Career
Job Summary:
The Business Development VP will be able to present and promote services and solutions to potential clients including new accounts, new business opportunities at existing accounts, and new marketing opportunities with the objective of establishing long term, mutually beneficial business partnerships.
Responsibilities:
- Serve as leader in developing new business and strategic partnerships
- Foster, promote and facilitate expansion of company-wide products, services, and capabilities.
- Collaborate with colleagues (executive, leadership, and peers) to develop new products and services.
- Contribute to the strategic planning and execution of all sales, marketing, and public relations activities.
- Ability to establish a strong communication link and credibility with client management teams through the highest level of professionalism, ethics, integrity, mutual respect, and value-added approach.
- Bright, quick, articulate, excellent presentation and interpersonal skills, and able to adapt to different internal and external constituencies.
- Viewed as a team player who also possesses the independence of thought and opinion to provide candor and honesty when making key business decisions.
- Passionate about business results, with a strong sense of accountability, metrics and ownership. - Strong organization and prioritization skills.
- Bachelor’s Degree acceptable, Masters level Degree preferred
- Minimum of 10 years business development experience where the candidate demonstrates the ability to directly impact overall business success through corporate development, strategic alliances, and partnerships
- Must have experience in a service BD environment, not just product BD
- Ideal candidate will have small company experience
- Experience in the CMO, CRO, CDMO or tech service BD roles with strategic alliance component will be given preference.
Job Summary:
The Business Development Director effectively identifies and pursues new and existing business opportunities while enhancing relationships with existing clients, keeps abreast of industry trends, competitors’ services and acquisitions, and works in conjunction with leadership to develop and respond to new and existing business development opportunities. The Business Development Director will develop short and long-term BD strategies within their assigned territory and/or account list. The Director, Business Development, will enter all client information into recruit and other company systems and will work effectively with all internal functions to drive sales.
Responsibilities:
- Introduce and maintain long-term client relationships resulting in the expansion of client base
- Directly implement initiatives to help build awareness of Advanced Clinical capabilities and services
- Discover immediate needs of target market through leads and follow-ups, executing internal and external initiatives to drive bookings and profitable growth
- Use of prospecting tools, sources of industry information, referral networks, and personal relationships to directly research, target, and approach new business opportunities. Must be comfortable “cold calling” and strategically prospecting within new accounts.
- Support direct sales by creating and participating in sales meetings, presentations, and the Proposal process
- Schedule meetings with current and potential clients at industry meetings and trade shows and generate associated follow up
- Track and monitor adherence to the client contracting process
- Work collaboratively with all functions that support Business Development, inclusive of proposals, legal, finance, and all functional leadership, promoting a team-selling environment
- Adhere to Advanced Clinical employee handbook and SOP’s
- Adhere to strict code of confidentiality as it relates to study subjects, sponsors, physicians, and policies and procedures of Advanced Clinical
- Provide excellent customer service to all parties involved in the clinical study process
- Bachelor’s degree (or equivalent) in business or healthcare related field
- 3-5 years of business development experience within a CRO and or clinical trials environment
- Experience across CRO, FSP, and Staffing business development with the ability to understand the differences in sales cycles and customer interactions
- Consultative and collaborative approach when dealing with customers and internal team members
- Present a professional company image and presence
- Outstanding organizational and communication skills with ability to effectively communicate and sell his/her ideas at all levels. Listens well and seeks input from others.
- Proven ability to generate new ideas, processes, and strategies to improve the department and ensure the success of sales for the company
- Knowledge of the industry, inclusive of competitors
- Computer skills including Microsoft PowerPoint, Word, Excel, and Outlook
Job Summary:
The Laboratory Director will perform monitoring and site management activities for clinical research projects to assess the progress of clinical projects and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable local and federal regulatory requirements. Performs all tasks routinely and independently. Mentors and/or trains, as well as may assume line management responsibilities for less experienced employees. May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a project.
Responsibilities:
- Leads and manages all laboratory staff, for both the biomarker and safety laboratory operations and deliverables
- In conjunction with Clinical Sciences staff, develops biological markers of pharmacodynamic and effect and disease models to support new drug development in humans and to support regulatory filings.
- Leads the development, validation and performance of biomarker methods and routine clinical safety analyses to support the clinical development of drug candidates.
- Develops and maintains quality processes and SOPs in the laboratories, ensuring that all temperature records, calibrations and certifications of instruments and equipment are sustained.
- Develops and enforces policies to assure biological, chemical, and general safety in the labs.
- Assures accurate collection and processing of biological specimens to assure quality of analytical data.
- In conjunction with the Medical Director and Groton Clinical Sciences, establishes policies on scientific and operational practices and assures exemplary scientific and ethical standard.
- Assures compliance of all activities with applicable regulations and guidelines.
- Delivers high quality, validates methods and laboratory data to Groton Clinical Sciences.
- Recruits, trains, appraises, and provides for career counseling / development of staff including continued competency.
- Develops and maintains unit capability by assuring that facilities and equipment are properly maintained, validated, and periodically updated.
- Involved in the creation and implementation of global and local SOPs, ensuring staff are trained.
- PhD in chemistry or the biomedical sciences preferred.
- Previous direct work experience (5+ years) managing a laboratory in a health care or pharmaceutical setting; expected experience in analytical techniques and full knowledge of analytical validation procedures.
- Experience with clinical trial operations.
- Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
- Demonstrated leadership ability and supervisory experience.
- Good interpersonal skills.
- Through knowledge of OSHA requirements related to safe operation of laboratories.
- Thorough knowledge of clinical pharmacology and regulatory requirements (GCP, GLP, CLIA).
- Experience leading teams and motivating direct and indirect staff
- Proven ability to accept, accommodate and manage change in a fast-paced high-stress setting.
Job Summary:
The Project Manager ensures client deliverables are met on-time, within scope, and within established quality standards. This position regularly interacts with clients for current studies and potential future studies awarded.
Responsibilities:
- Responsible for client interaction and the conduct of studies.
- Responsible for data interpretation, analysis, and reporting of results for bioanalytical method development and validation.
- Responsible for the management of preclinical and clinical sample analysis using bioanalytical methods.
- Maintains and applies experience and knowledge of ligand-binding assays (e.g. ELISA / MSD) applicable to Pharmacokinetic, Biomarker and ADA studies to support existing and new client studies.
- Integrates bioanalytical contract research organization (CRO) business objectives in daily activities.
- Maintains knowledge and applies regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation and sample analysis.
- May mentor, train, or supervise new or less experienced team members.
- Participates in or contributes to business initiatives, such as process improvement, quality, culture, etc.
- Adherence to laboratory health and safety procedures.
- Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines.
- B.S. / B.A. degree in Biology or related field and a minimum of 10 years of relevant experience in the CRO industry; or advanced degree in Biology or related field and at least 5 years of relevant experience in the CRO industry.
- Knowledge of GLP regulations and regulatory guidelines.
- Excellent communication skills, both oral and written.
- Strong leadership and organizational skills.
- Excellent organizational skills.
- Proficient in the use of basic computer applications such as MS Word and Excel.
- Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.
- Proficient in time management and resource planning.
- Ability to effectively interact at all levels of the organization in addition to with clients and regulatory personnel.
- Ability to make decisions and complete assignments with minimal guidance.
- Ability to establish work priorities and manage shifting priorities.
Job Summary：
Looking for an HR manager: (1) a hands-on HR professional with diverse experience across the HR spectrum, specifically including Recruitment experience; (2) previous Pharma/Biotech experience; and (3) a desire to help HR prepare for and handle a lot of growth.
Responsibilities：
- Development of an employee-oriented company culture that emphasizes quality, continuous improvement, key employee retention and development, and high performance.
- Work closely with management and employees to improve work relationships, build morale and increase productivity and retention
- Provide HR policy guidance
- Designing employees’ compensation and benefits packages
- Monitor and report on workforce and succession planning
- Provide management with requested reports and documents.
- Coordinate events focused on employee recognition.
- Accurately maintain employee files.
- Plan attractive compensation and benefits packages to increase retention
- Onboard and train new hires
- Manage payroll considering overtime, flexible schedules, and seasonal employment
- Ensure relevant local policies are designed and managed in line with national policies and legislation
- Track recruitment KPIs and suggest improvements, as needed
- Design and implement company policies that comply with our business objectives
- Ensure all HR operations adhere to legal standards
- Collaborate with plant leadership members in identifying the people and organizational implications and coming up with appropriate solutions to address business needs and root causes of the problems
- Bachelor’s degree in Business Administration or Human Resource Management
- Knowledge of employment and wage laws
- Knowledge of OSHA
- ADP Experience
- Recruiting Experience
- Manufacturing Experience
- 5+ years of working experience in Human Resource Management
- Designs, plans, and implements human resources programs and policies
- Track recruitment KPIs and suggest improvements
- Labor law knowledge skills
- Proven leadership in labor relations, including grievance and arbitration administration and contract negotiations
- Organizational Growth and Employee Relations
- In depth understanding of organizational development, compensation, staffing, training, performance management, and employee & labor relations functions
- Proficient in PC applications, MS Word, Excel, PowerPoint etc
Job Summary:
Responsible for the conduct of method development, method validation and the analysis of samples using immunoassay methods, including ELISA, MSD, Cell based assays and others, in support of regulated pre-clinical and clinical bioanalytical studies for drug development programs.
Responsibilities:
- Able to lead and direct scientific work to support external methods and projects.
- Maintain up to date knowledge of scientific advances, analytical techniques, instrumentation, methodology, regulatory compliance, and industry guidelines relevant to bioanalysis.
- Develops and reviews protocols and sample analysis plans.
- Reviews method development data to ensure methods are ready for validation.
- Approves validation methods and reviews sample analysis methods.
- Independently reviews and approves raw data.
- Reviews and approves reports for scientific accuracy and completeness.
- Serves as a point of contact for the client.
- Works with the client to determine project requirements.
- Provides a technical resource for less experienced team members.
- Ensures that any circumstances that may affect the quality and integrity of the study are identified and documented as they occur, and appropriate corrective action taken.
- Provides appropriate coaching and recognition to team members.
- Able to plan, prioritize, and manage workload for large and complex projects.
- Ph.D. in Immunology/Immunochemistry or related discipline, M.S. degree in Immunochemistry or related discipline with 3+ years of experience or B.S. degree with 6+ years of directly related experience and/or equivalent work experience in an appropriate scientific discipline
- Excellent communication and interpersonal skills
- Excellent attention to detail
- Able to utilize word processing, database, spreadsheet, and specialized software
- Experience and skill with Watson, Nautilus, and Analyst preferred
- Knowledge of regulatory agency guidelines
Job Summary:
Working as part of our growing Immunology department, you will undertake routine analysis of pre-clinical and clinical samples for the Immunoassay section. Conduct analytical method validation and assist in analytical method development. Check analytical data, coordinate equipment maintenance and servicing and be involved in the training of junior staff.
Responsibilities:
- Develop and/or optimize analytical immunoassays and procedures with assistance commensurate with demonstrated proficiency level, for example, antibody characterization, titration, or buffer optimization.
- Generation of high quality of analytical results to support formulation or process development studies.
- Documentation in accordance with good manufacturing practice (GLP) guidelines using electronic systems.
- Preparation of technical reports, standard operating procedures (SOPs), Assay Procedures, and Development Memos as needed.
- Experience with immunoassay method development and validation.
- Attention to detail and used to working to tight deadlines.
- GLP or other regulated experience.
- Applied experience with ELISAs or similar technologies.
- Assay development.
- Experience or knowledge of general antibodies/immunoassays (non-cell based)/ PK ADA.
Job Summary:
The Specialist responds to end-user service requests in a timely manner; completes requests to add/move/change user accounts and workstations; addresses issues with corporate systems such as printers, phones, and audio-visual (AV) equipment; and supports projects related to the overall corporate infrastructure and validated computerized systems.
Responsibilities:
- Administrate user accounts for network, e-mail, and other applications.
- Provide support to end users on our IT equipment and software applications including computer hardware, peripherals, copiers, fax machines, mobile phones, scanners, building security systems, environment monitoring systems, computer operating systems, office applications.
- Identify, research, and resolve technical problems of IT equipment and software applications.
- Respond to IT tickets, telephone calls, e-mails, and requests for technical support; and
- Document, track, and monitor problems to ensure timely resolutions.
- Bachelor's degree in Computer Science or related discipline
- Associate degree in Computer Science or Information Technology.
- At least 1 year of experience in a help desk or IT Support role.
- Experience with Exchange Server Tools, Office 365 and another cloud-based application
Job summary:
Assay Development Associate Scientist may supervise one or more Research Associates in the development and validation of immunoassays, showing strong decision-making abilities in their area of expertise. They create a development strategy for their own developmental projects as well as the projects assigned to their direct reports, designing experiments, troubleshooting problems, organizing, and interpreting experimental results and performing follow-up experiments. Their ability to perform sophisticated technical tasks allows them to pursue projects that incorporate a diverse set of skills and work on multiple projects/experiments simultaneously.
Responsibilities:
- Designs and executes immunoassays (e.g., ELISA) independently, based on protocols provided by literature, seminars, and other scientists. Troubleshoots assay-related problems with no guidance of his/her supervisor and performs follow-up experiments. Suggests modifications to protocols or alternative protocols.
- May supervise one or more Associate level scientists in the development and validation of immunoassays to support new programs.
- Routinely performs multiple assays within the same day and can work on multiple projects simultaneously.
- Summarizes and presents results to supervisor in a logical manner, verbally and in written reports or presentations. May present data to senior management.
- Independently develops immunoassay methods and writes assay validation protocols.
- Expertly performs validation experiments, summarizes results in a tabular manner. Writes/reviews validation reports.
- Trains other lab personnel on his/her area of technical expertise. Serves as a role model and mentor within the group.
- Communicates effectively with supervisor and other members of the Assay Development Group. Communicates with other groups within the company and/or outside vendors to obtain assay-related reagents or discuss reagents needs.
- May participate in multi-disciplinary meetings such as joint project teams as Assay Development representative to help direct drug development programs.
- May evaluate new technologies for the development of immunoassays using new formats or techniques.
- Maintains GLP compliance for all laboratory work and documentation related to assay validations in accordance with FDA regulations and company SOPs. Assists in maintaining GLP compliance in the laboratory.
- A PhD degree
- A minimum of 2 years of post-degree laboratory experience.
- Experience developing and/or validating pharmacokinetics (PK), biomarkers and/or immunogenicity (ADAs and NAbs) assays is preferred.
Job Summary:
Responsible for acting as a finance team business partner, working with other departments within the organization, to ensure the accuracy of accounting records, assisting in the compilation of forecasting/budgeting, and performing results analysis’ for management review.
Responsibilities:
- Review all clinical agreements, including but not limited to CRO contracts, consultant contracts, protocols, investigator clinical trial agreements, laboratory service providers and supporting technology platforms.
- Review Purchase Orders for completeness
- With oversight, perform month-end close responsibilities including posting journal entries to the general-ledger and performing account reconciliations.
- Analyze the sufficiency of accrued liability account balances
- Review vendor requests for payments against contracts and work performed.
- Monitor and communicate spend/expense recognition against open purchase orders.
- Prepare monthly results packages (i.e. budget-to-actual analysis, trending analysis, etc.)
- Participate in the implementation and maintenance of accounting systems and other technology platforms and improvements.
- Other projects as deemed appropriate.
- Bachelor’s Degree in Accounting, Finance or equivalent required, Advanced degree or training a plus, (CPA, MBA, Certificates.)
- Solid understanding of drug development and clinical operations; well-versed in understanding clinical service provider budgets and associated payment terms.
- Ability to learn, understand and apply new technologies.
- Excellent internal customer service skills.
- Ability to multi-task/ prioritize and time management of daily activities
- Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
- High attention to detail
- Demonstrates high level of accuracy and effective oral and written communication skills.
- Excellent ability to work in a goal and team-oriented setting.
- Well-developed organizational skills and the ability to thrive under pressure