Maximizing talent to make a difference

KEY ACCOUNT MANAGER

Reporting to the Regional Sales Director, Key Account Manager will be responsible for the promotion, sales and support of Medexus Pharma products in their assigned geography, while achieving all territory sales goals and maintaining compliance with Medexus Pharma’s policies that govern field sales activities.  Specifically, the KAM will be responsible for launch of treosulfan and will provide on-label product information to key opinion leaders, health care professionals/accounts and institutions.  The KAM will be responsible for establishing and maintaining relationships within the bone marrow transplant therapeutic area.

Qualifications:

• Bachelor’s degree
• A minimum of 3-5 years of pharmaceutical/biopharmaceutical sales experience with proven track record demonstrating top sales performance and achievements.  Hematology/Oncology experience required; Bone Marrow Transplant sales experience preferred.
• Ability to develop relationships with traditional field sales customers (healthcare providers) and hospital/academic institutions within the oncology/hematology – transplant market.
• Must meet institutional requirements for access to all customers.
• Established relationships with the transplant community strongly preferred.
• Proactive, can-do approach; high motivational and persuasion skills.
• Must have the ability to effectively collaborate within a team environment.
• Must have valid driver’s license.
• Must be willing to travel. Overnight travel will be required.

QUALITY ASSURANCE SPECIALIST

The Quality Assurance Specialist will assist with the oversight of all activities occurring at contract manufacturing organizations (CMO) including batch record review, change controls, deviations, CAPAs, process qualifications and risk assessments.  This position will support the Medexus Manufacturing Science and Technology (MSAT),Quality Control and Regulatory teams with data trending, analysis and reporting. They will ensure that manufacturing records are qualified/validated per cGMP and that all QA activities are conducted in accordance with FDA regulatory requirements to ensure ongoing supply of product to meet clinical and commercial demand.

The successful candidate will have a Bachelor’s degree in biology, chemistry, engineering or other science related discipline; a minimum of four years’ experience in quality assurance disciplines such as manufacturing QA, batch record review, investigation writing, validation or equivalent; a working knowledge of cGMPs as related to biologic and drug manufacturing; a strong understanding of quality and compliance principles and regulations governing biologics and pharmaceutical products; ability to work independently and well in team settings; knowledge of MS Office applications; and knowledge of JMP for data trending.

PROJECT MANAGER

The Project Manager will support matrixed, cross-functional teams focused on contract manufacturing/operations, and continuous process improvement for late stage and commercial products. With input from team members, the Project Manager will develop detailed project plans and manage execution by tracking activities, budgets and spend. The Project Manager is a leader, a facilitator, team manager and a coordinator.

Responsibilities include but are not limited to:

• Organize and facilitate project planning, team meetings and project reviews by working closely with team members; including internal and external stakeholders. Create project timelines and Gantt charts to ensure visibility of project tracking . Track budget and invoices.
• Work cross-functionally and track team activities and timelines to ensure that the deliverables and milestones within the project plan are met
• Identify and proactively mitigate risks to timelines. Support data and risk-based decisions throughout project lifecycles. Identify roadblocks, process/Quality risks, identify solutions, and escalate for resolution quickly when necessary

Qualifications include a Bachelor’s degree in a Life Science or Engineering; 5+ years’ experience in Biotech/Pharma including exposure to Biologics manufacturing, 2+ years’ experience in a Project Manager role; working knowledge of FDA, EMA and ICH guidelines as applied to late stage and commercial phase Biologics; flexibility, adaptability and ability to thrive in a fast-paced environment with a penchant for managing multiple projects of varying complexity and timelines simultaneously; expert knowledge of project management tools and MS Office Suite; strong verbal and written communication skills, responsiveness and a high level of attention to detail.

QUALITY CONTROL SPECIALIST

The Quality Control Specialist will assist with oversight for all analytical work occurring at contract organizations including analytical development, in-process analysis, bioassays, and release testing for drug substance and drug product.  They will ensure that analytical methods are developed and qualified/validated per cGMP and that all QC activities are conducted in accordance with global regulatory requirements to ensure ongoing supply of product to meet clinical and commercial demand.  The QC specialist will assist with comparability, stability and method performance trending programs.  This is a remote position.

Responsibilities include but are not limited to:

• Develop, implement and manage an appropriate cGMP Quality Management System for internal and external contract manufacturers/laboratories in collaboration with Quality Assurance.
• Review QC test results supporting product release and stability testing.
• Coordinate with QC management to manage external cGMP laboratories by reviewing and approving documents as required, including Specifications, SOPs, protocols, reports, test methods, change requests, technical transfers, data trending, OOS/OOT investigations and deviations related to clinical and commercial requirements.
• Ensure that critical cGMP release and stability testing is accurate, compliant, and reported to meet timelines.

The successful candidate will have a Bachelor’s degree in a scientific discipline, preferably in biology, biochemistry, biopharmaceutical sciences or other biologic-science related discipline; a minimum of 4 years of progressive cGMP quality, testing, scientific, and/or manufacturing experience in biotechnology or pharmaceuticals including biologics; expertise in chemical, protein, biological and analytical technologies and laboratory operations, including experience on the bench is required (experience with recombinant forms of human factor IX or similar commercial biologics is desired); an understanding of quality and compliance principles and regulations governing pharmaceutical and/or medical food products.  Candidates who are collaborative team players who can work independently in a fast-paced environment are desired.

SENIOR DIRECTOR, HUMAN RESOURCES

The Senior Director, Human Resources will report to the General Manager and will provide HR leadership to support the achievement of business objectives, goals, and company values within Medexus Pharma in the United States.  The Senior Director, Human Resources will work across multiple functions to ensure oversight and strategic delivery of key objectives that connect to business strategy.  The Senior Director, Human Resources will serve as a trusted advisor to the General Manager, Compensation Committee and Functional Leads on HR matters such as Equity, Succession Planning, Executive Compensation, Leadership Development and Company Culture.  Direct reports include the Sr Manager, Human Resources and Human Resources Coordinator, and the position will partner with staff in the development of a world-class HR strategy.

Qualifications:

• A minimum of 10 years progressive HR leadership experience.
• Bachelor’s degree in business or a related field; degree in Human Resources or Organizational Development and/or master’s degree preferred; SHRM-CP, SHRM-SCP, PHR or SPRH certification highly preferred
• Must be a collaborative team player
• Ability to maintain highest level of confidentiality, integrity, and professionalism
• Strong consensus building, conflict resolution and consultative skills
• Demonstrated ability to lead and influence as part of a business team; approachable and an effective communicator with people across all levels in the organization
• Experience managing complex human resources issues in a high growth, fast paced environment

MEDICAL SCIENCE DIRECTOR

• Northeast Region
• Midwest Region
• MidSouth Region
• West Region

The Medical Science Director functions as a highly trained, field-based, scientific expert who engages health care professionals and external experts in a defined region in the exchange of clinical, scientific, and research information on Medexus Pharma’s portfolio of products. He/she is responsible for developing and maintaining professional relationships with key stakeholders within their territory including healthcare professionals, Investigators, Medical Thought Leaders, Advocacy organizations, Payors and Managed Care organizations, research scientists, government employees, etc. These interactions will be conducted in a compliant manner, and in accordance with all local, state, and national regulations and guidelines.  Through scientific exchange, the Medical Science Director will collect key insights on disease states of interest, along with insights on key competitive markets, to share cross-functionally within various Medexus sub-functions.  The Medical Science Director will also serve as a scientific partner and subject matter expert to internal colleagues and stakeholders. This position will report to the Senior Director, Medical Sciences and will require up to 50% travel.

Qualifications:

• Advanced degree in a scientific discipline (MD, PharmD, PhD, etc)
• A minimum of 3-5 years of pharmaceutical industry experience
• 3+ years of field medical experience preferred, particularly in hematology, oncology, or related field
• Product launch experience strongly desired..
• Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.

REGIONAL BUSINESS DIRECTOR

• East Region
• West Region

The Regional Business Director (RBD) will be responsible for leading Key Account Managers within an assigned region to achieve all assigned goals and sales strategies, and to maintain compliance with Medexus Pharma’s policies that govern field sales activity.  This position will report to the Vice President of Sales and will closely collaborate with other functional areas within Medexus Pharma to create an environment for success.

Qualifications

• Bachelors’ degree in business or science, masters’ degree preferred.
• Must have extensive, progressive pharmaceutical sales experience including field sales and/or hospital/academic institution sales, with a minimum of five years of sales management experience, preferably in the oncology/hematology transplant market.
• Be highly strategic, with a comprehensive understanding of all facets of the pharmaceutical commercialization process, with relevant experience in a tightly controlled regulatory environment.
• Solutions oriented – highly creative at identifying new and different ways to solve problems
• Have strong organizational, coaching, planning and implementation skills, with an orientation toward prioritization and meeting multiple deadlines.
• The successful candidate will live in a major city with close proximity to a major airport hub  Extensive travel (up to 80%) will be required.

FIELD REIMBURSEMENT MANAGER

The Field Reimbursement Manager will help resolve oncology hospital and transplant center patient-specific reimbursement, coding, precertification, and appeals issues related to Medexus Pharma products as a HIPAA compliant business associate.  The Field Reimbursement Manager will also educate hospital and transplant center staff on coding, support services and payer coverage/medical policies for Medexus products.  The Field Reimbursement Manager is a critical front-line member of the Medexus organization and will work across multiple internal stakeholders including Sales, Marketing, Market Access, Trade, and Reimbursement Support Hotline to deliver an exceptional customer experience.

The successful candidate will have a Bachelor’s degree, preferably in life science or business; a minimum of 7 years of experience in the pharmaceutical/healthcare industry; 2 years of experience in a reimbursement role supporting hospitals and clinics with medical coding, claims/billing processes and submissions to both private and government insurers for pharmaceutical products that are used inpatient and reimbursed under a DRG or Case Rate; strong interpersonal skills.  Coding certification such as Certified Professional Coder (CPC), Certified Coding Specialist (CCS) or Certified Medical Coder (CMC) is strongly desired.  Candidate must live in close proximity to a major airport hub.  Extensive travel (up to 80%) will be required.