Clinical Director

4 days ago

King of Prussia, United States Planet Pharma Full time

SUMMARY/JOB PURPOSE:

In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and publications. Supports project teams with scientific information and provides progress updates related to the assigned clinical studies.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

• In collaboration with the clinical study teams for a specific product candidate in clinical development, designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.

• Interacts with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols.

• Researches and assists in the selection of investigators for clinical studies.

• Conducts appropriate literature research for the assigned clinical product candidate.

• Collaborates with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.

• May act as contact of the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.

• Collaborates with clinical operations and other team members in the development of agendas, training materials, and presentation for site visits, investigator meetings, and other study related venues

• Participates in internal safety meetings, analyzes, and reports potential safety events.

• Collaborates with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.

• Contributes to the writing and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.

• Provides feedback on emerging clinical and competitive trends.

• Coordinates and facilitates clinical oncology studies by developing and maintaining excellent working relationships with study investigators.

• Delivers high quality scientific presentations on investigational agents to physicians and other key external customers.

• Provides clinical education support for internal customers.

• Maintains clinical and technical expertise in the therapeutic area of Oncology.

• 10-25% travel requirement.


EDUCATION/EXPERIENCE/SKILLS:

Education:

• Pharm.D., PhD, or M.D. and a minimum of 8 years of related experience; or,

• Equivalent combination of education and experience.


Experience:

• 5-8 years of clinical development experience in the biotechnology or pharmaceutical industry or the equivalent combination of academia and industry.

• Participated in clinical oncology studies with molecular targeted or immunological therapies.


Knowledge/Skills/Abilities:

• Comprehensive and detailed knowledge of clinical trial implementation and drug development process.

• Experience in the design, execution, and reporting of clinical trials in oncology with small and large molecule drug candidates.

• Identifies and implements methods and procedures to achieve results with high quality.

• Performs a variety of complicated tasks with a wide degree of creativity and latitude.

• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.

• May lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.

• Applies strong analytical and business communication skills.

• Highly organized and able to work under tight timelines

• Good public speaking and presentation skills


JOB COMPLEXITY:

• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.

• Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.

• Networks with key contacts outside own area of expertise.

  • Director Clinical Pharmacology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Pharmacology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Pharmacology

    3 weeks ago

    King of Prussia, United States CSL Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Pharmacology

    1 month ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Clinical Science Director Temporary

    4 days ago

    King of Prussia, United States Joulé Full time

    Job Title - Temporary Clinical Science Director Job Location - REMOTE Type: Contract SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical development related documents including...

  • Clinical Science Director Temporary

    5 days ago

    King of Prussia, United States Joulé Full time

    Job Title - Temporary Clinical Science Director Job Location - King of Prussia, Pennsylvania, 19406 Type: Contract SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical...

  • Clinical Science Director Temporary

    5 days ago

    King of Prussia, United States Joulé Full time

    Job Title - Temporary Clinical Science DirectorNot sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. Job Location - King of Prussia, Pennsylvania, 19406 Type: Contract SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the...

  • Clinical Science Director Temporary

    12 hours ago

    King Of Prussia, United States Joulé Full time

    Job Title - Temporary Clinical Science DirectorWant to make an application Make sure your CV is up to date, then read the following job specs carefully before applying. Job Location - REMOTE Type: Contract SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies...

  • Director Clinical Research Hematology

    2 months ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    2 months ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    2 months ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    2 months ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    2 months ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    7 hours ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director Clinical Research Hematology

    5 hours ago

    King of Prussia, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Clinical Director Opportunity

    1 week ago

    King of Prussia, Pennsylvania, United States CW Psychological Services Full time

    Key ResponsibilitiesAs a Clinical Supervisor at CW Psychological Services, your key responsibilities will include:Overseeing clinical hours of licensure and providing administrative training for licensed staffManaging the hiring, onboarding, and orientation of new therapists through training, mentorship, and clinical oversightProviding ongoing training and...

  • Director Clinical Pharmacology

    1 month ago

    King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...

  • Director of Quantitative Evaluation

    1 week ago

    King of Prussia, Pennsylvania, United States Aequor Technologies Full time

    Aequor Technologies is seeking a talented Director of Quantitative Evaluation to develop and implement statistical strategies for clinical trials and regulatory submissions. This role requires excellent analytical and problem-solving skills, as well as the ability to work effectively with cross-functional teams.">Responsibilities:Design and implement...

  • Associate Medical Coding Director

    13 hours ago

    King Of Prussia, United States Joulé Full time

    Title: Associate Medical Coding DirectorConsidering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out. Full Time Permanent Opportunity - Direct with the client Onsite King Of Prussia, PA SUMMARY/JOB PURPOSE: The Associate Medical Coding Director is responsible for the delivery of timely and...

  • Associate Medical Coding Director

    1 day ago

    King of Prussia, United States Joulé Full time

    Title: Associate Medical Coding DirectorConsidering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out. Full Time Permanent Opportunity - Direct with the client Onsite King Of Prussia, PA SUMMARY/JOB PURPOSE: The Associate Medical Coding Director is responsible for the delivery of timely and...