ED&CP Regional Site Strategy Lead

Position Summary:

The Early Development and Clinical Pharmacology (ED&CP) Regional Site Strategy Lead (SSL) is accountable for the strategy to build and leverage investigator site capabilities and capacity for ED&CP trials in designated area / countries. This role will support program and study level country / site recommendations during feasibility and ensure effective country/site allocations.

The ED&CP Regional SSL will evaluate Janssen ED&CP portfolio needs with local GCO resources, PDO, TA, FCOE, and other stakeholders to develop and implement strategies / techniques to identify, assess and deploy new / existing sites with appropriate capabilities, infrastructure, staffing and capacity. Directly support feasibility and site selection processes and strategy with consideration of program / study needs as well as country / regional considerations. The ED&CP Regional SSL will create and execute strategies for strong site relationships to leverage in study planning and execution.

The ED&CP Regional SSL will ensure there is strategic approach to connecting with key stakeholders and developing GCO recommendations for study / site feasibility as well as allocations endorsed by the ED&CP Regional Heads (regionally and globally) in alignment with relevant SOPs, TA strategies, and GCO level strategic site development approaches / objectives. This includes approaches to identify and qualify sites, which will meet requirements for study delivery.

The ED&CP Regional SSL will directly collaborate with Portfolio Delivery Team, Therapeutic Area as well feasibility and local country operations to identify appropriate strategy and tactics for the region assigned. The ED&CP Regional SSL will collaborate with investigators, KOLs and site operation leaders within the regions to facilitate development of strong site relationships supporting complex study execution and novel drug delivery.

The ED&CP Regional SSL requires direct experience with clinical trial strategic planning / execution, including ED&CP clinical operations expertise, a deep understanding of sites/ study set up, plus understanding of regional regulations and health care systems.

Principal Responsibilities:

1. Defines and leads implementation of GCO ED&CP site development and engagement strategy in assigned area, aligned with country capabilities and the Janssen ED&CP R&D strategies. This will require proactive planning and effective site strategy development actions. Ensures site development, engagement and study placement strategies are endorsed by the ED&CP Regional Heads in alignment with regional strategies, FCOE and PDO.

2. Ensures early alignment with key stakeholders including SRPs, SRS/CSs, GPLs, GTLs, IPPI team, Feasibility Centre of Excellence with country outreach and site feasibility assessment.

3. Defines and deploys techniques, communications, and approaches to develop evolving list of core sites (may be unique to each TA) to meet current and future needs of portfolio (TA and study type). Supports decision making for allocation and utilization of core sites with consideration of program / portfolio considerations and ED&CP Footprint, resourcing and allocation strategy.

4. Acts as a Subject Matter Expert with regional expertise in Early Development for site selection, start-up and study execution.

5. Supports study operational ED&CP specific requirements in collaboration with ED&CP TMs (Local Operation Liaisons), KOLs and site leadership in alignment with the TA and PDO leadership.

6. Partners to assess protocol and institutional capabilities to ensure operational complexities are addressed. Ensures future list of sites with ED proficiencies and capable of meeting expedited timelines are available for program and study level feasibilities.

7. Consolidates information from the countries and sites in collaboration with Local Country Operations (i.e., ED&CP TMs, local Operation Liaisons, FMs, FCOE) in development of the study execution strategy and milestone targets including any broader risks for consideration in mitigation plans.

8. Supports local GCO teams to leverage site specific knowledge and relationships in planning / conduct of trials.

9. Supports local GCO teams to provide regional and site information for discussion with TA and PDO in portfolio review and TA consensus meetings.

10. Shares updated information from portfolio review meetings with the ED&CP FMs and Regional Heads in preparation for upcoming trial consensus meetings.

11. Provides input and supports development of program / study level commitments for study deliverables.

12. Ensures appropriate and timely escalation of issues related to study placement to GCO ED&CP Regional Head.

13. Strongly demonstrates Leadership Behaviors in alignment with Leadership Imperatives

14. Fosters an environment that encourages the sharing of ideas, information, and best practices (internal and external to the organization) in the region including evaluation of performance metrics.

15. Builds strong relationships with ED&CP Functional Managers,, ED&CP Local Operating teams, IPPI team, Portfolio Delivery Operations (PDO and the ED Unit), FCOE and other internal/external business partners as required.

Principal Relationships:

Primary Reporting Structure: Reports to GCO Regional Head ED&CP.

Primary interfaces: GCO ED&CP Functional Managers, GCO ED&CP Regional Heads, ED&CP Regional SSLs, GCO ED&CP TMs, ED&CP SMs, CTMs, GTLs, GPL, PDO Operations Head, SRPs, SRS, GFLs/Feasibility CoE, TA Representatives/Clinical Teams

Other Internal Interfaces: Medical Affairs, Integrated Data Analytics and Reporting (IDAR), Global Regulatory Affairs, Bioresearch Quality and Compliance (BRQC), Contract and Compliance Services (CCS), Quality & Compliance Managers/Specialists Clinical Supplies Unit (CSU),, ED&CP Business Operations and others as required

External Interfaces: Investigational sites, CRO Functional Management, Health Authorities, Local Pharma Industry Associations

· Bachelor's degree or equivalent is required. A degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is preferred.

· Minimum of 8 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site is required. ED&CP previous clinical trial experience is preferred.

· Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations is required.

· Ability to build strong internal and external partnerships is required.

· Effective leadership skills, ability to develop and implement strategies, and to foster team productivity and cohesiveness is required.

· Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.) is required.

· Flexible mindset and ability to work at a fast paced in a fast-changing environment in different therapeutic areas is required.

· Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment is required.

· Solid decision-making skills.

· Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues is required.

· Ability to synthesize and evaluate data generated from various reports and sources is required.

· Operates under limited supervision.

· Proficient in English language and computer literacy.

· Strong interpersonal and negotiating skills are required.

Travel: