Executive Medical Director / Vice President, Global Product Development - Endocrinology

PPD   •  

Morrisville, PA

Industry: Biotech/Pharma

  •  

11 - 15 years

Posted 295 days ago

This job is no longer available.

143981

The Endocrinology leadership role requires proven abilities to drive both strategic innovation and measurable business outcomes. The incumbent’s track 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 seeksto 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
  • Drug class issues
  • Protocol and indication considerations, including safety
  • Team education on indication
  • Interactions with client physicians and/or client TA Head 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 TA Heads and senior medical directors of companies whose product portfolio contains drugs 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 Therapeutic Area Strategic Team (TAST), 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 drug 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

Qualifications

 

Prior Experience and Education Requirements:

  • MD or equivalent required; subspecialty training in Endocrinology
  • Minimum of 10 years of post-educationexperience in clinical and/or research setting
  • Minimum of 5 years of global Diabetes drug development experience and 3 years in a leadership role in the pharmaceutical or CRO Industry
  • Excellent verbal and written communication skills