• Project Manager
  

• Manages one or more high-level, complex non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements. 
• Projects may be strategic in nature. Responsibilities may include resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, ROI, business plan, design, testing, and implementation planning). 
• Regularly interacts with management. Coordinates and directs the activities of project team members. 
• May be responsible for cross-functional teams. 
• Ensures all project requirements and/or objectives are documented. 
• May obtain and manage external resources required for project completion
  

• Expertise in running medium to large scale projects
• Excellent understanding of project management processes and procedures
• Experience with project management and analyst methodologies and best practices; strong analytical skills; business process development best practices, change management
• Strong MS Project, MS Word, Visio, MS PowerPoint and MS Excel skills
• Understanding of systems for sharing and collaboration; excellent communication skills to work with cross-program resources
  

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Program Manager

Position Description

• Understand and follow current activities and trends in the biotechnology/pharmaceutical industry
• Partner with Medical Affairs Leadership and Field Teams to support the business and its operations in continuously identifying opportunities for improvements
• Ensure that all business processes and solutions identified reflect best practices and ensure competitive advantage
• Support ongoing Medical Affairs operations to reflect business priorities
• In conjunction with Medical Affairs, create an overall strategic roadmap, including conducting cross-functional impact assessment and defining new initiatives to ensure long-term sustainability and success
• Develop and manage detailed program plans for all initiatives including: charter, objectives, activities, timeline, deliverables, resources, roles and responsibilities, milestones, success metrics, impact analysis, issue/risk management, etc.
• Identify, align, and involve all key internal and external partners/stakeholders in each initiative
• Drive cross-functional initiative teams and manage key internal or external partners to achieve targeted success metrics and complete deliverables on time and within budget
  

Position Requirements

• Impeccable ethics and integrity

• Strong analytical skills and capabilities

• Demonstrate program management skills

• Coordinate and manage multiple initiatives

• Proven ability to manage multiple tasks to conclusion, on time, and without compromise to quality of work output

• Excellent communications skills, both written and verbal including facilitation and presentation in group settings

• Ability to influence others without authority

• Exceptional partnering skills by working collaboratively and effectively with internal and external stakeholders

• Education: -Bachelor’s Degree (Business Management, Life Sciences, or other technical discipline)

• MBA or other related graduate-level degree is preferred

• PMP Certification is preferred

• 4 years or more multi-disciplinary experience in the pharmaceutical/biotech/healthcare or other related industry

• Previous work experience gained in Medical Affairs is strongly preferred
  
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Manager, Clinical Pharmacology
  

Position Description

• Responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to LWT and GWT for multiple drug development programs with minimal management supervision. 
• Responsible for clinical PK/PD study design, protocol preparation, implementation, data analysis and study report preparation.
• Responsible for managing the activities of personnel associated with conduct of Clinical PK/PD studies and assurance of compliance with SOPs, and FDA and ICH regulations. 
• Responsible for preparation of PK/PD components of Briefing Documents, INDs and NDAs.

Position Responsibilities

• Provides PK/PD input to the strategic development plans for multiple drug development programs with minimal supervision from department management.
• Designs and prepares protocols for clinical PK/PD studies with minimal direction.
• Provides input in making site selection decisions; assesses overall site quality on an ongoing basis; helps resolve site problems; supports CRAs and Sr. CRAs on site-related issues.
• Evaluates clinical study resources and proposes changes as necessary. 
• Prepares CRO and site budget proposals.
• Monitors expenditures and payments.
• Performs clinical PK and PD data analysis using a variety of software programs and using external resources as necessary.
• Manages projects to ensure completion to meet established objectives in accordance with SOPs and FDA/ICH requirements.
• Coordinates internal resources (e.g., drug supply, data management, biostatistics); forecasts and manages drug and drug supply needs for development programs. 
• Provides interim reports to Biopharmaceutical Sciences management and project teams regarding subject enrollment and overall study conduct.
• Prepares and reviews study reports for completed PK and PD studies. 
• Prepares and reviews PK and PD components of study reports for completed Phase II/III studies.
• Prepares the PK/PD components of Briefing Documents, INDs and NDAs with minimal supervision from department management.
• Participates in project reviews and presents study status and results to management. 
• Attends professional meeting and presents study results as appropriate. 
• Publishes study results as appropriate.
• Understands SOPs, regulations/guidelines governing drug development (FDA, ICH, cGCP) and ensures that they are followed.
• Training. Participates in on-going training and in the training of Sr. CRAs, CRAs and Clinical Research Specialists.
• Duties as assigned by supervisor. 

Position Requirements

• PhD, Pharm.D, MS, BS in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis. 
• Five years of Phase I clinical trial experience or equivalent.  
• Knowledge of Clinical Research Organization industry for clinical trials. 
• Knowledge of drug development process and ability to design and implement Clinical Pharmacology development plans.
•  Proven project and time management skills 

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

• Clinical Trial Manager
  

• Manages all aspects of an assigned clinical program(s) (globally) to ensure that all studies within the program are completed on time within budget and in compliance with SOPs, Regulatory regulations and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals.
     

• Uses knowledge of therapeutic area and TA strategies and operational expertise to oversee the Clinical Sub-team for assigned molecules, takes a leadership role in the implementation/ execution of the CDP, and participates in the development of clinical trial protocol concept in collaboration with the sub-team.
  
  
• Utilizes operational expertise, knowledge of TA strategy and TA scientific input when planning program feasibility, developing strategies for country selections, CRO/ vendor use and evaluations and planning for contingencies. May participate in business development evaluations from the clinical research and operational perspective as applicable.
  
  
• In conjunction with the sub-team, contributes to creation, implementation and revision of the CDP; evaluates and ensures that CDP is feasible, (i.e., that the key clinical development milestones are achievable within the constraints of the available human resources and the proposed budget and timelines) and oversees implementation of CDP into study protocols.
  
  
• Establishes and cultivates relationships with site investigators and Key Opinion Leaders, ensuring up-to-date knowledge of current clinical research landscape and operational feasibility in relevant indications and locations.
  
  
• In conjunction with the sub-team, coordinates all relevant Clinical Development activities/documents related to Regulatory Submissions (e.g., IB, IND, Annual Reports, BLA, NDA or other regulatory filings).
  
  
• Provides input into creation of program budget. Ensures Clinical Development portion of program is conducted within budget and identifies, escalates and/or resolves discrepancies.
  
• Tracks and oversees all studies related to the program's CDP(s). Ensures consistency within all program studies, alignment to overall time lines and budgets, TA strategies and corporate objectives.
  
  
• Provides mentoring, leadership and guidance to clinical trial management staff as well as direction and oversight on protocol development, associated clinical documents (e.g., CRFs, charters, etc.) and study execution, including ensuring that GCP principles are followed.
  
  
• Participates in recruitment, development, and training of trial management staff. May have direct line management of program-related Clinical Trial staff.
  
  
• Oversees the Clinical Trial Working Group (CTWG) strategy for site and vendor selection, and approves final investigator site and vendor selection for clinical trials at the program-level.
  
  
• Ensures consistency and GCP compliance within all program clinical trials, and ensures alignment with the therapeutic area and commercial strategy.

• BS/BA degree plus 8-10 years
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development;
  
• Excellent project management skills, including risk assessment and contingency planning. 
• Also requires excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills.
  
• Education typically requires 8 years of global drug development with experience managing clinical projects within time, budget, and quality expectations;
  
• Advanced degree preferred; excellent current knowledge of clinical research; monitoring experience desirable; NDA/BLA or MAA experience desirable.
   

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Clinical Research Scientist

Position Description

• Develop site management plans and participate in clinical study implementation in areas such as protocol development and writing, data report form design, study material management, literature searches, and adherence, data integrity and regulatory compliance. 
• Provide training to study site personnel regarding protocol, study requirements and SOPs. 
• May interface with CROs to conduct studies.
• Assist data management group with database design, data clean up, queries and data analysis. 
• Assist with review and interpretation of clinical studies results to determine investigational drug performance meets desired product label claims.
   

Position Requirements

• Minimum of BA/BS degree, advanced degree preferred. 
• 2-3 years+ in Clinical Research

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Clinical Study Manager, Oncology

Position Description

• Manages the conduct of clinical oncology investigations

Position Responsibilities

• Trains develops and supervises the Clinical Staff.
• Reviews and develops departmental SOPS
• Co-Monitoring when needed
• Participates in audits
• Assist with the preparation of regulatory documents
• Negotiates contracts and budget 
• Prepares and distributes monthly management reports, ad hoc reports, summaries, or analyses as require
• Provide supervision as needed to internal or contract personnel
• Preparation of department budgets, timelines, and project plans. 

Position Requirements

• A minimum academic degree in Nursing (R.N. or B.S.N.), Life Sciences (B.A. or B.S.), Pharmacy or Medicine. Experience requirements may be less with advanced degrees.  An advanced degree (M.S. or PharmD) is preferred. 
• 5-10 years experience of progressively increasing clinical research experience within the pharmaceutical industry, global experience a plus.
• Experience in drug development, especially FDA regulations and GCP’s or Associates of Clinical Pharmacology CRA certification.
•  Experience in IND/NDA/BLA submissions.
• Management of CRO’s 
• International experience and experience in Oncology highly preferred.
  
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

Position Description

• The Clinical Scientist position will work as a partner to the Project Physician/Director, aiding in development of clinical protocols and leading cross functional interaction for drug development. A Clinical Scientist will be an accomplished writer with the ability to succinctly compose scientific trial support materials and briefing books. The Clinical Scientist will also be a primary source of training materials in support of the program and will be involved in the delivery of these materials to the field monitoring force.

Position Responsibilities

• Serve as partner to Therapy Area leadership (Associate Directors, Directors, Senior Directors, and Therapy Area Heads).
  Support the Project Physician/Director in the development of clinical trial protocols and drug development.
  
• Contribute to the development and delivery of Therapy Area and protocol specific training materials for use in training CRAs and for investigator meetings.
  
• Develop, with Clinical Project Managers, operational contingency plans and trigger points for these contingencies, based on potential outcomes and actual data e.g. Data Safety Monitoring Committees/Data Monitoring Committees.
  
• With Project Physician/Directors, personally interact with study site Pls and regional monitors prior to, during, and following study to develop a relationship and keep abreast of all study issues.
  
• Oversee trial execution for continued trial feasibility.
  Contribute to the development of eCRF/CRF and database structure and provide continuous data review as appropriate.
  Support Project Physician/Director and Medical Writing to generate IBs, CSRs, briefing books, annual reports, expert meetings, interim analysis, and Health Authority responses (with Regulatory).
  
• Prepare drafts of capsule summaries.
  
• Contribute to authoring and review of submission documents.
  
• Ensure consistent approach to database design, eligibility issues, and dose adjustment criteria across protocols in a program.
  
• Collaborate with GCS, Stats, and Clinical Project Managers & Physician/Directors to coordinate Clinical Supply Planning and the Clinical Supply Agreement (looking across an entire program).
  Collaborate with the CPM and the Project Physician/Director on SAE reconciliation.
  

Position Requirements

•  PhD/PharmD in Health Sciences, Nursing, or related field with 4+ years experience in clinical development environment OR  Bachelor's or Master's degree in Health Sciences, Nursing, or related field, with 9+ years experience in clinical development environment

• Exposure to protocol design and execution

• Experience planning and generating Clinical submission documents

• In-depth knowledge of Therapy Area preferred

• Strong written and verbal communication skills, applicable to a regulated environment
  

• Solid understanding of Clinical submission documentation elements, including eCRF/CRF design and data management
  

• Proactive issue identification and risk management skills
  

• Strong collaborative and teambuilding skills
  

• Interpersonal skills (i.e. ability to build relationships with Principal Investigators)
  

• Ability to grasp scientific concepts and translate them

• Benefits
• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance