Posted on Apr 5, 2021 by Pharmacyclics
Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and study staff.
- Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
- Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
- May oversee the work of Associate or Assistant Scientific Directors and of Clinical Scientists working on the same or related programs.
- Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
- May serve on a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
- Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
- Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Bachelors degree in the sciences; advanced degree (eg, MS, PhD, PharmD) preferred.
- Ability to provide input and direction to clinical research with appropriate supervision.
- At least 4 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to oversee a clinical research program of moderate complexity with minimal supervision.
- Ability to perform and bring out the best in others on a cross-functional global team.
- Ability to interact externally and internally to support a global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
- Must possess excellent oral and written English communication skills.
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