Medical Director/Senior Medical Director, Clinical Development

What you will do:

• Direct involvement in trial design of Phase I/II/III targeting rare or orphan diseases.
• Provide on-going support for open-label extension periods and life cycle management of a product.
• Directly supervise and monitor trial conduct as well as work closely with external medical monitor physicians to assure consistency of conduct across trials.
• Work closely with all functions of the organization and external partners to manage trial execution.
• Provide medical input to global regulatory plans and regulatory meetings in partnership with regulatory affairs.
• Provide medical input to global safety leads and at safety meetings in partnership with safety and medical safety and risk management teams.
• Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
• Develop effective relationships with clinical research organizations to ensure successful medical oversight of outsourced studies.
• Provide clinical assessments during disease/target evaluation, prioritization and selection, identifying novel therapeutics opportunities as well as critical study design and execution challenges.
• Support qualifications of pharmacodynamic/disease markers of assessment of efficacy.
• Work closely with the project management representative(s) to track trial status.
• Work closely with study physicians, as well as other project team members/functional areas to ensure regulatory compliance.
• Author and review clinical study reports, manuscripts, regulatory documents and other written material related to clinical study.
• Be responsible for the scientific quality of all clinical work.
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.

What you bring:

• M.D. or equivalent degree
• Board Certification, Board Eligibility or specialist accreditation in internal medicine or pediatrics; specific experience with classical hematologic diseases is desirable.
• 3-10 years in industry (biotech/pharma) specifically within Clinical Development or closely related functions
• Clinical and managerial experience within pharmaceutical trial design and conduct (POC through Phase 3 experience) within the pharmaceutical industry CRO or Academia is required.
• Experience with trials though NDA preferred, but not required
• Excellent interpersonal and public speaking skills are required for this high visibility position.