Assoc Director/Director Clinical Science - Infectious Disease and Vaccines (Remote)
Austin
Texas
United States
Healthcare - Physician
(No Timezone Provided)
About PPD
Job Description
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
About The Position
The Associate Clinical Science Director is responsible for providing input into and, at times, coordinating input for clinical consulting RFPs. The clinical scientist will also support the clinical trial RFP process and partnering with a feasibility and study operations lead through medical and data analysis to summarize the epidemiology, standard of care and competitive environment for the given opportunity.
Current opportunities open in Infectious / Rare Diseases and Hematology / Oncology areas.
About Our Culture, Career Advancement And Benefits
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well-being of our employees.
Job Description
Strong team work skills required to work with a cross-functional consulting team (experts in regulatory strategy, product development, biostatistics and pharmacokinetics). In addition, this role will be involved in projects in partnership with clinical scientists who will provide additional training and guidance. This is considered a subject matter expert level clinical scientist role.
- Developing, designing and optimizing protocol synopses and full protocols
- Creating clinical development plans and gap analyses
- Assisting in coordination of key opinion leader advisory boards
- Conducting feasibility assessments
- Providing competitive intelligence support for the PPD RFP process
- Providing clinical strategy into pre-IND briefing packages
- IND and NDA/BLA submission support
- Other global regulatory submissions as needed
Job Qualification
Education And Experience
Pharm D, Ph.D or MD in a scientific discipline or related field required (clinical training and/or experience strongly preferred).
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3-5+ years of experience working in the biotech/pharmaceutical industry) or equivalent combination of education, training, & experience.
Knowledge, Skills And Abilities
- Familiarity with the conduct of global clinical trials
- Knowledge of GCP/IHC and FDA guidelines
- Excellent interpersonal and communication skills
- Strong attention to detail
- Good organizational, prioritization and time management skills
- Ability to work on multiple projects simultaneously
- General familiarity with biostatistics and pharmacokinetics
- Expert in navigating scientific literature, interpretation of data & display of data
- Ability to work both independently and in a team environment
- Highly proficient in standard computer software (MS Word, Excel, Power Point)
Below Is Listed The Working Environment/requirements For This Role
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Able to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- This role requires independent travel up to 15%, inclusive of traveling in automobiles, airplanes, and trains.
PPD Defining Principles
- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we would love to hear from you.
Assoc Director/Director Clinical Science - Infectious Disease and Vaccines (Remote)
About PPD
Job Description
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!
About The Position
The Associate Clinical Science Director is responsible for providing input into and, at times, coordinating input for clinical consulting RFPs. The clinical scientist will also support the clinical trial RFP process and partnering with a feasibility and study operations lead through medical and data analysis to summarize the epidemiology, standard of care and competitive environment for the given opportunity.
Current opportunities open in Infectious / Rare Diseases and Hematology / Oncology areas.
About Our Culture, Career Advancement And Benefits
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well-being of our employees.
Job Description
Strong team work skills required to work with a cross-functional consulting team (experts in regulatory strategy, product development, biostatistics and pharmacokinetics). In addition, this role will be involved in projects in partnership with clinical scientists who will provide additional training and guidance. This is considered a subject matter expert level clinical scientist role.
- Developing, designing and optimizing protocol synopses and full protocols
- Creating clinical development plans and gap analyses
- Assisting in coordination of key opinion leader advisory boards
- Conducting feasibility assessments
- Providing competitive intelligence support for the PPD RFP process
- Providing clinical strategy into pre-IND briefing packages
- IND and NDA/BLA submission support
- Other global regulatory submissions as needed
Job Qualification
Education And Experience
Pharm D, Ph.D or MD in a scientific discipline or related field required (clinical training and/or experience strongly preferred).
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3-5+ years of experience working in the biotech/pharmaceutical industry) or equivalent combination of education, training, & experience.
Knowledge, Skills And Abilities
- Familiarity with the conduct of global clinical trials
- Knowledge of GCP/IHC and FDA guidelines
- Excellent interpersonal and communication skills
- Strong attention to detail
- Good organizational, prioritization and time management skills
- Ability to work on multiple projects simultaneously
- General familiarity with biostatistics and pharmacokinetics
- Expert in navigating scientific literature, interpretation of data & display of data
- Ability to work both independently and in a team environment
- Highly proficient in standard computer software (MS Word, Excel, Power Point)
Below Is Listed The Working Environment/requirements For This Role
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Able to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- This role requires independent travel up to 15%, inclusive of traveling in automobiles, airplanes, and trains.
PPD Defining Principles
- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we would love to hear from you.