Senior Director / Executive Director, Clinical Development

PRIMARY FUNCTION

• Lead Physician/head of Clinical Development programs; responsible for establishing and leading a high performing team in the design and execution of Early Phase/Late Phase Clinical Development of assigned assets/investigational agents
• Attract, hire and manage talented clinical research physician(s) or clinical research scientist(s)
• Accountable for driving the clinical development strategy aligned with the regulatory strategy to achieve business goals of product registration in US and other international markets designated key to international expansion
• Ultimate accountability for overall clinical projects’ budget and timelines from proof of concept up to registration; in close collaboration with local Head of Clinical Operations
• As the primary development physician, represent the company while interacting with health authorities, clinical investigators, advisors, CRO’s and other key external stakeholders critical to external engagement excellence
• Accountable for the development of collaborative relationship with key Thought Leaders for the relevant area of our product development
• Accountable for the overall quality and accuracy of all clinical and regulatory documents associated with corresponding clinical projects

MAJOR RESPONSIBILITIES AND DUTIES

• Articulate and implement strategy for identification and relationship management of key opinion leaders/principal investigators
• Recruit highly talented clinical project leader(s) and clinical research physicians able to leverage their experience quickly and independently to drive fast-pace growth of multiple clinical development programs
• Accountable for clinical and regulatory documents; ensure clinical trial design is scientifically sound and regulatory viable
• Ensure high quality and completeness of clinical and regulatory documents, including, but not limited to, clinical study protocol, investigators brochure, clinical study report, summary documents for NDA submission, scientific paper publication, etc. Ensure project timelines and milestones are well defined and executed on time
• Represent clinical development and research within global cross-functional project team(s)
• Supports the global clinical strategy through Clinical Development, in partnership with relevant matrix team members

QUALIFICATIONS

• MD, PhD
• Hematology/Oncology Board Certification is preferred
• Proven expertise in pharmaceutical/biotech industry (>10 years) with adequate knowledge in ICH guidelines, Good Clinical Practice, etc.
• Experience in clinical development and new drug registration, oncology experience a plus
• Basic mastery of statistics applied to clinical research
• Good ability to interpret complex clinical data and experimental results
• Capability to recruit and manage a high performing team of qualitied people
• Manage budget process, meet local and corporate reporting requirements
• Ability to quickly identify and develop an internal network to support expansion efforts in internally
• Ability to communicate in all situations requiring special tact and diplomacy
• Self-motivated and self-disciplined individual with superb problem-solving and leadership skills
• Excellent English (writing and speaking) and excellent mastery of English medical terminology
• Global mindset; experienced in promoting diversity of thought, experience and perspectives that collectively drive execution with excellence
• Collaborative leader able to drive consensus and make independent tough decisions when necessary