358932BR
Nov 27, 2022
USA

Job Description

Hundreds of millions of people globally are negatively impacted by musculoskeletal diseases (MSD). Among these, neuromuscular disorders like ALS, muscular dystrophies, and peripheral neuropathies cause pain and discomfort, limiting independence and often shortening the lives of patients. Novartis is exploring new frontiers to treat neuromuscular diseases (NMD) and other musculoskeletal disorders.

In the role of Executive Director, MSD NMD you will provide medical and scientific leadership and expertise in a role that significantly impacts the entire Novartis Neuromuscular Disease drug development pipeline.

In this key position you will:

• Drive success of early global programs, develop and implement strategies to achieve clinical Proof of Concept
• Drive success of late global programs when appropriate by developing and implementing strategies that lead to clinical pharmacology, design of mechanistic studies and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling
• Provide scientific expert assessments and support for in-licensing opportunities, including due diligences

Your responsibilities will include but not be limited to:
Translational Medicine early clinical projects:
In collaboration with your Translational Medicine Therapeutic Area Head or other Translational Medicine Experts
• Develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in a single or multiple indications, including Parallel Indication Expansion-Proof of Concepts
- Represent TM and lead global project teams through First in Human and Proof of Concept phase to drive implementation of the Proof of Concept strategy
- Convene relevant internal and external leaders together to consider the proposed approach to Proof of Concept
- In collaboration with research scientists, contribute to the proposal of new targets or indications for existing compounds; identify, develop, and implement strategy for preclinical support of clinical program-related scientific objectives. This includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, and other relevant activities
- Responsible for implementing studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies.
- Responsible for clinical portions of the Integrated Development Plan, including the Clinical Development Plan and Clinical Pharmacology Plan
• Accountable for compound and disease related biomarker strategies, working closely with Biomarker Experts in implementation
• Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures.
• Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study
• Provide medical and scientific leadership and expertise to all line functions on the study team
• Leadership
- Lead study-specific teams/ clinical trial teams
- Represent TM or lead NIBR project teams
- Lead NIBR-sub-teams on Global Project Teams for late-phase programs
- Represent Translational Medicine on global development teams
• Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)
• Represent clinical Translational Medicine in reviews of external opportunities
• Oversee publication and external presentation of study results
• Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches
• Contribute to initiatives that drive innovation, quality, and efficiency across Translational Medicine

Translational Medicine late-stage clinical projects:
In collaboration with your Translational Medicine Therapeutic Area Head:
• Drive analysis of studies and present results to relevant decision boards
• Communicate clinical team matters to Global Project Teams, relevant Novartis Institutes of BioMedical Research and Global Drug Development boards, and other Novartis Boards as required.
• Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders
• Provide support for dose selection, design and other clinical pharmacology matters throughout the development cycle
• Responsible for content and authoring of documents needed for submission documents with Translational Medicine input (CO, SCE, SCS, SCP, SBP) of NDAs, sNDAs, MAAs, BLAs from regulatory submission through drug registration, including advisory committee and scientific advice group meetings

In this role you will have people management responsibility with 1-3 direct reports and matrix people responsibility per project: 5-8 cross-functional members from within Translational Medicine plus other line functions per project team

The ideal location for this role is the Cambridge, MA site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to Cambridge, MA site, as determined necessary by hiring manager. For associates working on-site, relocation assistance to be within 50 miles of the site may be available. This position will require 25% travel as defined by the business (domestic and or international).

The pay range for this position at commencement of employment is expected to be between $270,400 and $405,600/ year; however, while salary ranges are effective from 1/1/22 through 12/31/22, 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.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:
• Medical Degree and additional PhD/post-doctoral equivalent immunology research
• Specialized further training (board certification) and / or clinical research experience in neuromuscular diseases/neurology required
• Advanced / business-level / fluent English (oral and written)
• Recognized for medical expertise: demonstrated excellence and clinical / patient expertise in neuromuscular diseases
• Recognized for scientific expertise: respected by colleagues internally and externally, you’ve made significant contributions to your field and created / established new concepts; record of high quality publications in international scientific journals.
• Previous relevant & significant clinical study experience: either from pharma/biotech leading early phase clinical trials; a senior role within a CRO responsible for leading the medical relationship with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience. You are used to working independently and within teams including scientists and non-scientists on study planning and execution, demonstrating competence in a broad range of project and more strategic planning skills
• Excellent written and oral communication/presentation skills, used to distilling and effectively conveying significant messages to different audiences

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 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.

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://talentnetwork.novartis.com/network
No video provider was found to handle the given URL. See the documentation for more information.
NIBR
Translational Medicine
USA
Cambridge, MA
Research & Development
Full Time
Regular
No
careers default image
358932BR

Executive Director, TM MSD Neuromuscular Diseases

Apply to Job Access Job Account