Sr. Clinical Development Medical Director - Military veterans preferred

Title: Sr. Clinical Development Medical Director

Applying for this role is straight forward Scroll down and click on Apply to be considered for this position.
Location: Must be local to King of Prussia, PA
Type: Full time permanent - direct with the sponsor client
Start Date: ASAP

Must have

Extensive Oncology clinical trial experience

Robust Phase III Oncology clinical trial experience

US Board Certified MD

Strong industry background

Sr. Clinical Development Medical Director

SUMMARY/JOB PURPOSE:
In collaboration with the clinical teams, the primary role is to lead and execute early/late-stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Monitors adherence to protocols and determines study completion.
Essential Duties and Responsibilities:

Design, prepare, and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.

Act as medical monitor for company sponsored trials.

Support project teams with therapeutic area specific information.

Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.

Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.

Interact with key opinion leaders and investigators in relevant disease specific area.

Ensure consistency of scientific and development strategies for oncology products in development.

Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.

Supervisory Responsibilities:

None

May on case-by-case basis supervise employees, both directly and indirectly through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:

MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) required with a minimum of 8 years of post-residency experience.

Equivalent combination of education and experience

Experience/The Ideal for Successful Entry into Job:

Drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered

Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.

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

Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).

Knowledge/Skills:

Proven ability to effectively work in a cross-functional/matrix environment

Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

Develops technical and/or business solutions to complex problems.

Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.

Ability to develop and maintain relationships with significant key opinion leaders.

Strong interpersonal, influencing, presentation, and written and verbal communication skills

Strong organizational and time management skills

JOB COMPLEXITY:

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

Works on abstract problems across functional areas of the business

Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.

Regularly interacts with executives and/or major customers.

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