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Deborah C. Email & Phone Number

Medical Monitor/Clinical Executive/Acting Director Clinical Scientist at inSeption Group
Location: United States 8 work roles 2 schools
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Current company
Role
Medical Monitor/Clinical Executive/Acting Director Clinical Scientist
Location
United States
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Deborah C. is listed as Medical Monitor/Clinical Executive/Acting Director Clinical Scientist at inSeption Group, a with 59 employees, based in United States. AeroLeads shows a matched LinkedIn profile for Deborah C..

Deborah C. previously worked as Clinical Executive/Medical Monitor/Clinical Scientist at Inseption Group and Medical Monitor at Collab Infotech. Deborah C. holds Ms, Criticial Care Adult Nurse Practitioner from Stony Brook University.

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inSeption Group

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About Deborah C.

I am a Nurse Practitioner with over a decade at the bedside in Oncology and Critical Care. I transitioned to the Pharmaceutical industry where I started as a CRA and progressed to management as an Early Oncology Global Program Leader and assumed multiple leadership roles as a Clinical Scientist leading multiple early and late phase programs for solid and liquid tumors as well as complex translational medicine and imaging protocols in Oncology drug development trials. Transitioned to Medical Affairs as Medical Science Liaison and internally as Medical Affairs Manager.Specialties: Solid Tumors and tumor specific for Breast, CRC, Lung, HNK, GI, Liver, Melanoma, Ovarian and Renal Renal. HER2 MSL, Clinical Development and Medical Affairs, Thought Leader Development, Pre Clinical Drug Discovery, Early and Late Phase Clinical Research, Oncology, Hematology, Immunology, Immuno-Oncology, Anesthesia, Critical Care, Pain Management, Cardiovascular, Radiology (IR, CA and Imaging), Next Generation Sequencing Expert Early Development Oncology Clinical Scientist and Early Development Program Leader for Small Molecule and MAB including Clinical Pharmacology, Imaging and Translational Medicine, Biomarker sub trials and companion diagnostics. Lead two programs to fast track status for late stage development through project management skill sets and daily hands on clinical site management. Development of associated internal and external training in order to facilitate early review of clinical data and adverse events for Go/No-Go decision making. Selection and management of full service CRO’s with budgetary allocations >25 mill USD and specialty vendors with budgetary allocations < 1 mill USD.Management Strength: Successful collaborator, facilitator and team player with proven track record in building relationships with stakeholders that foster negotiation for “buy in” with national and international cross functional team members in order to meet milestones and decrease cost utilizing PMBoK standards.

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inSeption Group
Inseption Group
Medical Monitor/Clinical Executive/Acting Director Clinical Scientist
lansdale, pennsylvania, united states
Employees
59
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8 roles · 26 years

Deborah C. work experience

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Clinical Executive/Medical Monitor/Clinical Scientist

Current

Philadelphia, Pennsylvania, United States

Remote worker...great company and values. -Phase I-IV expertise in small molecule, MAB, I-O, T-Cell and NK Cell Therapy.- Generate scientific and clinical development documents with appropriate matrix team input to support the established development strategy: Product Development plans, Medical Review Plans and/or Clinical Development plans.- Assist with setting study strategy to enable effective study delivery and implementation.- Oversight of operational aspects of clinical trials including protocol development, investigator recruitment, patient enrollment, study specific guidelines and processes and quality of data collection.- Defines scope of work within projects, resource needs and allocation.- Coordinates and ensures consistency of study specific templates/guidelines.- Data Cleaning focusing on NDA submission and DMC as well as expert in dose escalation studies and basket studies.

May 2021 - Present

Medical Monitor

Remote

Medical Monitor/Clinical Scientist supporting anti-LAG3 and anti-PD-1 combination studies. Member of multiple SWAT teams responsible for medical review of data and scientific reporting for multiple database locks.

Jun 2020 - May 2021

Medical Science Liaison - Oncology

United States

Identification of strategic solutions through scientific and strategic relationships with key, influential physicians and scientists as well as community based organizations, academic centers of excellence, and major medical association in order to establish long term relationships. Disseminate clinical and technical information. Identification of investigator concepts leading to potential post marketing studies. Provide medical and clinical information to healthcare professionals upon request in a timely, ethical and customer-focused manner.

Sep 2018 - Sep 2019

Clinical Scientist/Clinical Liaison

Independent Clinical Development Consultant

Medical Writing – Protocol, Amendments, Informed Consents, Case Report Forms, Clinical Summary Reports, and Interim Reports.Program strategy, clinical trial management, and translational medicine.Database cleanup in preparation for database lock.Vendor contract review to reduce expenditures and identification of waste. Directed teams and assisted in the authoring and development of remediation plans and incorporation of project management skillsets enabling project teams to streamline clinical enrollment process. Member of teams responsible for FDA interface.Clinical representative for regulatory submissions.Clinical representative to Study Drug Work Stream for development of global commercial drug launch plan.

Oct 2007 - Jul 2018

Medical Science Liaison

Greater Los Angeles Area

Identification of scientific and strategic relationships with key, influential physicians and scientists as well as community based organizations, academic centers of excellence, and major medical association in order to establish long term relationships. Disseminate clinical and technical information. Identification of investigator concepts leading to potential post marketing studies. Provide medical and clinical information to healthcare professionals upon request in a timely, ethical and customer-focused manner. Identify and establish thought leaders and opinion leaders for the West Coast territory Customer support for information requested to support Pharmacy and Therapeutic Review process in alignment with guidelines for local and national accounts.Develop and maintain collaborative relationships with current and future industry leaders to identify scientific communication opportunities. Respond to Health Care Practitioner Medical Information requests for on label and off label information as set for by FDA guidance for industry.Represent organization at Advisory Boards, Medical Congresses and Annual Medical Conventions.Provide guidance and support in development of investigator initiated studies and when approved conduct organizational follow up for accrual, completion, and publication.Communication of relevant information from KOLs and thought leaders to key cross-functional partners.Developed KOL Identification and Training for MSL team.One on one interaction, small group discussion, and presentation of research protocols.

Jun 2013 - Jun 2014

Clinical Research Study Manager

Program Manager for domestic and international Phase I/II oncology trials responsible for trial activities based upon formal life cycle management consistent with the PMBoK project life cycle, tools, techniques, and required documentation. Participated in full governance review of trials in order to meet and/or exceed key review milestones.

Nov 2006 - Oct 2007

Clinical Program Manager

Project Manager of 20-person cross functional team responsible for liaising between clinical operations and corporate functional groups for humanized IgG1k class monoclonal antibody that targeted CD2 expressing T- and NK-cells. Developed effective communication strategies and initiatives relevant to global Clinical Research Organization. Five direct reports with $1.5M program budget.

Jun 2006 - Nov 2006

Clinical Scientist

Early Program Operations Lead for VEGF inhibitor with dual role of operations and scientist. Functionally, lead multiple 25-person international matrix teams working with large and small molecules for multi-million dollar programs. Biomarker planning and validation. Authored first pharmacogenomic endpoint study in Breast Cancer for organization.

2001 - 2006 ~5 yrs
Team & coworkers

Colleagues at inSeption Group

Other employees you can reach at inseptiongroup.com. View company contacts for 59 employees →

2 education records

Deborah C. education

Ms, Criticial Care Adult Nurse Practitioner

Activities and Societies: Sigma Theta Tau ASCO RAPS

FAQ

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What company does Deborah C. work for?

Deborah C. works for inSeption Group.

What is Deborah C.'s role at inSeption Group?

Deborah C. is listed as Medical Monitor/Clinical Executive/Acting Director Clinical Scientist at inSeption Group.

Where is Deborah C. based?

Deborah C. is based in United States while working with inSeption Group.

What companies has Deborah C. worked for?

Deborah C. has worked for Inseption Group, Collab Infotech, Indegene, Independent Clinical Development Consultant, and Guerbet.

Who are Deborah C.'s colleagues at inSeption Group?

Deborah C.'s colleagues at inSeption Group include Dina Dunn, Stephanie Cain, Patti Smith, Gloria Pitts, and Karin Rezzonico Rqap-Gcp.

How can I contact Deborah C.?

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What schools did Deborah C. attend?

Deborah C. holds Ms, Criticial Care Adult Nurse Practitioner from Stony Brook University.

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