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Clinical Development Medical Director

myGworkBarcelona Provincial, Spain

Hace 27 días

Tipo de contrato

A tiempo completo

Descripción del trabajo

This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Summary

As our Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data.

About the Role

The Clinical Development Medical Director (CDMD) for Rheumatology is 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.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase)

Your responsibilities include, but are not limited to :

Provide clinical leadership and medical strategic input for deliverables in the assigned project / program. Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents / registration dossiers, and publications (e.g., IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional / country medical associates
Oversee / conduct medical and scientific review of trial data with Clinical Scientific Expert(s). May be the Program Manager of other associates (e.g.., CSE). May function as study medical monitor
Support SR / GPCH in ensuring overall safety of the molecule. May be a core member of the Safety Management Team (SMT), and supports program safety reporting (e.g., PSURs, DSURs, and 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 disease areas.
Provide support to the (Sr.) GPCH or TAH in interactions with external partners (e.g., regulatory authorities, KOLs, data monitoring boards, AD Boards, patient advocacy groups), internal partners (e.g., CTT, Research, Translational Medicine, GMA, Marketing, HE&OR), and decision boards)
Work with NIBR (Novartis Institute of 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 additional matters
Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring support
Contribute to medical / scientific training of relevant Novartis stakeholders on the disease area and compound / molecule. May serve as speaker for franchise.
May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

Minimal Requirements :

MD (or equivalent medical degree) is required.

Medical Board certification preferred. 4+ years Clinical practice experience (including residency) is preferred

Possess advanced knowledge and clinical training in a medical / scientific area (e.g., internal medicine or sub-specialty) is required.

5+ years' experience in clinical research or drug development from the pharma / biotech industry 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

Showcase advanced knowledge of assigned therapeutic area

Demonstrate ability to establish strong scientific partnership with key partners

Need thorough knowledge of GCP, trial design, statistical analysis methodology, and regulatory / clinical development process

Have people management experience preferred, this may include management in a matrix environment. Global people management is preferred.

Exhibit excellent business communication and presentation skills

Possess strong interpersonal skills

Adept with excellent negotiation and conflict resolution skills

Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.

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

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