Director\/Associate Director Clinical Science - Gene Therapy

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Job description

Director/Associate Director Clinical Science - Gene Therapy

Job Scope & Purpose:

Our client uses cutting edge gene therapy to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases in many therapeutic targets. They seek a talented Director/Associate Director, Clinical Science to join a growing team.

Primary Job Responsibilities:

• Contribute in collaboration with a cross-functional team to the design and implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the company's portfolio.
• Develop in collaboration with the company's Clinical Development organization and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (Google Cloud Platform) standards/Federal and local regulations and company specific SOPs.
• Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation.
• Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations.
• Assist with study milestones and study metrics in collaboration with clinical operations.
• Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and Google Cloud Platform guidelines.
• Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials.
• Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre- IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required.
• Manage the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans.
• Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program Requirements Knowledge, Skills & Capabilities:
• A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (Google Cloud Platform) is required.
• Experience in Hematology/Oncology, Immunology, or Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy.
• Experience with all phases of clinical drug development including global regulatory submissions preferred.
• Strong communication, organizational and interpersonal skills are required.
• Successful work experience in a matrix team environment with cross functional teams is required.
• Independent decision-making and analytical skills are required.

Primary Job Requirements:

• A minimum of a Bachelors' Degree is required, preferably in a Scientific or Technical Discipline. Advanced degree (MS, RN, PhD or PharmD) is preferred.
• A minimum of 10 years of experience in the Clinical Research & Development Physical & Travel Requirements:
• Ability to travel up to 20% of time both domestic and international

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Code:ClinOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice