Quality Recruiting. Established Experts.
Senior Director, Oncology Clinical Development
Reference Number: 2743
Location: MA
Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Senior Director, Oncology Clinical Development
The Senior Director, Oncology Clinical Development will have hands-on responsibility designing clinical trials focused on assigned therapeutic areas and will exhibit a passion for Phases 1 through 3, including biomarkers, proof-of-concept and full development.
Major tasks and responsibilities will include:
- Designs and optimizes clinical trial design and ensure clinical trials meet ethical and regulatory standards.
- Leads the Clinical Protocol Team, including interactions with regulatory, research, safety, marketing and other functions.
- Writes protocols that are in-line with the overall indication strategy.
- Must be present at Investigators’ meetings.
- Conducts medical review and interpretation of efficacy and safety data from clinical trials.
- Responsibility for the quality, coordination, medical accuracy and timeliness of clinical study reports.
- Works with other team members to prepare abstracts, manuscripts and presentations for external meetings as well as authors clinical sections of regulatory documents (IB, IND sections).
- Assists senior management to oversee quality, coordination and timeliness of clinical sections of IND’s, Investigator Brochures, CTA’s, ISS’s, ISE’s, and clinical expert reports.
- Presents and discusses data and findings at relevant team, KOL and regulatory meetings.
- Establishes and maintains working relationships with Study investigators, key opinion leaders, and academics.
- Ensures adherence to GCP/ICH and Standard Operating Procedure (SOP) standards.
- Maintains clinical and scientific awareness in area of expertise.
- Ensures Clinical Research consultants are kept fully informed of programs and coordinate their involvement in company activities.
- Provides clinical evaluation of in-license opportunities and/or manages Clinical Research consultants to provide same.
We seek candidates with the following qualifications:
- Minimum M.D. degree and substantial medical/clinical training in hematology/oncology.
- Minimum 5 years of experience designing, leading and managing significant clinical trials.
- Direct industry experience is preferred; substantial experience working on industry-sponsored trials will be considered.
- Demonstrated understanding of drug development process.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
- Experience in designing Clinical trial strategies to obtain regulatory approval.
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product.
- Ability to develop and evaluate strategies for the clinical development of a designated indication and to critically evaluate outside expert advice.
- Experience in Clinical project planning.
- Experience working on global and complex Clinical trials.
- Experience working effectively in a team/matrix environment.
Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2743. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
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