Ideal candidate is an action-oriented, customer-focused individual who can effectively work independently or collaborate and communicate with internal and external customers.
Primary responsibility is leading operational excellence, with some supervision, through a matrix-environment with external service providers (“ESP”) utilized by IM US in support of internal customer programs. Drive the standardization and implementation of IM US’ ESP sourcing needs with internal working practices, Novartis Procurement Guidelines and industry best practices. Lead and maintain IM US as a Designated Sourcing Organization (“DSO”) and aligning ESP management globally with internal and external parties. Achieve operational efficiency, quality and compliance across multiple areas of expertise. Must possess a strong knowledge of contract types and terms and procurement and outsourcing principles necessary to lead in-depth conversations and negotiations with third parties and internal stakeholders regarding scope of services and to facilitate timely, complex contract negotiations, rate cards, schedule of payments and research budgets. Ability to navigate through internal Novartis applications and systems and to conduct and manage the third-party management onboarding process with ESPs and healthcare organizations (“HCO”).
Secondary areas of responsibility include budget and contract negotiations and the development of scopes of work which require an advanced knowledge and understanding of Phase II to IV Sponsored Studies, Investigator Initiated Trials (IITs), Managed Access Programs (Compassionate Use and Expanded Access Programs), Non-Integrated Studies, HEOR, Fair Market Value, HCP engagement (inclusive of Consulting and Authorship Agreements), Master Services Agreements, ICF/HIPAA authorizations and simple and complex confidential disclosure agreements. Responsibilities, which may shift based on evolving business needs in an agile, fast-paced working environment. Works under the direction of the Director, Integrated Medical Operations for HEOR and Master Services Agreements.
Your responsibilities:
• Lead and manage complex contract, procurement and outsourcing discussions with internal customers, ESPs and HCOs and be able to effectively explain and negotiate language and Fair Market Value (FMV) for in-scope agreements, rate cards, schedule of payments and research budgets.
• Full ability to work through internal, ESP systems, questionnaires and qualification criteria with oversight from IM US Director.
• Operate as the IM US DSO lead and be responsible for the delivery of quality, timely, and cost-effective solutions for ESPs in adherence with Novartis SOPs, working practices and Global Procurement Guidelines.
• Co-leads key internal local and global alliances and projects to ensure IM US is prepared to successfully respond to the evolving needs and requirements of its internal and external customers and stakeholders, i.e., Legal, Patents, Privacy, Finance and Ethics, Risk and Compliance [“ERC”]).
• Responsible for leading IM US in negotiations of all ESP contract-based negotiations, requests for proposal and bid defenses to adequately support and source IM US’ strategic initiatives.
o Interprets complex project scopes and scenarios to provide creative solutions to Head, IM US IMO and respective leadership teams to support the management of complex business contractual situations and to reduce business risks & exposure.
o Key collaborator with Legal, Patents, Privacy and ERC to lead the resolution contractual issues including indemnification, subject injury, privacy, intellectual property, confidentiality, and compensation within the framework of the US legal and compliance requirements.
Key matrix lead for yearly productivity, documentation, and presentation.
• Supports the identification and integration of novel sourcing platforms.
• Supports patient engagement ESP initiatives.
• Co-Leads in a matrix environment, IM US ESP alliances and internal relationships with Global Procurement and key external partnerships with ESPs to ensure consistency in documentation, quality, and operations for the matrix team.
o Oversight of IM US ESP management consistent with Global Procurement and VPG including acting as the Subject Matter Expert (SME) for the maintenance, management and governance of ESPs.
o Co Leads the oversight and maintenance of in-scope, research collaborations utilizing a risk-based approach for quality assessments.
o Key lead in external meetings with key customers and external partners to promote and ensure efficient operational strategies such as contract-based risk- sharing, joint KPIs/KQIs/KPIs, management of inflation-related budget impact to pricing models, etc.
• Serves as IM US expert advisor for the engagement of external workforces.
• Represents IM US on all Global workstreams with VPG and ERC related to ESPs.
• Represents IM US in internal and external audits and support correction actions (CAPAs), as required with Governance and Director oversight.
• Ensures all vendor contractual relationships and contracts are maintained and prepared in compliance with the applicable legal, regulatory, and financial standards (SOX, ICH, etc.).
• CO Leads and champions the IM US procurement initiatives to drive productivity and embed services into our model to shift appropriate work across IM US, as applicable:
o Track productivity and deliver financial cost savings.
o Drives the success of all deliverables critical to IM US’s strategic plan.
• Develops matrix reports to drive high-performance in accordance Novartis Values & Behaviors.
• Management of IM US IMO’s applicable working practices.
The pay range for this position at commencement of employment is expected to be between: AD: $144,000 – $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 will bring to the role:
• Candidates must possess a minimum of 8 years of pharmaceutical industry experience and 5 years’ experience working with external service providers.
• BS/BA is required. An advanced legal or business degree is preferred or the equivalent on the job, operational experience of 12 years.
• Detailed understanding of and experience with the clinical development process and the management of clinical trials, HEOR (NIS and) and other Medical Affairs activities.
• Ability to work independently.
• Demonstrated ability to be successful in an agile Flexible Resource Model Team with the ability to master secondary skill set to flex to business goals.
• Strong ability in strategic planning, contract and budget management and the negotiation of research budgets.
• Excellent influencing and negotiation skills with internals & externals.
• Deep understanding of contract types and legal terms and conditions).
• Strong knowledge of vendors in different categories including CROs, Central Labs, HEOR, REMS, Publications, etc.
• Solid financial understanding (of cost drivers for research programs, clinical trials and vendor outsourcing models) as it relates to contracts and cost reductions.
• Excellent written and oral communications skills.
• Strong problem-solving skills.
• Strong cross-functional and proven collaboration skills with external and internal stakeholders.
• Ability to think strategically and to visualize potential future scenarios based on business needs.
• Demonstrated willingness to make decisions and to take responsibility for such.
• Ability to address issues assertively while maintaining a professional posture.
• Excellent interpersonal skills and be a team player that works well in an agile team environment.
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 to [email protected] 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.
Customer-facing roles only:
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 [email protected].
Field roles with a dedicated training period only:
The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week
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