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Medical Director

Duties and Responsibilities Include But Are Not Limited To:
• Provides strategic input into clinical development plan(s) and leverage cross-functional expertise, as required
• Assists with protocol design and synopsis development
• Assists with the development and drafting of regulatory and study documents
• Responsible for study conduct in conjunction with Clinical Operations, including in trial initiation, patient recruitment, and study close-out activities
• Performs study level and program data review
• Provide medical expertise to the study team during key study activities
• Oversees and conducts protocol training; produces relevant training materials
• Participates and/or leads, as appropriate, Pharmacovigilance activities, including safety evaluation for approved and investigational products
• Interacts with regulatory groups and internal auditing groups on a study level
• Contributes to the development and finalization of Clinical Study Reports (CSR), Investigator’s Brochures, and IND Annual Report updates
• Present study data internally and externally
• Develops or assists in development of scientific meeting abstracts and presentations as well as manuscripts
• Organize and lead advisory boards, data safety monitoring boards, and consultations with key opinion leaders
• Participates as a key member of the (s)NDA submission team
• As needed, manages vendors (such as Pharmacovigilance vendor) and manage consultants (such as Pharmacology, Clinical Pharmacokinetic experts, etc.)
• Supports business development activities and interactions with corporate partners
• Establish strong partnerships with KOLs and other healthcare stakeholders
• Participates in cross-functional teams for the evaluation of new development ideas, clinical development strategies and business development assessments.
• Provide leadership on disease state training internally and externally
• Provides cross-functional leadership support and mentoring in a matrixed organization
• Manages direct reports as appropriate.
• Performs other duties as required

Desired Knowledge and Abilities:
• Excellent communication skills; team member that can work collaboratively with colleagues across all functions and at all levels
• Excellent analytical, presentation, writing, and computer skills are required
• Strong scientific background and translation knowledge is an asset
• Ability to maintain a problem-solving attitude in response to time demands and unexpected events
• Demonstrated track record as a solid, thoughtful leader with exceptional interpersonal skills
• Working knowledge of FDA and global processes
• Well versed in GCP requirements.
• Provide administrative leadership and knowledge-based expertise in related areas that can be applied to meeting the strategic goals
• Ability to work well in a deadline-driven environment
• Drives for results
• Ability to work in a cross-functional team
• Capable of supporting multiple projects simultaneously
• Travel as needed

Minimum requirements
• MD or DO with board eligibility or accreditation, preferably in Medical Oncology or Internal Medicine and other related subspecialties
• Experience in designing and executing clinical studies (phase 2-3 at a minimum)
• Minimum of 3 years of experience beyond fellowship training, preferably in the biotech/pharmaceutical industry
• Demonstrated record of scientific/medical publication
• Thorough understanding of oncology drug development and approval processes

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