Medical Director, Early Pipeline, Immunology, GPS

About the role

Purpose: Describe the primary goals, objectives or functions or outputs of this position. Serve independently as the Product Safety Team Lead for one or more assigned products in early development, with accountability for leading safety surveillance, signal detection, validation, assessment, and risk management activities.

Responsibilities

List up to 10 main responsibilities for the job. Include information about accountability and scope. Serves independently as the Product Safety Team Lead for one or more assigned products in early development, providing medical and strategic leadership to the Product Safety Team and driving evidence-based safety decisions.

Integrates pharmacology, chemistry, clinical data, and nonclinical toxicology to lead safety surveillance and inform product safety strategy.

Provides safety oversight for pharmaceutical / biological / drug -device combined investigational products, contributes to the authorship of key pharmacovigilance documents, including but not limited to, development product safety assessments, regulatory responses and risk management plans Interprets and applies current regulatory guidance as appropriate for safety surveillance and authorship of PV documents Leads the analysis and interpretation of safety data and communicates conclusions and recommendations to cross-functional teams and governance bodies.

Effectively writes, reviews and provides input on technical documents.

Leads the strategy for Development Safety Update Reports (DSURs) Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials Leads and implements the risk management strategy for assigned products Supports other Product Safety Team Leads and due diligence projects as needed Interprets applicable pharmacovigilance regulations to guide patient safety activities and cross-functional safety decision-making.

Qualifications & Requirements

MD / DO with 2+ years of residency with patient management experience Pharmacovigilance experience in the pharmaceutical industry preferred Demonstrated ability to analyze and guide the analysis of preclinical, clinical, and epidemiological data. Demonstrated ability to author and critically review technical documents.

Ability to formulate, clearly present, and defend medical safety assessments and recommendations to cross-functional teams and governance bodies.

Work collaboratively in a team environment and be self-starting and able to work independently Fluency, both written and oral, in English Key Stakeholders: Group Head, Executive Medical Director, TA head, PST Lead, Analytics / Data Scientists, Project Management and Data Management, Clinical Development, Preclinical Safety, Precision Medicine, Regulatory Affairs

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.

Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.