Study Start Up Associate Jobs in Newark, NJ (NOW HIRING)

The Senior Manager, Clinical Drug Supply & Logistics is responsible for providing oversight of individual or multiple clinical programs, forecasting Investigational Product (IP) supply requirements for multiple clinical trials, and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Regeneron SOPs / WPDs. Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability).

• Location: Armonk, NY / Warren, NJ / Cambridge, MA
• Work model/flexibility: in office 3-4 days per week

Supply Planning

• Serves as lead drug supply manager of a program and/or individual studies for the functional area in supply planning, including demand forecasting according to IOPS requirements.

• Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan.

• Works with clinical drug supply management to determine resourcing needs.

• Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals.

• Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines.

Inventory tracking

• Manages and oversees investigational product (IP) inventory strategy; advises supply management team of potential shortages and defines resupply activities based on usage trends and projections.

Shipments

• Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.

IVRS

• Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS.

• Works with cross-functional teams to develop specifications and support user testing of IRT systems provided by 3rd party vendors.

• Leads effort for clinical supply management functionality.

• Monitors and manages clinical supply activities through IRT from study start-up through study closure.

Returns & Destruction

• Develops strategy and oversees drug return and destruction activities.

Expiry Management

• Develops resupply strategies based on stability and shelf-life of clinical supplies.

• Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry.

Ancillary & Comparator Supplies

• Coordinates with other functional areas, including Regulatory, Medical Director, Forecasting & Planning, and IOPS to define ancillary and/or comparator supply strategy.

• Develops plans for supplying clinical study sites with ancillary and/or comparator supplies, either through in-house initiated supply or working with supply vendors.

Documentation

• Provides input to drug kit randomization specifications and reviews and approves master kit lists.

• Designs, reviews, and approves IP-related study tools (for clinical study teams and investigative site use), as needed.

• Supports inspection team in preparation for and during regulatory agency inspection. May represent Clinical Drug Supply & Logistics during regulatory agency inspections.

Study Team Interaction

• Represents Clinical Drug Supply & Logistics on cross-functional study team (s) and/or sub-team(s).

• Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues.

Budget Management

• Provides input into budgets, SoWs, contracts and timelines for IP-related services.

• Creates RFPs, reviews quotes, and awards third-party vendors for distribution services.

• Responsible for distribution vendor budget management (invoice review/approval, change orders, reconciliation); reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated.

Vendor Management

• Leads management of IP service vendors (performance, quality, timelines, deliverables, costs)

• Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS)

• Provides input, reviews, and approves vendor study specifications for IP-related activities.

• Serves as point of escalation for vendor-related IP issues as they arise.

• May require 25% travel

Staff Management

• May supervise staff.

• May mentor or coach junior Clinical Drug Supply & Logistics staff.

Process Initiatives

• Develops and implements process initiatives in accordance with business needs.

Metrics

• Tracks metrics related to drug supply processes and staff.

Training

• Provides assistance in training and development as needed.

Reporting

• Compiles and reports supply status to study teams and senior management

Problem solving

• Applies knowledge of company policies and standard practices to resolve problems.

• A minimum of Bachelors' degree and 8 years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years minimum in clinical supply management.

• Masters/MBA/PharmD with 5+ years of relevant industry experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)