Medical Director, Clinical Development Nephrology

AstraZeneca • Boston, MA

1d • Hybrid

About The Position

Medical Director, Clinical Development Nephrology The Medical Director, Clinical Development Sciences Nephrology may lead the clinical sub-team or support the clinical sub-team and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings, as assigned by manager. What You Will Do Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs. Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees. Functionally, supervise and develop medical monitors and/or clinical development scientists (CDS), if any and as assigned by the manager. Lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager. Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents Determine appropriate external experts for advisory boards, steering committees, adjudication committees, and/or data monitoring committees, and lead the team in preparation for meetings. Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy. Serve as the Medical input to the Global Development Team/Subteam and the Medical Expert for clinical study team. Conduct medical monitoring activities during periods of vacations, team restructuring, team departures or in other situations, as assigned by manager. Lead the presentation of clinical trial related information/data to senior management, as assigned by manager. Liaise internally with other members of the clinical development team to drive overall program strategy and development plans. Represent Clinical Development at the Global Program Team. Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review. Support business development activities, such as due diligence and research collaborations, as assigned by manager. May serve as the Translational Science lead for one or more programs, as assigned by manager. Working as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, safety, quality, and project management, or others, as assigned by manager.. Lead Pediatric Program Design and Execution, if applicable and as assigned by manager. Be accountable for the overall integrity of the data in the clinical trial.

Requirements

• Physician with MD or foreign equivalent
• 3-5 years of clinical development experience preferably within industry
• 3-5 years minimum experience as a medical monitor for clinical trials required
• Regulatory experience preferred
• Track record of publication in peer reviewed journals, preferably first-authored publications
• Excellent written / oral communication skills
• Attention to detail and ability to think strategically
• Willingness to take on new responsibilities
• Interest and ability to learn about new therapeutic areas
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours
• We would prefer for you to have Clinical specialty certification from US or foreign equivalent

Nice To Haves

• Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.
• 3+ years of industry experience in clinical development is preferred
• Experience for medical responsibilities on a cross-functional team preferred
• Formal training (certificate or graduate degree) in epidemiology, clinical trials, clinical research, biostatistics is strongly preferred
• Broad experience in the principles of clinical trial methodology, statistics, data analysis and interpretation
• Understanding of general (and specific) therapeutic principles
• Experience designing and executing industry-sponsored clinical trials
• Expert in scientific literature searches and weighing of quality peer reviewed data
• Experience authoring study essential documents, Clinical Study Reports, and regulatory documents
• Strong relevant therapeutic area experience
• Ability to clearly communicate to internal and external stakeholders orally and in writing
• Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
• Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget
• Ability to think both strategically and tactically
• Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data

Responsibilities

• Lead or support the clinical subteam and oversee the design and execution of multiple clinical studies or clinical programs.
• Represent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees.
• Functionally, supervise and develop medical monitors and/or clinical development scientists (CDS), if any and as assigned by the manager.
• Lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents, as assigned by manager.
• Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
• Determine appropriate external experts for advisory boards, steering committees, adjudication committees, and/or data monitoring committees, and lead the team in preparation for meetings.
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans, and therapeutic area strategy.
• Serve as the Medical input to the Global Development Team/Subteam and the Medical Expert for clinical study team.
• Conduct medical monitoring activities during periods of vacations, team restructuring, team departures or in other situations, as assigned by manager.
• Lead the presentation of clinical trial related information/data to senior management, as assigned by manager.
• Liaise internally with other members of the clinical development team to drive overall program strategy and development plans.
• Represent Clinical Development at the Global Program Team.
• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Support business development activities, such as due diligence and research collaborations, as assigned by manager.
• May serve as the Translational Science lead for one or more programs, as assigned by manager.
• Working as part of a cross-functional team with colleagues representing biostatistics, data management, clinical pharmacology, commercial, regulatory, safety, quality, and project management, or others, as assigned by manager..
• Lead Pediatric Program Design and Execution, if applicable and as assigned by manager.
• Be accountable for the overall integrity of the data in the clinical trial.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees