Clinical Development Director (Neuroscience)

Novartis; Basel; Hybrid; CHF 120’000 - 160’000; Vollzeit

Zusammenfassung

A global pharmaceutical leader in Basel is seeking a Clinical Development Director with extensive experience in clinical research. This role entails leading the clinical development strategy and ensuring the successful delivery of all assigned clinical deliverables. Candidates should possess an advanced degree in life sciences and a robust background in Neuroscience. The position offers a hybrid working model and a commitment to professional development and inclusion.

Leistungen

Professional development opportunities

Health benefits

Diversity and inclusion initiatives

Qualifikationen

• Background in Neuroscience or related fields required.
• ≥ 7 years in clinical research or drug development.
• People management experience preferred.

Aufgaben

• Lead delivery of clinical deliverables in clinical programs.
• Oversee clinical data review and ensure data quality.
• Ensure inspection readiness for regulatory agencies.

Kenntnisse

Fluent oral and written English

Excellent communication and interpersonal skills

Problem-solving and negotiation skills

Ausbildung

Advanced degree in life sciences/healthcare

Jobbeschreibung

Overview

Clinical Development Director (Neuroscience) role at Novartis. Location: London, Dublin or Basel. Role type: Hybrid working. The Clinical Development Director (CDD) is the clinical/scientific and clinical development expert who provides leadership and support to clinical development deliverables and activities within a defined global clinical development program and/or global clinical trial (e.g., clinical development plan, clinical trial protocol), under the leadership of the GPCH.

Responsibilities

• Supports and, if assigned, leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review and program-specific standards, clinical components of regulatory documents/registration dossiers, and publications.
• Provides input into final analyses and interpretation, including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations.
• Leads 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).
• Oversees/conducts ongoing clinical and scientific review of clinical trial data with medical monitor and Clinical Scientific Expert(s) with appropriate oversight from Medical Lead; works closely with data management and statistics teams to ensure data quality and proper analysis of clinical trial results.
• Ensures inspection readiness and interaction with QA — risk assessments, audit preparation, mock interviews, storyboard and presentation prep; author and/or review abstracts, presentations and manuscripts for accuracy of clinical data and content.
• May be the Program Manager of other associates (e.g., CSE).
• Provides support to Sr CDMD and/or GPCH in monitoring and safety data and signals for the assigned section of the clinical trial; may be a member of the Safety Management Team (SMT) and supports overall program safety reporting (e.g., PSURs, DSURs) in collaboration with the medical monitor, CDMD and Patient Safety.
• As a clinical development expert, may support the GPCH or CDH in interactions with external stakeholders (regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups) and internal stakeholders (CTT, Translational Medicine, Global Medical Affairs, Marketing, HEOR) and internal decision boards.
• May work with Biomedical Research/Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences, together with other medical matters, as assigned.
• Ensures career development of program reports and other clinical colleagues through active participation in performance management and talent planning processes; provides onboarding, training, and mentoring support.
• Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule; may serve as speaker for franchise medical/scientific training.
• May serve on or lead global initiatives (e.g., process improvements, training, SOP development, and other Clinical Development line function initiatives).
• May be assigned to lead clinical trial(s) as Clinical Scientific Lead and provide leadership and guidance for all clinical aspects of a trial in close collaboration with the assigned medical monitor and/or CDMD.

Qualifications

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD or PhD strongly preferred.
• Background or experience in Neuroscience, Neurodegeneration, Neuromuscular, Gene Therapy, Rare diseases, Neuroinflammation or similar required.
• Languages: Fluent oral and written English.

Experience

• ≥ 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (planning, executing, reporting and publishing) in a global/matrix pharmaceutical environment.
• Advanced knowledge of the assigned therapeutic area.
• Demonstrated ability to establish strong scientific partnership with key stakeholders.
• Thorough knowledge of GCP, clinical trial design and methodology, statistical analysis methodology, and regulatory/clinical development process.
• ≥1 year of People management experience; global people management experience desirable.
• Excellent communication skills, written and oral; excellent interpersonal skills; excellent negotiation and conflict resolution skills.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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

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

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Seniority level

• Director

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing