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Chiesi USA, Inc. · 3 days ago

Sr. Director, Clinical Programs, Global Rare Diseases

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$245K/yr - $400K/yr

4+ years exp

Chiesi USA, Inc. is an international research-focused biopharmaceutical group dedicated to promoting a healthier world. They are seeking a Senior Director of Clinical Programs to ensure effective planning and execution of clinical programs for product approval across various jurisdictions while leading and mentoring the clinical team.

BiotechnologyMedicalPharmaceutical

Responsibilities

Provide effective leadership, oversight, and guidance to team of Clinical Program Leaders, Clinical Research Physicians and Clinical Research Scientists and/or Scientific Medical Writers

Contribute to fostering and developing an environment of high-quality drug development and clinical excellence within GRD R&D

Provide clinical oversight, guidance and support across all relevant studies and programs from study design, conduct through to interpretation and regulatory submissions

Responsible for the development and oversight of robust, well-designed, effective, and innovative Clinical Development Plans

Accountable to ensure that clinical development plans, objectives, and deliverables are consistently accomplished on-time and on-target

Supports in establishing a compelling vision for the relevant assets, assist in the positioning of the medicine within the R&D strategy taking the competitive landscape into account

Serve on the Clinical Development Leadership Team and actively contribute to strategic discussions on the future vision of GRD Clinical Development

Responsible for the assignment of team members to projects, recruitment, and training and/or coaching of new team members

Remain up to date on internal and external developments, trends and other dynamics relevant to the work of Clinical Development

Maintain a fully current view and perspective of internal/external influences and/or implications for the assigned disease area(s)

Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment

Advise on strategic issues for Lifecycle management of assets and post-marketing commitments for assigned products

Communicate with Health Authorities, as and when needed, or otherwise appropriate. Ethically, effectively, and professionally represent the interests of Chiesi and patients

Drive ongoing data generation. Play a lead role within the assigned therapeutic area(s) to identify significant opportunities for unmet medical needs

Participate in ongoing enhancements/development of processes, structures, systems, tools, and other resources

Foster talent management, career development and attracting top talent to Chiesi

Responsible for interface with Research, and to work in collaboration with the Project Leaders to deliver the portfolio and project priorities

May serve as deputy for the Head of Clinical Development for key activities and meetings

Support the provision of high-quality clinical input into evaluation of new opportunities and due diligence projects

Qualification

Clinical DevelopmentClinical Trial DesignLeadershipRare DiseasesMedical Doctor DegreeTeam DevelopmentStrategic PlanningCommunication Skills

Required

4+ years of experience as Global Clinical Leader/Clinical Program Leader is required

Medical Doctor Degree is required

Relevant experience in clinical or academic research in rare diseases or experience in Clinical Development (clinical trial design, conduct and interpretation)

Direct resources management experience is a plus