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Director of Clinical Development

Job Title: Director of Clinical Development
Location: United States
Industry:
Reference: 512
Contact Name: Jeff Fisher
Job Published: February 13, 2020 11:13

Job Description

Talent International is partnered with an exciting hematology company in the East Bay looking for a Director of Clinical Development/ Medical Affairs.  

 

 

Primary Responsibilities:

· Lead the Clinical Development function and ensure strategic and focused medical strategies for products in Our clients’ pipeline

· Work closely with the project team leaders and project managers to ensure the creation of clinical and strategic development plans

o    With Regulatory, develop regulatory strategy for products in Our clients’ pipeline

o    Provide strategic and design input for clinical trials and clinical development plans, including knowledge of the current and relevant therapeutic area landscape

· Partner with the Research and Development groups to ensure alignment on product development

· Scientifically and medically contribute to the development of research protocol Phases 1-4, post marketing and surveys (prospective and retrospective).

· Strategically partner with Scientific Affairs to review and release decision regarding investigator initiated trials.

· Scientifically/Medically support marketing activities, Hospital Affairs personnel and other groups.

· Partner closely with the Clinical Operations Team in the conduct and execution of Our clients’ clinical trials

o    Provide clinical and scientific input during development, execution, and completion of clinical trials

o    May serve as a project medical expert as well as Medical Monitor (MM) for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO), MM or directly with study investigators.

· Partner with the VP of Clinical Development & Operations on growing the safety function to ensure oversight of Our clients’ products

o    May review safety data for routine medical data review, trend review, and safety signals from ongoing trials.

o    May review serious adverse event (SAE) reports from clinical trials and, in close collaboration with Our clients’ Product Safety and Regulatory Affairs functions, review causality and develop MedWatch reports (including narratives and analyses of similar events) for reportable SAEs.

· Participate in interpretation of data analyses of clinical trial results and drafting of clinical trial reports.

· May draft and/or provide input/review of clinical documents, e.g. protocols, investigator’s brochures, case report form design.

· Lead preparation of clinical sections of relevant regulatory filings to Health Authorities.

· Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content.

· Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards).

· Develop and manage relationships with key opinion leaders for clinical programs.

Requirements:

· Medical Degree with specialization in hematology/oncology and expertise in hemoglobinopathies preferred

· Minimum of 5 years’ experience in pharmaceutical or biotech industries preferred or equivalent academic and clinical experience

· Experience with clinical trial design, conduct, and medical monitoring, including working with external service provides (e.g., CROs)

· Experienced leading teams and collaborating with cross-functional groups in a matrix environment.

· Trained and experienced in conducting trials according to Good Clinical Practice (GCP) guidelines.

· Excellent written and oral skills, including presentations at conferences and training sessions.

· Collaborative and flexible in personal interactions at all levels of the organization.

· Ability to work proactively and effectively with exceptional creative problem-solving skills.

· Ability to think strategically to move Our clients’ assets forward.

· Up to 25% travelTalent International is partnered with an exciting hematology company in the East Bay looking for a Director of Clinical Development/ Medical Affairs.  

 

 

Primary Responsibilities:

· Lead the Clinical Development function and ensure strategic and focused medical strategies for products in Our clients’ pipeline

· Work closely with the project team leaders and project managers to ensure the creation of clinical and strategic development plans

o With Regulatory, develop regulatory strategy for products in Our clients’ pipeline

    • Provide strategic and design input for clinical trials and clinical development plans, including knowledge of the current and relevant therapeutic area landscape

· Partner with the Research and Development groups to ensure alignment on product development

· Scientifically and medically contribute to the development of research protocol Phases 1-4, post marketing and surveys (prospective and retrospective).

· Strategically partner with Scientific Affairs to review and release decision regarding investigator initiated trials.

· Scientifically/Medically support marketing activities, Hospital Affairs personnel and other groups.

· Partner closely with the Clinical Operations Team in the conduct and execution of Our clients’ clinical trials

    • Provide clinical and scientific input during development, execution, and completion of clinical trials
    • May serve as a project medical expert as well as Medical Monitor (MM) for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO), MM or directly with study investigators.
  • Partner with the VP of Clinical Development & Operations on growing the safety function to ensure oversight of Our clients’ products
    • May review safety data for routine medical data review, trend review, and safety signals from ongoing trials.
    • May review serious adverse event (SAE) reports from clinical trials and, in close collaboration with Our clients’ Product Safety and Regulatory Affairs functions, review causality and develop MedWatch reports (including narratives and analyses of similar events) for reportable SAEs.
  • Participate in interpretation of data analyses of clinical trial results and drafting of clinical trial reports.
  • May draft and/or provide input/review of clinical documents, e.g. protocols, investigator’s brochures, case report form design.
  • Lead preparation of clinical sections of relevant regulatory filings to Health Authorities.
  • Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
  • Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards).
  • Develop and manage relationships with key opinion leaders for clinical programs.

Requirements:

· Medical Degree with specialization in hematology/oncology and expertise in hemoglobinopathies preferred

· Minimum of 5 years’ experience in pharmaceutical or biotech industries preferred or equivalent academic and clinical experience

· Experience with clinical trial design, conduct, and medical monitoring, including working with external service provides (e.g., CROs)

· Experienced leading teams and collaborating with cross-functional groups in a matrix environment.

· Trained and experienced in conducting trials according to Good Clinical Practice (GCP) guidelines.

· Excellent written and oral skills, including presentations at conferences and training sessions.

· Collaborative and flexible in personal interactions at all levels of the organization.

· Ability to work proactively and effectively with exceptional creative problem-solving skills.

· Ability to think strategically to move Our clients’ assets forward.

· Up to 25% travel

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