Responsible for the clinical and administrative leadership of the Asia Pacific Oncology Clinical Research Leads / Project Leads within the therapeutic domain. Works closely with the Leadership of Oncology Division: Discovery, Preclinical, Regulatory Affairs/Quality, Pharmacovigilance, Medical and Marketing as well as other key R&D departments to provide direction for all clinical research activities within the therapeutic domain. Within Asia Pacific R&D portfolio, the incumbent directs, develops and implements clinical development plans with effective budget planning and ensure coordination with other functions.
Directly lead a group of 3-7 Clinical Research Leads/Project Leads for Oncology theraputics area.
Major interface with the Leadership of DM Division, Discovery, Preclinical, Regulatory Affairs/Quality, Medical and Marketing as well as other key R&D functional departments. External relationships with all the networks within the therapeutic domain, e.g. PMDA, sFDA, Advisory Boards, etc.
Responsible for overall strategy and tactics of clinical development in the therapeutic domain. Alignment of therapeutic domain with other therapeutic areas as appropriate.
Advise the company on creative objectives and overall strategy of development for new compounds within the Oncology therapeutic domain. Manage al team of physicians/clinical leads (Clinical Research Leads/Project Leads) based in multiple R&D sites in Asia Pacific. Act as or appoint a China Champion/Japan Lead to facilitate China/Japan development full participation in global development projects in Oncology. Ensure full consideration of AP for early studies in development Provide scientific/medical leadership to the team of Clinical Research Leads/Project Leads in the designing of regional Clinical Development plans aiming at the most effective and timely clinical development tactics to facilitate the achievement of the strategic goals for registration. Work closely with the Leadership of Oncology Division: Discovery, Preclinical, Regulatory Affairs/Quality, Pharmacovigilance, Medical and Marketing as well as other key R&D functional departments to provide direction for all clinical research activities within the therapeutic domain. Approve clinical documents including investigator's brochures, study protocols and study reports. Represent Asia Pacific R&D during interactions with regional Health Authorities on clinical projects. Coordinate and facilitate regional meetings to review the status of all clinical projects in the therapeutic domain. Ensure compliance with budget and time constraints of all projects with the therapeutic domain. Work with global project teams to develop and implement clinical development plans with effective budget planning and ensure coordination with other functions. Key challenges: Develop and register new products with regional strategy simutaneously with US/EU. Allocate resources for all projects on a regional basis. Work with key thought leaders and regulatory authorities to ensure innovation reach the region in the same time fame as US/EU registration.
JOB-HOLDER ENTRY REQUIREMENTS:
A combination of the completion of an advanced degree, e.g. MD, PhD
Certification in relevant specialties (eg. … Allergy and Clinical Immunology, Rheumatology, Respiratory etc …) is a strong plus.
Experience & knowledge:
- 10+ years of experience in Clinical Drug Development for a large pharmaceutical or biopharmaceutical company including 5+ years experience in leadership role.
- This position requires an individual with a strong medical background particularly in one or a few areas as well as a very good understanding of the drug development process and the regulatory framework for clinical trials.
- Experience in leading multiple, diverse clinical development programs. Management experience in groups, divisions, or departments in a pharmaceutical or sizeable biopharmaceutical company as well as extensive CRO oversight experience.
- The ability to interpret clinical data accurately is essential.
- Strong verbal and written communication skills are required to complement the ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions.
- Good knowledge and experience with the process of data collection, management, and analysis are required for direct and indirect management of this process.
- Cross-cultural and regional experience in Clinical Drug Development
- Ability to run multiple projects on regional basis.
- Sanofi LEAD competency model applies
- Act For Change: Embrace change and innovation and initiate new and improved ways of working
- Strive for Results: Seek ongoing improvement of performance quality to create sustainable added value
- Cooperate Transversally: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results
- Commit to Customers: Understand, meet and exceed internal and external customer expectations to create positive impact
- Develop People: Take responsibility for developing one’s self and others in anticipation of future business needs
- Lead Teams: Build, manage, motivate and empower teams and workgroups
- Think Strategically: Think and plan broadly and long term to inspire excellence in execution
- Make Decisions: Make timely decisions based on the information available
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.