuals with strong networks and expertise, coupled to an impressive track record of success within one or more of the following areas:
• Blue chip pharmaceutical clients
• Emerging and developing medium and small pharmaceutical clients
• Biotechnology clients
• Geographical expertise within the UK / Benelux / Scandinavia regions
• Geographical expertise within the German / Swiss / Southern Europe regions
Reporting to the Vice President Business Development, International, the Senior Account Director will be responsible for the identification, procurement and client management for allocated business in Europe. As well as being responsible for nurturing relationships with and securing business from allocated customer accounts, you will proactively identify and qualify new potential clients, develop relationships with decision makers and stakeholders and obtain business from them. This will involve:
• Managing the complete sales cycle from cold calling to negotiating and closing the sale
• Acting as point of contact to the client
• Responding to client requests
• Assisting in the preparation and review of proposal (including FTE and financial estimates)
• Negotiating budgets, contracts, and assisting in the negotiation of ‘out of scopes’ as appropriate.
You will be expected to develop a comprehensive understanding of Theorem Clinical Research’s full portfolio of products and services arming you with the means to cross-sell and react appropriately to client needs.
Additional to this you will play a key role in the management and development of a business development / account management team in your region(s) and disciplines. This will involve:
• Ownership and management of a team target.
• Responsibility for the training, development, mentorship and direction of the team.
• Line management for more junior team members.
• Assigning clients and accounts as appropriate.
• Input into the European / Global BD approach and strategy.
• Ability to drive sales, profitability and at all times maintain and develop the Theorem Clinical Research brand and culture.
• Actively prospect and leverage potential new business opportunities within specified clients.
• Cultivate strong, long-term relationships with key decision-makers within accounts and develops deep knowledge of the account organisations.
• Identify and analyse potential opportunities and develop detailed business plans and sales strategies for each customer in liaison with CRU Management. Monitor actions and results against plans.
• Identify and respond to client needs in order to define potential Theorem Clinical Research opportunities. Ensure appropriate strategy and solution is proposed to the client.
• Work with Project Directors and Function Managers to identify most appropriate sales team and prepare presentation. Educate team participants in client culture, operational needs, methods and sales techniques required to close the sale.
• Lead the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation.
• Coordinate with the Proposal Development Group (PDG) to develop proposal and CRU Management to finalise strategy and pricing.
• Handle any follow-ups related to the sales and facilitates completion of contractual documents.
• Ensure appropriate hand-off to project team by transferring knowledge regarding client needs and expectations.
• Share account strategies and sales plans with Project Directors and Project Managers.
• Coordinate with Project Managers, Project Directors and CRU Management to escalate and quickly address client issues and concerns.
• Seek input from Project Managers and Project Directors as required to proactively address Changes In Scope (CIS), new opportunities or customer dissatisfaction.
• Work with Project Managers, Project Directors and CRU Management to ensure CIS’s are appropriately negotiated with the client.
• Maintain high visibility within client organisations.
• Monitor client satisfaction through regular formal and informal surveys.
• Coordinate with Project Managers and Project Directors to ensure the needs of the client are being met and address any concerns and issues in a timely manner.
• Advanced degree in business or scientific discipline is preferred but not mandatory.
• Relevant scientific / medical / commercial qualifications.
• Former experience in life sciences: Pharma, biotech, device, or consulting. Clinical Research experience is critical, ideally from an operational and business development perspective.
• Demonstrable competency in sales or business development preferably for a Contract Research Organisation or company providing Phase II/III services to the healthcare industry.
• An established network within the “region” pharmaceutical and biotechnology marketplace would be desirable.
• Fluent written and spoken English and local market language skills.
• A solid understanding of the clinical process (Phase II – III) coupled with a desire to develop existing knowledge.
• Proven track record of successful business development and strong negotiation skills required.
• Broad commercial experience and exposure to developing and closing significant deals and major accounts.
• Solid understanding of the CRO sector and drug development.
• Desire to build a career in sales and sales management.
• Relish the challenge of identifying and building new relationships, internally and externally.
• Credibility in both a Clinical and Commercial environment.
• Strategic business awareness and results orientation.
• A record of demonstrable personal achievement.
• Team player with outstanding inter-personal skills, negotiation skills and organisational skills.
• Ability to work closely both with commercial and operational teams to ensure increased revenue, profitability and quality of deliverables to clients.
• Knowledge of FDA regulated drug development process helpful.
• High-level skills in Microsoft PowerPoint.
• Self-motivated with a desire for success.
• “Hands on” and “can do attitude”.
• Outstanding interpersonal skills, personal selling skills and ability to “think on your feet”.
• Excellent stakeholder/relationship management. Comfortable with internal and external client relationships.
• Comfortable with managing and being managed against financial targets.
• Clear ability to lead, manage, mentor and motivate others.
• Highly credible in both a Clinical and Commercial environment.
• Experience of working within dynamic and growing environments.
• The ability to think both analytically and creatively and to use your initiative.
• Desire and ability to build and sell the business.
• Open and transparent working style.
• Excellent prioritisation and organisation skills.
• Highly results focused.
• International and cultural awareness.
• Consultative and flexible approach.
• Approachable, personable and supportive of others.
• Team player capable of working independently and with others.
• Ability to juggle a complex and heavy workload and prioritise as appropriate.
• Strong decision making ability with the “courage of your convictions”.
• Thrives under pressure while maintaining a high level of personal and professional integrity.
• Clear desire and ambition for success, comfortable making decisions and prepared to make the personal commitment to ensure success.
• Strong detail orientation and an ability to work creatively in a fast-paced environment.
• Excellent planning/organisational skills and ability to prioritise and multitask.
• Results orientated.
• Ensure written communications are accurate and consistent. Consistently follows up on issues in a timely manner.
• Listen carefully and ask questions when necessary to ensure understanding.
• Conveys information in a clear, concise, and accurate manner.
• Display an open and flexible attitude, with a desire to support others and genuinely operate within a team structure and a team player.
• Seek input from others when faced with a difficult situation. Make sound decisions within the scope of responsibility. Focus on resolving problems.
• Demonstrate leadership skills. Maintain positive relationships with clients and colleagues.
• Demonstrate honesty and integrity in dealing with others. Works effectively with different types of people.
• Portrays sound knowledge of clinical research and clinical development processes.
• Demonstrates professionalism and presents a positive image of Theorem Clinical Research. Listens to and then demonstrates an understanding the customer’s needs before presenting a solution.
• Ability to effectively handle difficult and complex customer situations. Maintains a high energy level when interacting with customers to find a creative solution.
• Willingness to learn and build upon your existing knowledge of drug development.
• Clear and presentable understanding of the long terms needs within clinical research as well as the customers’ immediate and short term resource requirements.
• Maintains positive relationships with clients and colleagues. Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts and applies constructive feedback.
• Seeks input from others when appropriate. Makes sound decisions within the scope of responsibility. Focuses on resolving problems.
• Demonstrates commitment, dedication, cooperation, positive behaviour, adaptability and flexibility with changes in responsibilities and duties.
• Base salary commensurate with experience
• Life Assurance of 4 x base salary
• Long Term Disability Insurance – up to 2 years of salary
• Private Medical insurance for employee and family, company funded
• Membership of Group Personal Pension Scheme – Company contribution to match employee contribution at 2.5% or 5% contribution
• Car Allowance £510.00 per month
• Company funded fuel for business and private mileage within the UK• Holiday 25 days per annum
• Hours 9.00 to 5.30 i.e. 7.5 hours per day 37.5 hour week
• Additional flexible benefits