Associate Director, Cell Therapy Operations Manager-Northeast - Remote

Novartis • Full-time • United States, New Jersey (NJ), East Hanover • $0 / hour • 1w ago

Every year, ~3,500 children are diagnosed with Acute Lymphoblastic Leukemia and ~25,000 adults are diagnosed with Diffuse Large B-Cell Lymphoma. 10% of these children, and 50% of these adults who do not respond to upfront therapies are faced with limited treatment options and low survival rates. Over the past few years, Cell & Gene therapies for these diseases have come to market, bringing new hope to patients, caregivers and HCP's alike. There is still a large unmet need, and at Novartis we are reimagining medicine to continue to bring this innovative therapy to not only these patients, but those with other B-cell malignancies as well.

As an Associate Director, Cell Therapy Operations Manager, you will develop, coordinate and support implementation of the plan to train and qualify apheresis and treatment centers to be able to treat patients with Novartis Oncology Cell Therapy products both in commercial and clinical trial setting. In this role, you will manage CAR-T center operations supporting qualified key staff including HCPs, infusion nurses, study nurses as well as apheresis unit and cell laboratory staff, ensuring that the centers are operating to safely and efficiently treat patients with our products and supporting continuous operations improvements.

Your responsibilities will include, but are not limited to:
• Partner and implement a One Team approach with commercial onboarding teams, including Strategic Account Managers, Kymriah CARES and Apheresis Quality to support implementation of site onboarding as a supplier and end-user of commercial manufactured product.
• Coordinate and guide a One Team approach with internal and external partners in clinical trial support across teams to include Novartis Medical, Novartis Trial Management, Clinical Customer Support, Apheresis Quality and assigned site Clinical Research Associates to ensure successful clinical trial site participation.
• Provide highly engaged site operations support to approved external site staff with a focus on providing guidance as well as continued training based upon approved Novartis messaging through customer facing with ordering physicians, clinical trial Primary Investigators, BMT coordinators, pharmacy, Infusion Nursing Teams, Clinical Trial Coordinators, as well as apheresis units and cell laboratory staff.
• Conduct investigations in partnership with Apheresis Quality within the Novartis quality platform through assigned deviations related to incoming specifications, chain of identity breaches, and other related deviations of Novartis manufacturing specification as well as investigating manufacturing results when requested. Oversee the end-to-end process of deviations in close coordination with all relevant functions to ensure closure of deviation within the due date assigned to each deviation.
• Support the efficient and effective qualification of key treatment and apheresis sites across North America to be in full compliance with Novartis policies and procedures
• Develop and maintain knowledge of the customer, key dynamics, and company policies as well as up to date knowledge of key competitors and their strategies
• Develop and support implementation of new operational service offerings to improve the customer experience (e.g., educational programs, process solutions)

This position can be based remotely anywhere in the assigned Northeast territory which includes the New York City Metropolitan Area, New Jersey, and Eastern PA including Philadelphia (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 60% travel.

The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.What you'll bring to the role:

Education: University degree in science and/or Medical or Business (Bachelor's Degree Minimum)

Required Experience:
• Minimum of 7 years external partner (supplier, customer, contractor) facing role experience and/or leadership experience in healthcare
• Experience in at least one of the following areas:
1) interacting/supporting external partners (e.g., clinical site coordinator, external supplier relations, key account manager)
2) Hospital stakeholder management role
3) Working in a pharmaceutical or hospital GxP environment (e.g., Medical, clinical, manufacturing, hospital, cell processing, or apheresis)
• Comfort with navigating interactions with various subject matter experts across medical and administrative personnel at all levels and in large numbers (15-20 partners/customers per site)
• Demonstrated business insight and interest in skill development
•In-depth knowledge of healthcare industry, agility to learn various disease states and continue to broaden understanding of treatment & payer landscape
• Collaborative approach to engage with local cross-functional team and regional service teams
• Able to operate in ambiguity; adapt to change while developing innovative solutions through strong problem-solving skills and self-awareness to escalate when needed
• Ability to travel up to 60% within North America dependent on site needs
• Flexibility to work outside regular business hours to attend meetings and conferences as well as for site support

Preferred:
• Direct experience/knowledge related to apheresis, blood or tissue collection, or cryopreservation operations

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail totas.nacomms@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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While Novartis does not require vaccination for Covid-19 or proof of a recent negative test result for Covid-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.