Top 11469 Site director/physician Jobs

Director, Global Drug Safety & Pharmacovigilance Physician
Genmab —Princeton, NJ
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- Online Application
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Keiser University —Tampa, FL
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Confidential —Panorama City, CA
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11d
Site Medical Director - Vandalia Correctional Center
Centurion Health —Vandalia, IL
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Jordan Valley Health —Lebanon, MO
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Centurion Health —Mountain City, TN
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Northeast Arc —Danvers, MA
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Physical Therapist (Escape the City to Modoc County)
Modoc Medical Center —Alturas, CA
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Premiere Healthcare Staffing —Lewiston, ME
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Physician
Duffy Health Center, Inc. —Hyannis, MA
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Full time Rural Health Advanced Practice Provider (NP/PA)
Beaver Island Rural Health Center —Beaver Island, MI
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- 8 hour shift
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10d

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Director, Global Drug Safety & Pharmacovigilance Physician

Genmab -
Princeton, NJ

Apply Now

Job Details

Full-time
$235,840 - $353,760 a year

Benefits

Commuter assistance
Paid parental leave
Health savings account
Paid holidays
Health insurance
Dental insurance
Tuition reimbursement
Parental leave
Vision insurance
401(k) matching

Qualifications

FDA submissions
Regulatory inspections
Doctor of Medicine
Database systems
Process audits
Pharmacovigilance research
Adverse event reporting
Safety regulations
Triage
Professional development support
Mentoring
Leading team collaboration initiatives
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials
Patient safety and incident reporting systems
Audit support

Full Job Description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned Genmab products throughout their lifecycle management. As Director, you are expected to effectively engage cross-functionally at all levels of the organization, as well as with external stakeholders, including Regulatory Authorities, as applicable. This is an individual contributor role at the Director level, with no direct people management responsibilities. The role reports to the Vice President, MD Team Lead.

You will work together with other Drug Safety staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders supporting the Team Lead. A strong ability to adapt and perform in a dynamic, fast-paced environment is essential to meeting both corporate and patient needs.

This globally focused role involves engagement with a broad range of stakeholders, including regulatory authorities, Data Monitoring Committees, and colleagues across Genmab’s international sites. As Director, GDS & PV Physician, you will be a key member of a highly skilled global team and act as an ambassador for GDS & PV across the organization, including leading education and training on PV principles. A critical aspect of this role is mentoring and developing junior colleagues to enable their success and growth.

Responsibilities

Lead all major pre- and post-marketing safety-related activities including signal, benefit-risk evaluation and risk management activities for own area
Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs and scientific literature; safety reports), ongoing surveillance, and related communication around assigned Genmab products
Oversee handling safety issues and implementing risk mitigation activities, and propose systemic solutions
Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports; eCRFs/CRFs;TMFs) based on review
Prepare relevant documentation (e.g. benefit/risk sections of aggregate reports; safety summaries such as submission modules 2.7.4, clinical overview, etc..) as per regulatory requirements
Manage internal & external forums (e.g. external Data monitoring Committees (DMCs); Genmab Safety Committees) for assigned products
Provide guidance, oversight, and training around safety to relevant stakeholders (e.g. Genmab employees, CROs, Investigators)
Proactively engage with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts and partners around emerging landscape; regulatory authorities around audits and inspections)
Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations

Requirements

MD required
Minimum requirement: 12+ years’ experience in drug safety/pharmacovigilance in clinical development and post-marketing preferably in oncology
Experience with BLA and/or NDA submission, PV audit process with active participation in Regulatory Authority Inspections; and working with the FDA and other regulatory authorities
Experience with global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA and WHODrug coding dictionaries; and individual adverse event case report processing, triage and medical review
Experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems preferred
Experience guiding and mentoring team members
Proven performance in earlier role/comparable role

For US based candidates, the proposed salary band for this position is as follows:

$235,840.00-$353,760.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:

401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Apply Now

Refine Your Search

site director/physician jobs

Director, Global Drug Safety & Pharmacovigilance Physician

Medical Director - Claims

Physician - Hospitalist - Site Director - UH Tripoint

Program Director - Physician Assistant (on-site)

Site Director

Family Physician (MD or DO)

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OTP Medical Provider - Physician, MD

Clinical Pharmacy Specialist Phrm Residency Credentialed SCH

Physician

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Family Medicine Physician

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Primary Care Physician- One Week On/One Week Off

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Physical Therapist (Escape the City to Modoc County)

Travel Med Surg Charge Nurse

Physician

Full time Rural Health Advanced Practice Provider (NP/PA)

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