• CEO
• Manager of Quality Assurance
• Program Director
• Director of Clinical Affairs
• Director New Product/Business Development & Commercialization
• Product Manager
• Manager of Specialty Pharmacy Contracting
• Director of Sales
• Marketing Director
• Director of Quality & Regulatory
• Product Marketing Manager
• Clinical Manager
• New Product Development Engineer

CEO

Our client, a well-known billion dollar Chicago based Venture Capital firm is seeking a CEO with Healthcare, Biotech or Pharmaceutical experience.  This person will add to their bench strength which will allow them to buy or build a company around the successful candidate.  The individual they are seeking has a proven pedigree, a track record of building successful companies, and growing profitability. 

This Venture Capital experience allows them to add value to their portfolio companies through strategy development, operational guidance, and sharing of best practices.  In addition they assist with financing, acquisition and other capital market transition to improve profitability and revenue.  They look to invest $20 million to $300 million equity in each opportunity.

The successful individual will have managed a company with $10 million - $100 million in revenue with EBITDA of $5 million - $25 million range.  They are looking to build relationships with executives who can be value-added partners.

Manager of Quality Assurance

A well known Chicago based manufacturer of Medical Devices is currently seeking a Manager of Quality Assurance.  This individual will be responsible for developing, maintaining and managing the Quality System for compliance with FDA, ISO, Canadian Medical Device and other International Ministry of Health requirements applied to currently approved products and products under development. 

Essential Duties and Responsibilities:

• Maintain and improve existing processes, and develop new quality system processes to ensure compliance with applicable guidelines for medical devices. 
• Participate in Continuous Improvement Initiative development and execution.
• Direct technicians engaged in inspections and testing activities at remote facility to ensure continuous control over materials, facilities, and product.  Formulates and monitors quality measurements and objectives.  Facilitate and oversee the daily operations of assigned Quality System process (e.g., Document Control, CAPA, Consumer Complaints, Repair Activities, and Audit program).

Education and/or Experience

• Degree and/or equivalent experience, with minimum 5 years experience in a health sciences, regulatory, clinical, QA, QC, or other related technical field in an FDA regulated industry. 
• Experience in interactions with FDA, other regulatory authorities, and/or ISO/CMDCAS notified bodies required. 
• Experience with Medical Devices or related products.
• This person could be a Quality Engineer or Supervisor who is ready to step to the next level. 

Compensation

• Excellent base, bonus and benefit program commensurate with experience and industry standards.

Program Director

Our client, a well known East Coast based manufacturer of Medical Devices seeks a Program Director to manage these programs from product design to commercial manufacture.

Essential Job Functions:

• Maintaining the program management systems to support the overall project, including implementation of project schedules for product design through commercial manufacture.
• Managing, processing and delivering the technical information required by the suppliers components. Developing productive working relationships with each supplier and their technical teams.
• Monitoring and updating the resource levels needed to meet project objectives and relaying this data to other functional managers, including workforce planning.
• Ensuring all project activities are in conformance with Company’s Quality Management System.
• Coordinating cross-functional project teams in their implementation of this program.
• Working with the Program Engineer to maintain project schedules for all phases and components of the program.
• Reacting to change productively and handling other tasks as assigned.  Working to improve all aspects of the project in support of business plans.  Support peers and immediate supervisor by anticipating problems, offering solutions and continuously improving the function of the Company.
• Providing long term vision of project schedule, identifying and mitigating potential risks.

Education/Experience Required:

Bachelor’s degree in a science or engineering field required; advanced degrees preferred.  Experience managing the development of new medical device products from design to manufacture is required.  Experience successfully operating in a highly interdependent team environment is required.  Advanced process, analysis and problem solving skills are required.  Advanced reporting, technical writing and computing skills are required.  Knowledge of FDA and ISO requirements for medical device design and manufacture and experience working within ISO quality systems is required. 

Compensation will include base, bonus, stock option along with relocation and is commensurate with industry standards.

Director of Clinical Affairs

Our client, a well known manufacturer of Medical Device and Pharmaceutical related products seeks a Director of Clinical Affairs. 

The Director, Clinical Affairs is responsible for the management of all clinical affairs for the Company’s products, as well as supporting marketing and other product management activities.  The Director, Clinical Affairs works closely with other internal departments and external parties (such as distributors and industry collaborators) to meet the clinical, marketing and product management goals for the Company’s products. 

Essential Job Functions:

• Manage the clinical affairs and marketing interaction and relationships with distributors of the Company’s products. 
• Process customer feedback and review product complaints in conjunction with Quality and Regulatory Affairs.
• Develop and deliver external training for distributors and customers.  Attend trade conferences to demonstrate and promote the Company’s products.  Manage all the activities related to the Company’s participation in trade events.
• Review product labels, promotional materials and advertising campaigns for the Company’s products, in conjunction with Regulatory Affairs, to ensure compliance with relevant regulations.
• Develop protocols and manage clinical user evaluations for the Company’s products.  Liaison with and support customer clinical affairs personnel conducting clinical trials.
• Seek opportunities, negotiate agreements and manage independent clinical trials and evaluations.
• Assess the market potential of new product opportunities and provide feedback into new product designs by conducting market research and determining user requirements for new products.  Perform market research into pharmaceutical uses and requirements and market potential of various uses.
• Represent clinical affairs and marketing on cross-functional teams for the Company’s products.

• React to change productively and handle other tasks as assigned, including working with department head and peers to improve all aspects of the department in support of business plans and support peers and immediate supervisor by anticipating problems, offering solutions and continuously improving the function of the department.

Education/Experience Required:

Bachelor’s degree in nursing (or certification as a Registered Nurse) or certification as a Certified Nurse Practitioner (and/or Master’s degree in nursing) preferred.  Bachelor’s degree in a related field with clinical experience will be considered.  Five (5) years experience in a marketing, clinical and product management roles in the medical device industry required.  Experience conducting clinical trials and knowledge of clinical trial protocols in the United States and European Union required.  Previous experience managing clinical affairs for a medical device or pharmaceutical company specializing in injection devices, syringes or injectable products preferred.  Bilingual language skills highly preferred:  German or French.

Compensation will include base, bonus and stock options and commensurate with industry standards. 

Director New Product/Business Development & Commercialization

Our client, a well-known growing manufacturer of Oral Care Products seeks a Director New Product/Business Development & Commercialization.

This is a key position, which will be responsible for leading all marketing and commercialization aspects of new product development for the Oral Care categories, from the generation of new pharmaceutical product concepts through product launch.  This will include outlining the strategic framework, developing and validating concepts, and developing and coordinating the implementation of go-to market plans.

Key Experiences:

• Pharma or OTC Drug or Health & Beauty Care experience mandatory, with chemical and monographed products.  Dental experience a plus.
• 8+ years marketing, including new product management
• Experience marketing to retailers and professionals
• Experience managing web campaigns
• Success selling direct to consumer via Internet, DTC or other
• Experience writing new product concepts
• Experience developing sales training materials
• Experience leading cross-functional project teams
• Experience managing and developing direct reports

Essential Duties and Responsibilities:

Demonstrated ability to conceive, develop and implement commercial strategies and convert these into tactical marketing plans, which deliver results.

Lead the development and implementation of commercially impactful new business/category/product concepts that align with the overall strategic vision for company including Canada, Latin American, and the U.S. 

Identify new product needs/concepts, determine segmentation, positioning and packaging requirements, launch and multi-generational product plans.

Identify unmet needs using pertinent research tools and push to create new categories/products.

Determine how to motivate target consumers and professional (e.g., dentist) to purchase/use/endorse.

Strong leadership presence and collaboration skills to drive alignment of multifunctional teams developing and launching new products. 

Will manage periodic engagement and alignment with other business units globally.

In return, they offer a highly competitive salary, an excellent benefit package and significant challenge and opportunity for growth and advancement. 

Product Manager

Our client, a well-knnown manufacturer of BioProcessing and Medical Device Products, is currently seeking a Product Manager.

Job Summary: The Product Manager position champions the processes involved in bringing products to market and are highly empowered drivers of their business area.  Product Manager will work cross-functionally internally and externally with customers and industry thought leaders to assess the process and technology needs of the marketplace and the underlying assumptions that are broadly held.

Duties and Responsibilities:

• Optimize business performance of product lines by developing product positioning, implementing marketing plans and sales education programs.  Provide product and market knowledge to support sales activities through customer and end user visits.
• Responsible for translating customer voice into new product development needs.  Coordinates field trails, market surveys, customer focus groups and providing follow-up customer support in order to ensure an in-depth understanding of customer needs and potential opportunities. Monitor project plan to ensure accurate and timely completion is aligned with market timing, and compliance with customer requirements.
• Develop and drive new product launch plans including creation of content, sales tools coordinating development with marketing communications.
• Lead Product Lifecycle management and ensure overall product line health by meeting customer need within existing products by rationalizing SKU’s and introducing product extensions as well as new platforms.  Responsible for margin of product line with focus on revenue and margin growth within product segment.
• Optimize business performance via in-depth analysis of market and competitive environment, close monitoring of global pricing within major markets in order to optimize pricing and product positioning.  Develop strategy to meet Revenue growth targets by working with Sales, R&D, Operations and customers to identify obstacles.
• Lead the development and implementation of the marketing plan for products.  Work with Marketing Communications to ensure appropriate project planning and delivery of marketing materials.  Participate with cross-functional management and the sales teams in the review and implementation of the market plan for the assigned business area.  Propose marketing comminations mix and activities for product lines.

Education, Experience, and/or Skills Required for consideration as a Candidate:

• Bachelor of equivalent degree in business or a science discipline.
• 2+ years Product Management experience.
• Must be experienced and effective in working across boundaries and functions.
• Experience in new product launch activities with the ability to set effective pricing as well as analyze and define markets. 

Education, Experience and/or Skills Preferred:

• MBA preferred.
• 1 to 2 years experience in Medical Device, Life Science or Biotech environments.

Competencies (if applicable):

• Demonstrated verbal, written, and interpersonal communication skills, including the ability to work cross-functionally.
• Demonstrated knowledge of personal computer software in a business environment, including email, word-processing, spreadsheet, and database applications.
• Good organizational skills, including the ability to be flexible to changing priorities and needs.  Demonstrated attention to detail and accuracy combined with proven ability to multi-task.

Compensation will include a base, bonus and excellent benefit package and is flexible depending on experience.

Manager of Specialty Pharmacy Contracting

Our client, a well-known Healthcare company, seeks a Manager of Specialty Pharmacy Contracting. 

The Specialty Pharmacy Manager executes operational objectives by providing integrated pharmacy services for customers and business partners. 

• Leading and implementing specialty pharmacy initiatives in the manufacturer and distribution contracting processes within the specialty pharmacy environment
• Working collaboratively with multiple internal and external partners, including trade relations, corporate procurement, health analytics, and pharmaceutical companies
• Ensuring documented project policies and processes are followed
• Participating in strategic planning for the pharmacy organization and the trade relations group
• Contributing to various trade relations group responsibilities as assigned
• Developing strategies, solutions and processes by understanding the initiative and the audience

Key Competencies:

Acts Strategically

Execute Problem Management Skills

Demonstrate Excellent Communication Skills

Role Essentials:

• Development / management of programs that reach measureable qualitative and financial metrics
• Strong written and oral communication skills
• Strong detail orientation skills
• Strong background in financial analysis and contract negotiation
• 3-5 years experience in the specialty pharmacy contracting environment
• Project Management and implementation skills
• Strong in PC based Microsoft applications including Word, Excel, and PowerPoint
• Ability to learn quickly, work independently and excel in a team environment

Role Desirables:

• Knowledge of specialty pharmacy, distribution and revenue opportunities

Reporting Relationships

• Reports to the Director of Trade Relations

Compensation will include a base in the $130 - $140,000 area, plus bonus and excellent benefits.

Director of Sales

Our client, a well-known Chicago based provider of Infusion/Home Care Services seeks a highly skilled Director of Sales.

This person will be responsible for growing clientele through strong, existing relationships in the healthcare community as well as developing new client relationships within various product lines.  The Director of Sales will be extremely familiar with the healthcare community and will interface with mediation and healthcare experts in the field in order to drive new business.  They will lead all aspects of building and maintaining a sales pipeline.  The Director of Sales will be tasked with building a sales team, providing sales training, motivating the team and acting as a mentor by leading the career development of their team. 

The Director of Sales will have a long history of growing new business within the Healthcare Industry, Home Infusion/Specialty Pharmacy, and Home Care Services, along with strong technical knowledge, setting and achieving sales goals, motivating a sales team, excellent oral and written communication skills. 

This position will report to the Chief Operating Officer.

Duties and Responsibilities:

• Build, train and lead entire sales team
• Ensure sales team is meeting quarterly and annual sales targets
• Increase sale by opening new accounts as well as maximizing revenue from existing clients
• Create an efficient territory schedule to ensure regular client visits, and effective prospecting
• Evaluate market trends and provide analysis and recommendations to executive team
• Schedule and manage regular company sales meetings
• Utilize available sales and marketing tools for presentations, sales calls, and prospecting
• Promote full range of offering to existing and potential clients
• Maintain a strong network and relationships within the local market in order to leverage appropriate market influencers and provide expertise to the industry.

Requirements:

• Must have proven track record of success in new client generation in the healthcare industry.
• Must have experience building a sales team – both local and multi-region.
• Successful track record in sales management with home infusion organizations
• 4 Year Business Degree from an accredited University
• Demonstrated Success in B to B contracting with Health Plans and Hospital Networks

Compensation include base, bonus/commission/car program, along with excellent benefits.

Marketing Director

Our client, a leading Chicago based Healthcare company seeks a Marketing Director to support their regenerative products business.

The Marketing Director will lead the strategic planning and execution of the business plan to achieve the company’s sales objectives.  Critical to this success is the development of a strong program which will result in 3 presentations per month, 1 national symposium, 5 web based surgical training programs and 10 published case studies.  In addition, the Marketing Manager will provide market and competitive analysis, plan and execute new product launches, develop sales collateral and marketing support materials, create and implement trade advertising and act as the operational interface for all projects. 

The ideal candidate will have a Bachelor’s Degree in Marketing or related area.  Must have minimum of 4-6 years experience in medical product or dental product marketing.  Experience in the dental implant/regenerative field is highly desired.  Ability to successfully manage your own business, and lead projects to completion on-time/on-budget, is essential. 

They offer a highly competitive starting salary and an excellent benefit package. 

Director of Qualty & Regulatory

A well known $150 million Chicago based manufacturer of Healthcare Products is currently seeking a Director of Quality & Regulatory .  This individual will design and implement a Total Quality Management system for the U.S., Canada, Mexico, and Latin American business, to ensure supply and distribution of products in conformance with all local regulatory, business, and customer requirements, by performing the following duties personally or though subordinate supervisors and staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned.

• Prepares, or directs consultants in preparation, of required regulatory filings, including 510k for U.S. FDA approval.  Works to ensure required registration of products for all countries in which they operate.

• Develops and maintains quality system to comply with U.S. FDA Quality System regulations and international ISO 9002 requirements.

• Train and direct technicians engaged in inspection and testing activities at remote facilities to ensure continuous control over materials, facilities, and products.

• Formulates and monitors quality measurements and objectives and coordinates CAPA and quality improvement efforts throughout the company in cooperation with other managers to maximize product and service reliability and operational efficiency and effectiveness.

• Leads Complaint Review Meeting and Quality System Review meeting; manages relationship with external quality auditors; facilitates cross-functional problem solving and quality improvement teams.

• Design and conducts training activities related to quality and regulatory.

• Investigates and responds to issues of customer complaints regarding product quality.  Manages complaint reporting and analysis process and coordinates internal and external activities related to CAPA.

• Works closely with manufacturing facilities, as well as other product and parts suppliers to ensure compliance with company’s quality system and regulatory requirements.

SUPERVISORY RESPONSIBILITIES

Manages exempt and nonexempt employees in the Quality Department.  Is responsible for the overall direction, coordination, and evaluation of this unit.  Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complains and resolving problems.

EDUCATION

B.S. or B.A. in engineering or related technical discipline; Certified Quality Manager (CQM) or Certified Quality Engineer (CQE).

EXPERIENCE

Five to seven years related experience in Quality / Regulatory Management in an FDA-regulated environment.

Product Marketing Manager

A leading Chicago based Consumer Products Healthcare company is currently seeking a Product Marketing Manager Canada.  This individual will develop, implement and control product marketing plans and trade marketing plans that are linked to the strategy and supported by marketing research or consumer insights for the Canada region.

Essential Duties and Responsibilities include the following:

Create and develop comprehensive marketing plans for existing and new products across all categories in conjunction with the product marketing team.  Marketing plans will include: market analysis of the company and competitive products and strategies; product and market analysis of strengths, weaknesses, opportunities, and threats; defining objectives that are consistent with long-term growth and profitability goals; development of strategies and tactics to achieve financial goals, and formulation and coordination of promotional programs.

Launch new products, which will include: understanding customer and sales force needs via effective market research; product definition and development; translating research results into viable new products, line extensions, and/or product launches by market segment; developing product training materials for customers and staff; evaluating customer and sales force feedback on products; and providing marketing input to product development teams to define customer functional requirements.

Create plans for all product lines in Canada, including driving annual and strategic mid-term planning process; providing vision and establishing long-range goals; preparing operating plans to include sales forecasts and expense budgets; and supporting forecasts and budgets with appropriately detailed marketing plans. 

Enhance sales/profit and manage cost recovery, including: analyzing sales trends and impact of competitor products; reviewing and analyzing monthly sales performance; offering proactive solutions to detrimental sales trends; reviewing all levels of production cost and working actively towards lowering them; and managing inventory to optimal levels by identifying and taking action on slow-moving or obsolete products and/or parts. 

Support the Sales and Consumer Services functions by: working regularly with Sales in their accounts and at trade shows; meeting regularly with Sales staff; developing and executing trade marketing plans; supporting Sales through support and information to Customer Services; communicating new product information, product availability, inventory status, pricing updates, and competitive information to Sales force.

Education

Bachelor’s degree from four-year college or university, or equivalent experience; MBA preferred.

Experience

Three to five years related marketing experience.  Experience in Canadian retail markets preferred.

Compensation

Clinical Manager

Our client, a well known Chicago based manufacturer of Medical Devices and Pharmaceutical Products seeks a Clinical Manager to ensure the development and commercial production of products, Class II and III medical devices and pharmaceuticals, complying with QSR, ISO13485, cGMP, GLP, GCP and other relevant requirements.  Perform the preparation and completion of all clinical studies in cooperation with Investigators, CRC and CRO, data management, data analysis and document preparation related clinical study to be submitted to FDA and collaboration with R&D, Engineering, RA and QA team.  Also take initiative and facilitate the promotional clinical case studies (open studies) as well as RCT (randomized control trial) type studies for company’s products.

Principle duties:

• Take initiative and leadership and facilitating all product clinical studies
• To investigate regulatory guidelines and requirement for clinical study in collaboration with RA manager, regulatory consultants and CRO’s.
• To develop clinical protocols, packaging and labeling for investigational product in collaborating with R&D, Engineering, RA and QA team.
• To coordinate study meetings with investigators and CRC in cooperation with CRO.
• To educate and train clinical investigators in cooperating with CRO to comply with GCP, ICH and other regulatory standard.
• To communicate with and reply to FDA regarding investigational clinical studies in order to obtain FDA approval.

• Supervising monitoring activity and data management and analysis in clinical study
• To take responsibility of supervising monitoring activity of CRO performed at clinical sites.
• To take responsibility of supervising clinical data management and analysis handled by CRO.
• To take initiative to coordinate DMC meetings periodically and/or according to the request by DMC members.

• Taking initiative and leadership and facilitating to establish internal system complying with GCP, ICH and other regulatory standard
• To educate and train internal CRA to comply with GCP, ICH and other regulatory standard.
• To take responsibility of archiving clinical study documents.

Job Responsibilities:

This position reports to Director, Product Development and Technology.  To establish enough knowledge about the company’s products to manage clinical studies.  To establish a good communication with Investigators, CROs and FDA.  To enable 1-2 week business trip to inside or outside of the U.S.

Requirements:

BS or higher.  A minimum of 5 years clinical study managing experience in pharmaceutical or medical device, including a substantial handling PMA.  Basic understanding and experience in biostatistics.  Good at English writing and editing for regulatory documentation using Word, Excel, PPT, etc.

Compensation includes base, bonus is flexible depending on experience.

New Product Development Engineer

Our client, a well-known manufacturer of Medical Products, seeks a New Product Development Engineer.  This person will be responsible for developing products, processes and technologies, which increase sales and improve profitability and product quality.

Duties and Responsibilities:

• Understands and adapts to market needs for new products.
• Identifies and evaluates new materials, components and technologies.
• Leads and participates in multidisciplinary product launch teams.
• Adheres to Design control and Stage gate processes.
• Documents activities, experiments, trials, samples and ideas in a research laboratory notebook.
• Updates project progress to key stakeholders.
• Documents and keeps records for all project proposals, activities, experiments, trials, samples, ideas, etc. for future reference.
• Understands Patent positions of new and/or existing technology.
• Prioritizes activities with manager and business team and direct efforts accordingly.
• Accurately scopes time and budgets of projects.  Completes projects on time and within budget.
• Organizes, executes and reports in depth technical evaluations of competitive products.
• Actively works to transfer design to manufacturing at the appropriate time.
• Responsible for producing product samples.
• Must be knowledgeable in the effective use of Lean Six Sigma (LSS) tools and concepts to assist in process improvements.

Ideal candidate will have a minimum of 3 years in New Product Engineering within Medial or Bioscience products.  Additionally, this person should have a BS in Science, Engineering, or Technology. 

Compensation is flexible depending on experience.