Associate Director, Early Clinical Scientist (Hybrid)

Job Description

The Early Clinical Scientist/ECS provides leadership and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team members. Responsible for oversight, strategic direction and implementation of multiple trials within and/or across program(s)/therapeutic areas and developmental stages. Ensures excellence in execution and compliance to support study objectives and data validity. Ensures consistency for all clinical program elements. Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise.

Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

Represents Early Stage Development on early development and product development teams. Directs the development of departmental job aids/SOPs and participates in or leads cross-functional teams to develop global clinical development procedures. Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures. Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities. Represents the company at professional events and may present company clinical initiatives, projects, and/or clinical trial results.

Technical Writing & Communications

Responsible for authoring of clinical protocols, clinical investigator brochures, clinical study reports, regulatory agency update reports, responses to regulatory agencies, responses to audits/inspections, and other clinical and regulatory documents. Author and coordinate the development of Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections. Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations, due diligence activities, etc. Ensures documents are completed in accordance with applicable standards. Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.).

Project Management

Leads and directs teams in key study planning, development and execution elements (e.g., program level overviews, issue escalation/mitigations, presentations at Sr. Management meetings, program level cross-functional meetings and governance, advisory meeting preparation). Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines. Thorough understanding of early drug development processes, applying knowledge and skills to effectively manage additional processes/procedures.

Education Minimum Requirement:

• Degree in Life Sciences

• Bachelor’s degree and ≥11 years related* experience, OR

• Master’s degree and ≥8 years related* experience, OR

• PhD or doctorate degree and ≥3 years related* experience

• *e.g., familiarity with or knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments for drug candidates (protocol authoring, experiment execution/oversight, authoring experiment reports).

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your sepa