Provide expert guidance on Adobe's AEM Cloud services, ensuring successful customer transitions and optimizations. Collaborate closely with internal teams and clients for exceptional service delivery.
About the role
- Clinical Pharmacology Lead managing drug development strategies in Internal Medicine. Working with multifunctional teams to optimize clinical pharmacology methodologies and regulatory compliance.
Responsibilities
- Act as Clinical Pharmacology representative on Clinical Sub Team, Development Team and other multifunctional teams as appropriate
- Responsible for providing expertise, leadership, and deliverables of clinical pharmacology for the assigned projects within sphere of influence
- With some guidance, design and execute clinical pharmacology plans and implement clinical pharmacology best practices on project teams
- Work closely with other disciplines to ensure that sufficient preclinical PK/PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model prior to FIH
- With some guidance, responsible for planning and overseeing clinical pharmacology aspects at the project level (e.g clinical development plan, implementation and interpretation of PK/PD analyses, PK/immunogenicity/biomarker measurement strategies etc.)
- Plan and oversee study level activities including protocol authoring, clinical phase oversight, and reporting
- With some guidance, responsible (with clinicians and statisticians) for ensuring appropriate dose-range finding strategies which ultimately will lead to optimal doses and dosage regimens in patients
- Accountable for ensuring appropriate design and implementation of End-to-End MIDD plan that conforms with best practices
- Responsible for ensuring use of innovative analytical methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs
- With some guidance, provide End-to-End clinical pharmacology contribution to regulatory documents (e.g., Briefing documents, Regulatory queries, Investigator’s Brochures, IND, NDA/MAA, etc.)
- Stay abreast of literature, regulatory guidelines, and internal guidances and SOPs
- Influence external environment through publications, presentations, and representation at scientific societies and industrial consortium.
Requirements
- Pharm. D., M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline
- Strong quantitative skills and expertise (e.g. experience in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.)
- 0+ years of industry experience
- Excellent written and verbal communication skills
- Demonstrated presentation skills
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including the ability to influence and collaborate with peers to achieve meaningful outcomes and create business impact.
Benefits
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Leader of Biomass Business Unit at Axpo managing strategic development and operational efficiency. Overseeing a team of 130 across 25 locations in Switzerland.
Senior UX Research Manager at Etsy leading research and guiding product strategy for the Core Seller Experience team. Collaborating across product, design, and engineering to enhance seller - facing initiatives.
General Manager managing U - Haul moving and storage center operations, ensuring profitability and efficiency through staff management and inventory oversight.
Market Support Manager building strong client relationships via effective communication and project management at Infinite Digital. Responsible for managing client projects and ensuring timely completion.
Store Manager at SmartStop Self Storage managing leasing, team, and tenant relations. Responsibilities include maintenance supervision and ensuring customer satisfaction in Bernalillo, NM.
Repair Quality Manager ensuring high standards in property repairs and claims management. Playing a vital role in disaster recovery within the insurance industry.
Manager, Analytics & Insights at GSK driving cutting - edge workforce analytics and insights for improving organizational effectiveness. Collaborating across teams to optimize talent management and data integrity.
Enterprise Access & Reimbursement Manager focused on Hematology, Oncology, and Cardiovascular portfolio. Collaborating with healthcare providers to ensure patient access to BMS medications.
Enterprise Access & Reimbursement Manager at Bristol Myers Squibb supporting hematology and oncology. Responsible for building relationships with healthcare providers and ensuring patient access to medications.