Director, Senior Clinical Program Leader – Rheumatology

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver comprehensive medico-scientific and strategic leadership for clinical programs to expedite clinical development and secure regulatory approvals for reimbursable medicines.

• Maintain ongoing medical benefit and risk oversight for assigned assets.

• Mentor and supervise other Clinical Program Leaders allocated to the program/asset.

• Spearhead the development and implementation of comprehensive evidence generation strategies, integrating contributions from all medical functions as the Evidence Team leader.

• Enhance patient value, incorporate patient feedback, and improve quality of life and outcomes in alignment with Medicine Excellence objectives.

• Formulate and implement clinical development strategies for specific programs as part of an Integrated Asset Evidence Strategy.

• Direct medical strategy and key clinical program deliverables throughout the entire clinical development cycle.

• Chair and unify cross-functional outputs from the Evidence Team across Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance, Regulatory, Medical Affairs, Market Access, Epidemiology, and RWE.

• Take on clinical development and budget responsibilities for designated programs.

• Present proposals and updates to internal governance committees and external entities, including health authorities, advisory boards, steering committees, and medical/patient societies.

• Plan, analyze, and present clinical study data from first-in-human studies through pivotal trials, incorporating regional insights.

• Ensure strategy alignment with operational excellence and perform continuous risk/benefit assessments.

• Author Investigator Brochures, Clinical Development Plans, core clinical trial protocols, pediatric development plans, and sections of regulatory documentation.

• Contribute to regulatory strategy and lead clinical development discussions during regulatory interactions and submissions, including IND, NDA, BLA, and MAA.

• Lead the writing of clinical abstracts, congress presentations, and manuscripts; review and approve project publications.

• Define the medical digital strategy, including tools/vendors, qualification, and validation plans for virtual/digital endpoints.

• Collaborate with the Digital Content Manager on tools, technologies, and best practices.

• Provide insights into Medical Affairs strategy and deliverables, including medical chapters of integrated brand plans.

• Ensure all programs adhere to GCP requirements and global regulatory and ethical standards.

⛳️ Requirements

• MD (specialist in the relevant therapeutic area) with extensive experience across all phases of clinical drug development, OR a PhD with over ten (10+) years of experience in the relevant therapeutic area and extensive experience across all phases of clinical drug development.

• Strong commitment to high ethical standards and a passion for transforming the lives of patients with unmet needs.

• In-depth knowledge of the Medicine strategy and vision, along with a profound understanding of the therapeutic area strategy and vision.

• Ability to assess essential study concepts, including background, sample size, statistical methods, design, timing, feasibility, and budgeting.

• Strong medical and scientific leadership skills to drive complex/high-priority projects in collaboration with global matrix teams.

• Exceptional strategic mindset complemented by excellent communication, influencing, presentation, and training abilities.

• Proven capacity to cultivate internal relationships and exert influence in a matrix and virtual environment, as well as external relationships with thought leaders and industry bodies.

• Established history of interaction with regulatory affairs authorities, international societies, and other relevant stakeholders.

• Advanced management capabilities.

• Agile and effective working style.

• Ability to act as a deputy for more experienced roles.

• Must be legally authorized to work in the United States without restrictions.

• Must be willing to undergo a drug test and post-offer physical examination (if required).

• Must be at least 18 years of age.

🏝️ Benefits

• Eligibility for role-specific discretionary bonuses.

• Relocation assistance.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Opportunities for retirement savings.

• Paid time off.

• Paid holidays.

• Disability insurance.

• Life insurance.

• Additional company-sponsored programs.

• Supportive working environment.

• Opportunity for meaningful work.

• Mobility options.

• Networking opportunities.

• Emphasis on work-life balance.