Manager/Sr. Manager, Clinical Supply Chain
The Manager/Sr. Manager, Clinical Supply Chain position ensures that all clinical trials, including multiple global Phase 3 studies, have timely and adequate supply for administration to patients. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. This role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, return or destruction and global distribution logistics including import and export management. This position will also be responsible for driving the clinical packaging strategy for all materials needed for global clinical studies by working closely with Clinical Operations, CMC and contracted CROs and CMOs to determine manufacturing and supply needs and timelines.
The individual must have the ability to work independently and also act as an effective and engaged team member in a fast-paced environment. Strong initiative, high accountability, natural curiosity and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
- Act as a key interface between the CMC and clinical teams.
- Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time.
- Managing clinical labeling including label design, translation and production.
- Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams.
- Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies
- Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors.
- Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Setting up Interactive Response Technology (IRT) Systems with the clinical team, including UAT testing.
- Monitor regularly drug expiration; initiate inventory release and re-supply with the IRT system, serving as the unblinded inventory manager.
- Write and execute test scripts for supply chain management in the IRT system.
- Achieve operational objectives by providing information and recommendations to trategic plans and Budget reviews
- Support department budget activities.
- Review departmental SOPs and ensure updates and compliance with industrial standards.
- Develop strong internal collaboration with stakeholders, such as Clinical Operations, Regulatory Affairs, Quality, Pharmaceutical Sciences and Manufacturing functions, to ensure high customer satisfaction
- Perform other duties as assigned.
Qualifications and Requirements
- BS or MS degree with 10+ years industry experience in clinical or commercial supply chain management. Title based on experience.
- Proven experience with forecasting, demand / supply planning, inventory management, clinical, packaging, labeling and distribution including cold chain, import/export and reverse logistics.
- Experience with clinical blinding practices.
- Experience in assisting set-up of IRT Systems for global clinical studies.
- Experience in sourcing and managing comparator drugs and other co-meds for clinical studies.
- Experience in CMO and CRO vendor management.
- Working knowledge of drug development process (Phase I-IV).
- Working knowledge of cGMPs and familiar with US and EU regulations
- Strong analytical and problem solving skills.
- Ability to handle multiple projects simultaneously.
- Proven project management skills.
- Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.
- Finance related experience including preparing and supporting department budgeting forecast.
- Strong computer (excel, powerpoint, visio), organizational, and management skills.
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Daily demonstrates a positive, ‘can do’ and solution-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Skilled in developing collaborative internal and external relationships.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint and Visio).
Communication & Interpersonal Skills
- Excellent verbal and written communication skills
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Domestic or international travel may be required per business needs