SR AD / Director, Senior Clinical Program Leader (Remote)

Description The Director, Senior Clinical Program Leader assumes Clinical Development responsibilities supporting late-stage development projects, reporting to the Global Clinical Development Lead for Pulmonary Fibrosis. The Clinical Program Leader has a medical leadership role for a project or a portion of a project in clinical development, usually beginning after Proof of Concept (Phase II). The Clinical Program Leader provides medical/scientific, technical, and managerial directions to the plans, programs and procedures within their project and indication areas to effectively develop new compounds and/or oversee the optimization of the profile of existing compounds. Duties & Responsibilities

• Represents and is responsible for the Therapeutic Area on various workstreams related 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 oversight to the clinical trial program within their respective project and contributes to continuous 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 within Medicine, within 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 within his/her project in collaboration with the Clinical Development Lead, 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).

Requirements

Senior Associate Director Education and Experience Requirements:

• MD (specialist in respective TA)ideallywith clinical pulmonary experience (fellowship training / ILD expertise preferred) and extensive experience across all stages of clinical drug development.

OR

• PhD with three to five (3-5) years of experience in respective TA ideally with clinical pulmonary or other related Therapeutic areas and extensive experience across all stages of clinical drug development.

Director Education and Experience Requirements:

• MD (specialist in respective TA) ideally with clinical pulmonary experience (fellowship training / ILD expertise preferred) and extensive experience across all stages of clinical drug development.

OR PhD with ten-plus (10+) years' experience in Pulmonary or other related Therapeutic Areas and extensive experience across all stages of clinical drug development. Role Requirements:

• 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-priority projects in collaboration with global matrix teams, regional BI counterparts and external partners
• Ability to act with grace and resilience 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

Eligibility Requirements :

• 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.

Compensation

The base salary range for the SR Associate Director position is $220,000 to $350,000 and the base salary range for the Director position is $250,000 to $394,000. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here . Apply tot his job Apply To this Job