(Snr) Clinical Development Medical Director, Oncology Solid, 80-100%
Inseriert am: 09.04.2021
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Job ID 316019BR Position Title (Snr) Clinical Development Medical Director, Oncology Solid, 80-100% Apply to Job
Job Description
Over 108,000! That’s how many US patients our oncology products touched in 2018. And while we’re proud of that, 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?
As our Clinical Development Medical Director, you will be the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) Global Program Clinical Head (GPCH) You may lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).
Your responsibilities will include:
• Provide 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 (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
• Lead 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)
• Drive execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
• Coordinate/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
• May be the Program Manager of other associates (e.g., CSE). Support (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
• Support the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities
• As a medical specialist, support the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal partners (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
• May work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L
Minimum requirements
What you'll bring to the role:
• MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area required, with Medical Board Certification preferred
• Fluent oral and written English
• ≥ 5 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 (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• Advanced knowledge of assigned therapeutic area (Oncology Solid)
• Proven ability to establish strong scientific partnership with key stakeholders
• Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
• People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
• Excellent negotiation, conflict resolution and communication skills (written and oral). Strong interpersonal skills
Final title (Clinical Development Medical Director OR Senior Clinical Medical Development Director) and associated responsibilities will be commensurate with the successful candidates’ level of expertise.
Some restrictions to flexible working models may apply and will be discussed at interview if applicable
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: talentnetwork.novartis.com/network Division Global Drug Development Business Unit CD&A GDD Location Switzerland Site Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No
