Senior Director, Clinical Development - Antibacterials, Antifungals, CMV & Covid 19

Senior Director, Infectious Diseases Clinical Research

Anti-infective drug development has been our core mission for over 80 years. Our Clinical Research group is at the forefront of global healthcare through research and innovation to combat established and emerging pathogens. Through clinical trials we ensure that our existing and pipeline products are developed to produce safe, effective, and innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely access to our medicines.

The Senior Director has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving investigational or marketed drugs in the infectious diseases therapeutic area. The individual will participate in all phases of the clinical trial process (mainly Phase 2-3) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The individual will apply an in-depth understanding of the disease under study and drug pharmacology to the infectious disease therapeutic area's clinical development strategy and the implementation of short- and long-term research objectives.

They will provide internal scientific leadership for cross-functional areas supporting clinical development and external leadership through interaction with key scientific leaders.

Role may be remote

Specifically, the Senior Director may be responsible for:

• Planning clinical trials (design, operational plans) based on the clinical development strategies for investigational or marketed infectious disease drugs
• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed infectious disease drugs
• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
• Participation in internal and joint internal/external research project teams relevant to the development of investigational drugs, and the further study of marketed drugs
• Developing clinical development strategies for investigational or marketed infectious disease drugs
• Presenting study data and program strategic plans to internal governance committees for endorsement and key program milestones

The Senior Director is responsible for maintaining a strong scientific fund of knowledge by:

• Maintaining awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies
• Establishing communications with prominent clinical investigators in their particular field of interest, particularly those scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
• Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.

To accomplish these goals, the Senior Director may:

• Author detailed development documents and presentations for internal and external audiences
• Author scientific publications
• Facilitate collaborations with external researchers around the world
• Travel on company business up to about 10% of the time to manage future or ongoing clinical research projects.

Qualifications

Education:

• M.D or M.D./Ph.D preferably with demonstrated expertise in infectious diseases
• Eligibility for medical licensure and board certification desirable
• An individual with postgraduate program yielding a PharmD degree and demonstrated expertise in clinical practice or clinical research may also be considered for the position

Requirements:

• Industry experience in clinical research and drug development (at least 5 years)
• Demonstrated success in overseeing clinical studies and protocols
• Demonstrated record of scientific scholarship and achievement
• Experience in clinical medicine
• Excellent communication skills, both verbal and written
• Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience

Preferred:

• Background in infectious diseases clinical research and drug development
• Prior experience with registrational trials and filing with major health authorities

Required Skills:

• Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial Compliance, Clinical Trial Development, Clinical Trials, Data Analysis, Decision Making, Drug Development, Ethical Standards, Infectious Disease, Infectious Disease Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Mentorship, Protocol Development, Regulatory Compliance, Regulatory Reporting, Scientific Consulting, Scientific Publications, Strategic Planning, Vaccinology, Veterinary Medicine

Preferred

Skills:

The salary range for this role is $ - $. This is the lowest to highest salary we in good faith believe we would pay for this…