Exec Medical Director, Global Product Development-Oncology/Hematology - home based

Pharmaceutical Product Development (PPD)

MD-Bethesda-Bethesda MD


Submission for the position: Exec Medical Director, Global Product Development-Oncology/Hematology - home based - (Job Number: 169858)

The HemOnc Therapeutic Area Executive Medical Director is a leadership role that requires proven abilities to drive both strategic innovation and measurable business outcomes. The incumbent’s t rack record of therapeutic expertise will be extensive and ensure recognition of the incumbent as a peer of their Pharmaceutical Industry equivalents. This position will play a key part in the future business success of PPD as it seeks to continue its track record of successful growth and expand its Industry leading position

The role comprises four major functions:

First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs) including: Development strategy and regulatory issues Investigational product class issues Protocol and indication considerations, including safety Team education on indication Interactions with client physicians and/or client TA Head or CMO prior to or during the bid defense Identifying opportunities for PPD® consulting

Secondly, the incumbent is responsible for supporting outstanding input into other areas of PPD’s business activity including:

• Pro-active client engagement: peer-to-peer interaction with CMOs, TA Heads and senior medical directors of companies whose product portfolio contains investigational products of business interest to PPD

• Strategic alliance development & support

• Client governance or advisory boards

• PPD® Consulting practice

• Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans and top-level design of clinical trial protocols that are required in the plan

Thirdly, the incumbent will provide a supporting role in PPD’s Rare Disease strategy team, a cross functional team charged with championing PPD’s business development by creating focused solutions for client companies. Examples of activities related to the development of these integrated business offerings to client companies include:

• Identifying strategic client opportunities

• Client pipeline analysis

• Identifying investigational product opportunities

• Partner with business development to implement specific strategies to grow therapeutic area book of business

• Evaluating and integrating PPD’s service offerings, such as

• Phase 1 first in human testing capabilities

• Clinical trial operations expertise

• Regulatory intelligence expertise

• Laboratory capabilities (including biomarkers)

• Imaging capabilities

• Post-approval studies and outcomes expertise

• Special services – i.e. DSMB management, ARO partnership

Fourthly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal PPD teams including:

· Indication-specific training for clinical teams

· Guidance during clinical trial execution

· Clinical data review and evaluation

· Investigator brochure, clinical study report, NDA/MAA documents, and regulatory briefing documents review and editing

· Contribute to design and reporting of feasibility studies

· Liaise with investigators and KOLs

· Mentor and supervise TA clinical scientists

*LI-LC1

*LI-remote

The HemOnc Therapeutic Area Executive Medical Director is a leadership role that requires proven abilities to drive both strategic innovation and measurable business outcomes. The incumbent’s t rack record of therapeutic expertise will be extensive and ensure recognition of the incumbent as a peer of their Pharmaceutical Industry equivalents. This position will play a key part in the future business success of PPD as it seeks to continue its track record of successful growth and expand its Industry leading position

The role comprises four major functions:

First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs) including: Development strategy and regulatory issues Investigational product class issues Protocol and indication considerations, including safety Team education on indication Interactions with client physicians and/or client TA Head or CMO prior to or during the bid defense Identifying opportunities for PPD® consulting

Secondly, the incumbent is responsible for supporting outstanding input into other areas of PPD’s business activity including:

• Pro-active client engagement: peer-to-peer interaction with CMOs, TA Heads and senior medical directors of companies whose product portfolio contains investigational products of business interest to PPD

• Strategic alliance development & support

• Client governance or advisory boards

• PPD® Consulting practice

• Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans and top-level design of clinical trial protocols that are required in the plan

Thirdly, the incumbent will provide a supporting role in PPD’s Rare Disease strategy team, a cross functional team charged with championing PPD’s business development by creating focused solutions for client companies. Examples of activities related to the development of these integrated business offerings to client companies include:

• Identifying strategic client opportunities

• Client pipeline analysis

• Identifying investigational product opportunities

• Partner with business development to implement specific strategies to grow therapeutic area book of business

• Evaluating and integrating PPD’s service offerings, such as

• Phase 1 first in human testing capabilities

• Clinical trial operations expertise

• Regulatory intelligence expertise

• Laboratory capabilities (including biomarkers)

• Imaging capabilities

• Post-approval studies and outcomes expertise

• Special services – i.e. DSMB management, ARO partnership

Fourthly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal PPD teams including:

· Indication-specific training for clinical teams

· Guidance during clinical trial execution

· Clinical data review and evaluation

· Investigator brochure, clinical study report, NDA/MAA documents, and regulatory briefing documents review and editing

· Contribute to design and reporting of feasibility studies

· Liaise with investigators and KOLs

· Mentor and supervise TA clinical scientists

*LI-LC1

*LI-remote

· MD or equivalent required; subspecialty training in Hematology/Oncology

· Minimum of 10 years of post-education experience in clinical and/or research setting

· Minimum of 5 years of global HemOnc development experience (prefer expertise in 2 of the 3) and 3 years in a leadership role in the pharmaceutical, biotech or CRO Industry

· Excellent verbal and written communication skills

· MD or equivalent required; subspecialty training in Hematology/Oncology

· Minimum of 10 years of post-education experience in clinical and/or research setting

· Minimum of 5 years of global HemOnc development experience (prefer expertise in 2 of the 3) and 3 years in a leadership role in the pharmaceutical, biotech or CRO Industry

· Excellent verbal and written communication skills

Submission for the position: Exec Medical Director, Global Product Development-Oncology/Hematology - home based - (Job Number: 169858)


2021-02-23 00:00:00


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