Sr Clinical Development Medical Director

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 3 months ago

60! With a 60-year history in neuroscience, Novartis has brought innovative therapies to patients with e.g. Multiple Sclerosis, Alzheimer's disease, Parkinson's Disease, Epilepsy, Depression and Migraine. We have a world-class pipeline in neurodegeneration, neuro-inflammation, neuromuscular and psychiatric diseases. Our holistic R&D approach includes cutting edge molecules, innovative approaches to technology, biomarker and digital therapeutics to seek better solutions for patients.

As a Senior Clinical Development Medical Director, Neurology, you will join a dynamic team who are dedicated to developing treatments to slow the progression of degenerative orphan diseases including Huntington's disease and Spinal Muscular Atrophy.

Your role will be to lead and provide medical strategic input for clinical deliverables or clinical sections of such deliverables (e.g. study protocols, pediatric plan, clinical data review, safety updates, health authority responses, investigator brochures, submission dossiers, briefing books, etc.) for a program in early stage clinical development in Huntington's disease and a more advanced program in spinal muscular atrophy.

Your responsibilities will include:

  • Providing clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications

  • Leading development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)

  • Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates if applicable

  • Supporting (Sr.) Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, acting as a core member of the Safety Management Team, and supporting overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports, and other safety related documents), in collaboration with Patient Safety

  • Supporting the Therapeutic Area Head (TAH) by providing medical input into Integrated Development Plans and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other responsibilities as directed by the TAH

  • As a medical expert, supporting the (Sr.) Global Program Clinical Head or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., Clinical Trial Team, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards

  • MD or equivalent medical degree required. Advanced knowledge and clinical training in neurology required, with Medical Board certification

  • Experience >7 years in late or early drug development for psychiatry and/or neurology, orphan indication or neurodegenerative disease experience preferred

  • Demonstrated ability to establish strong scientific partnership with key stakeholders

  • Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process

  • Demonstrated experience in data presentation and strong negotiation and diplomatic skills, experience with health authorities required

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director (Ad) MS Portfolio Market Development

Novartis Pharmaceuticals

Posted 2 days ago

VIEW JOBS 11/12/2019 12:00:00 AM 2020-02-10T00:00 400,000 patients are diagnosed with Multiple Sclerosis (MS) in the United States. We put patients first, with the hope of improving people's lives, this is a passion for some – is it for you? The Neuroscience Franchise has a rich history and promising future in Multiple Sclerosis, with a multiple product portfolio. We are looking for a highly engaged individual who will play an important role in helping improve the lives of patients with MS. Do you want to be part of a team that puts patients first and puts a strong focus on customer-centric initiatives? Do you want the opportunity to lead and collaborate with cross-functional stakeholders? At Novartis, we are re-imagining medicine to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Your responsibilities will include, but are not limited to: * Support Brand Planning efforts across the franchise to create alignment and consistency at the franchise level * Coordinate portfolio approach for ad-boards, congresses, speaker bureaus, and medical engagement * Integrate marketing strategies and tactical execution to maintain one Novartis Voice * Lead and/or support the development of Peer-to-Peer marketing content for MS pipeline brand and ensure that a robust execution plan is developed and executed for all MS marketed medications * Lead Competitive Intelligence and readiness for all MS portfolio brands * Shape brand strategy, priorities, and activities for one or more segments or channels; drive and measure brand performance; and effectively drive customer engagement across multiple stakeholders that are core to brand success * Partner with (Senior) Product Manager and Director of Marketing, as well as Commercial Acceleration, to generate meaningful insights that are foundational for brand strategy * Maintain effective internal communications to ensure relevant company functions are informed of marketing objectives and key initiatives * Effectively interact with internal customer groups (e.g. Sales force, TLLs) to understand needs and handle requests as needed; aid in the development of field-facing updates and communications * Develop and sustain strong working relationships with other brand marketers and key stakeholders to en-sure alignment and message consistency across customers and channels What you'll bring to the role: * Education: Bachelor's Degree in business and/or biological science education with concentration in marketing are preferred (MBA a plus) * Experience in pharmaceuticals, biotech and/or healthcare required * 5+ years of experience that translate to breadth and depth of marketing-relevant competencies (e.g., marketing, market access, sales leadership, etc.) with fluency across pharma marketing domains * Experience across different US healthcare marketing channels/responsibilities, therapeutic areas, and/or life-cycle stages * Diverse experience outside of marketing (e.g. Customer-facing/sales experience, managed markets, operations, medical, etc.) * Demonstrated experience establishing and engaging key customer groups and other important stakeholders internally and externally to gain deep insights to evolve brand strategy and communication * Track record of success showing strong strategic thinking, problem-solving, and decision-making capabilities * ~25% travel What you'll receive: Competitive salary, annual bonus, long term incentive for select levels, health insurance, paid vacation/holidays, flexible working arrangements, subsidized dining facilities, employee recognition program. Why consider Novartis? 750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges. We are Novartis. Join us and help us re-imagine medicine. Novartis Pharmaceuticals East Hanover NJ

Sr Clinical Development Medical Director

Novartis Pharmaceuticals