Note: The job is a remote job and is open to candidates in USA. Merck is a leading pharmaceutical company focused on anti-infective drug development. The Senior Director, Clinical Development will oversee clinical research studies in the infectious diseases therapeutic area, ensuring protocol development and regulatory compliance while collaborating with cross-functional teams.
Responsibilities
- 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
- 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
- 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
Skills
- 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
- 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
- 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
- Background in infectious diseases clinical research and drug development
- Prior experience with registrational trials and filing with major health authorities
Benefits
- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
- Flexible Work Arrangements: Remote
- Relocation: Domestic
- VISA Sponsorship: Yes
- Travel Requirements: 10%
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