Job Description

1 purpose...to reimagine medicine! The Clinical Trial Leader will be accountable for all aspects of assigned Translational Clinical Oncology (TCO) clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT).

YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:

- Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.

- Chip in to the development of clinical sections of regulatory documents like Investigators\' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.

- Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s).

- Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management.

- In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.

- Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators.

- Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and TCO Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems.

- Sit on Early Program Team (EPT) to chip in to program strategy.

- Ensure that program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable.

- Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage collaborations with external vendors in partnership with the CRO Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed

- For TCO trials, function as local trial leader (LTL), supported by the CPA, for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments. As the LTL, be the primary contact for US sites for clinical conduct of the trial.

- CTLs based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China, supported by the CPA.

- May participate in the on-boarding and mentoring of new TCO staff.

- Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned.

Minimum requirements

WHAT YOU\'LL BRING TO THE ROLE:

ESSENTIAL:
- This position will be located at the Cambridge, MA site and will not have the ability to be located remotely.

- Advanced degree or equivalent education/degree in life science/healthcare strongly recommended

- 4 years of technical, operational and managerial experience in planning, implementing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization with a Bachelors Degree OR 3 years with a Masters Degree OR 1.5 years with a PhD / PharmD Degree

- Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process

- Hands-on experience in patient data review, cleaning and analysis recommended

- Good communication, organization and tracking skills

DESIRABLE REQUIREMENTS:
- Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred

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 achieve 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 ACCOMMODATION
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com (mailto:tas.nacomms@novartis.com) call +1 (877) 395-2339 and let us know that nature of your request and your contact information. Please include the job requisition number in your message.

The pay range for this position at commencement of employment is expected to be between $130,400 and $195,600 / 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

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https (https://talentnetwork.novartis.com/network)://talentnetwork.novartis.com/network (https://talentnetwork.novartis.com/network)

Functional Area

Research & Development

Division

Novartis Institutes for BioMedical Research

Business Unit

TCO NIBR

Employment Type

Regular

Shift Work

No

Early Talent

No

Novartis