[Remote] SR AD / Director, Senior Clinical Program Leader - Pulmonary Fibrosis (Remote)

Note: The job is a remote job and is open to candidates in USA. reputed company is a global biopharmaceutical company focused on improving lives through innovative healthcare solutions. They are seeking a Director, Senior Clinical Program Leader to reputed company clinical development responsibilities for late-stage projects in Pulmonary Fibrosis, providing medical leadership and direction for trial designs and regulatory submissions.

Responsibilities

• Represents and is responsible for the Therapeutic Area on various workstreams reputed company to the asset(s) being developed, including but not limited to development of trial design outline (TDO) and clinical trial protocol (CTP), pediatric investigational plan development, input into project analysis, results communication, etc. Additional work packages may include medical/scientific contributions to the Investigator Brochure, Company Core Data sheet, Annual Safety Report / IND Safety Reports, as well as preparation for the Milestones Release of Full Development and Release of Submission
• Provides medical reputed company to the clinical trial program reputed company their respective project and contributes to reputed company benefit-risk assessment
• Provides medical leadership in regulatory meetings and contributes to submission strategy, regulatory dossiers, and regulatory authority interactions
• Oversees medical project budgets for the respective project(s)
• Serves as the representative of the development team to leadership committees reputed company Medicine, reputed company the TA (Business Unit Portfolio Committee (BUPC)), and to Corporate Leadership (One Human Pharma Executive Committee (OneHP EC)
• Oversees and supports contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards
• Reviews and approves scientific abstracts and publications reputed company his/her project in collaboration with the Clinical Development reputed company, Head of Medicine (HOM) or Head of Clinical Development, Inflammation
• Identifies and provides input to Medical Affairs evidence gaps, strategy documents, publications, and Product Maintenance and Optimization (PMO)

Skills

• MD (specialist in respective TA) ideally with clinical pulmonary experience (fellowship training / ILD expertise preferred) and extensive experience across reputed company stages of clinical drug development
• PhD with three to five (3-5) years of experience in respective TA ideally with clinical pulmonary or other reputed company Therapeutic areas and extensive experience across reputed company stages of clinical drug development
• MD (specialist in respective TA) ideally with clinical pulmonary experience (fellowship training / ILD expertise preferred) and extensive experience across reputed company stages of clinical drug development
• PhD with ten-plus (10+) years' experience in Pulmonary or other reputed company Therapeutic Areas and extensive experience across reputed company stages of clinical drug development
• Ability to thoroughly evaluate key study concepts including background, sample size, statistics, design, timing, feasibility and budgeting
• Successful track record in planning, conducting, and publishing of Basic Science and/or Clinical Research
• Sound medical and scientific leadership to drive high-reputed company projects in collaboration with global matrix teams, regional BI counterparts and external partners
• Ability to act with grace and reputed company under pressure
• Good project management skills
• Previous interactions with regulatory authorities, and participation in international societies and other relevant international stakeholders
• Good communication and presentation skills
• Excellent cross-functional collaboration skills and ability to work in virtual teams
• Must be legally authorized to work in the United States without restriction
• Must be willing to take a drug test and post-offer physical (if required)
• Must be 18 years of age or older

Benefits

• The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements.
• Our competitive compensation and benefit programs reflect reputed company's high regard for our employees.
• We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.
• Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we reputed company major investments to drive global accessibility to healthcare.

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