Associate Director, Translational Clinical Medical

2 weeks ago

Spring House, United States Johnson & Johnson Full time

Johnson & Johnson is recruiting for an Associate Director, Translational Clinical Medical Lead (TCML), Immunology Translational Sciences and Medicine (TSM) to be located in Spring House, PA.

The primary focus of this Associate Director, Translational Clinical Medical Lead (TCML) position within the Clinical Science Group within the Immunology Translational Science and Medicine (TSM) department is to lead the safety strategy; develop the medical review and oversight plans and conduct medical surveillance and interpretation of safety findings for clinical pharmacology (CPP) and Early Development (ED) studies as outlined in the asset clinical development plan (CDP).

For TSM Accountable studies the TCML will lead and be the responsible for study planning, execution and communication to TSM leadership, Asset Lead and CDT (compound development team) as needed. The TCML will partner with the CPP lead on CPP owned study design, protocol development and execution, being accountable for the medical monitoring and safety strategy of these trials.

This work is at its core a deep collaboration between Disease Area experts, CPP, Clinical and Non-Clinical Safety, Translational Science (Biomarker), Translational Medicine (Clinical) experts, Immunologic Pathway experts and other relevant stakeholders at the CDT. The TCML collaborates with Global Development Operations (GDO) and the entire Trial Team to operationalize studies efficiently and effectively.

PRINCIPAL RESPONSIBILITIES:

- Functions as the clinical lead with MM role responsibilities on clinical pharmacology and other ED studies, as needed.
- Serves as Global study responsible physician (SRP) and maintains oversight for ethnic bridging studies in partnership with the local teams.
- Identifies and assesses medical risks and mitigation plans prior to and during clinical trials.
- Follows Janssen SOPs for the SRP function including development of medical review plans; medical input and development of protocol elements document (PEDs), protocols, Informed Consent Form (ICF), Case Report Forms (CRF), Top Line Results (TLRs), Clinical Study Reports (CSRs); owner of safety sections of key documents (DSURs, CSRs, briefing books, etc.)
- Evaluates safety in support of dose escalation safety data reviews and decision making.
- Interacts with regulatory authorities and external stakeholders (study Investigators/ /Vendors)
- May participate on early development CDTs to contribute to and communicate strategic asset information relevant to the study design and at key meetings (e.g., CDT, Protocol Review Committee (PRC), First in Humans Early Development Committee (FIHEDC)

STUDY RESPONSIBILITIES:

- Addresses questions and comments on protocol design at Protocol Review Committee meetings (PRC).
- Ensures study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and Janssen standard operating procedures.
- Regularly surveils/assesses safety in ongoing clinical studies (e.g., prepare and archive medical monitoring reports)
- Communicates SUSAR case digests with GMS and/or other SRPs.
- Performs routine (e.g., biweekly or monthly) AE and CM coding reviews.
- Reviews SAE/severe AE case studies with principal investigators as necessary.
- Responsible as an owner of safety sections of key documents such as CSRs.
- Presents trial design, trial conduct updates, and top line results for assigned studies to management.

In collaboration with other functions in GDO:

- Participates in study feasibility, CRO/site selection, trial preparation, initiation, conduct, monitoring, and database locks.
- May review the scope of work for vendor contracts (e.g., medical monitoring), for accuracy of work outputs.
- May lead the MM outsourcing strategy (e.g. vendor selection, definition of scope of work, contracting and budget).
- Reviews incoming data from the study for accuracy and completeness; responsible for data review in conjunction with other clinical team members prior to database locks (iDARTS/Spotfire, listings etc.)
- Supports the assessment and review of clinical safety data from studies by collecting and summarizing appropriate safety data/information for review by the Molecule Responsible Physician (MRP) and/or Safety Management Team (SMT).
- Reviews and interprets clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
- Contributes to the safety sections of the clinical study report and assures the overall integrity of the data presented in the CSR.
- Contributes to updates of the IB (Investigator Brochure) and regulatory documents (e.g., Briefing books, scientific advice meetings, DSURs).
- Reports the status of clinical trials to management.

**Qualifications**:

- Physician (MD or equivalent required).
- 3 years or more of clinical experience. Relevant work experience as Medical Monitor, and/or pharmacovigilance and/or drug safety officer in a CRO, pharma/b

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