Vivid Resourcing
Overview
Job Title:
Medical Director Clinical Development (Oncology) Employment Type:
Full-Time, Permanent Industry:
Pharmaceutical / Biotech Oncology Location:
Hybrid role with 23 days onsite per week in the Raleigh-Durham area. About the Company
Our client is an innovative
biopharmaceutical company
committed to developing breakthrough oncology therapies that address unmet patient needs. With a strong clinical pipeline and a collaborative research culture, they are expanding their
Clinical Development team
to support ongoing and upcoming oncology trials. Position Overview
As a
Medical Director Clinical Development (Oncology) , you will provide
medical and scientific leadership
for clinical programs across early- and late-phase oncology trials. Youll play a key role in
study design, execution, medical monitoring, data interpretation, and regulatory interactions , working cross-functionally with clinical operations, biostatistics, pharmacovigilance, and regulatory affairs. Key Responsibilities Serve as
medical lead
for oncology clinical trials (Phase IIII), ensuring scientific and clinical integrity of study protocols and execution. Author and review
clinical development plans, protocols, investigator brochures, and regulatory submissions (IND, NDA, BLA) . Provide
medical monitoring
for ongoing studies, including safety oversight, adverse event evaluation, and data review. Partner with
clinical operations and project management
to ensure timelines, quality, and compliance with GCP/ICH guidelines. Collaborate with
biostatistics and data management
on analysis plans and interpretation of clinical data. Contribute to
regulatory strategy
and participate in meetings with FDA and other health authorities. Support
publication strategy
and present clinical data at internal and external scientific meetings. Provide
medical/scientific guidance
to cross-functional project teams and external investigators.
Qualifications
MD, DO, or equivalent medical degree
(oncology, hematology, or related specialty preferred). Minimum
35 years experience
in clinical development within the pharmaceutical or biotech industry. Proven track record in
oncology clinical trials
(early- or late-stage). Strong understanding of
GCP, ICH guidelines, and US regulatory environment . Excellent communication and leadership skills, with the ability to influence cross-functional teams. Board certification in
Oncology, Hematology, or related discipline . Experience in
regulatory interactions (FDA, EMA, etc.) . Experience in both
early-phase and pivotal studies . Annual
performance bonus
and
long-term equity incentives . Generous
PTO and flexible hybrid working model .
Job Details
Seniority level: Director Employment type: Full-time Job function: Science Industries: Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Annual performance bonus Long-term equity incentives Generous PTO and flexible hybrid working model
#J-18808-Ljbffr
Job Title:
Medical Director Clinical Development (Oncology) Employment Type:
Full-Time, Permanent Industry:
Pharmaceutical / Biotech Oncology Location:
Hybrid role with 23 days onsite per week in the Raleigh-Durham area. About the Company
Our client is an innovative
biopharmaceutical company
committed to developing breakthrough oncology therapies that address unmet patient needs. With a strong clinical pipeline and a collaborative research culture, they are expanding their
Clinical Development team
to support ongoing and upcoming oncology trials. Position Overview
As a
Medical Director Clinical Development (Oncology) , you will provide
medical and scientific leadership
for clinical programs across early- and late-phase oncology trials. Youll play a key role in
study design, execution, medical monitoring, data interpretation, and regulatory interactions , working cross-functionally with clinical operations, biostatistics, pharmacovigilance, and regulatory affairs. Key Responsibilities Serve as
medical lead
for oncology clinical trials (Phase IIII), ensuring scientific and clinical integrity of study protocols and execution. Author and review
clinical development plans, protocols, investigator brochures, and regulatory submissions (IND, NDA, BLA) . Provide
medical monitoring
for ongoing studies, including safety oversight, adverse event evaluation, and data review. Partner with
clinical operations and project management
to ensure timelines, quality, and compliance with GCP/ICH guidelines. Collaborate with
biostatistics and data management
on analysis plans and interpretation of clinical data. Contribute to
regulatory strategy
and participate in meetings with FDA and other health authorities. Support
publication strategy
and present clinical data at internal and external scientific meetings. Provide
medical/scientific guidance
to cross-functional project teams and external investigators.
Qualifications
MD, DO, or equivalent medical degree
(oncology, hematology, or related specialty preferred). Minimum
35 years experience
in clinical development within the pharmaceutical or biotech industry. Proven track record in
oncology clinical trials
(early- or late-stage). Strong understanding of
GCP, ICH guidelines, and US regulatory environment . Excellent communication and leadership skills, with the ability to influence cross-functional teams. Board certification in
Oncology, Hematology, or related discipline . Experience in
regulatory interactions (FDA, EMA, etc.) . Experience in both
early-phase and pivotal studies . Annual
performance bonus
and
long-term equity incentives . Generous
PTO and flexible hybrid working model .
Job Details
Seniority level: Director Employment type: Full-time Job function: Science Industries: Pharmaceutical Manufacturing and Biotechnology Research
Benefits
Annual performance bonus Long-term equity incentives Generous PTO and flexible hybrid working model
#J-18808-Ljbffr