OverviewWe have a new vacancy forExec Medical Director - Global Product Development (Gastroenterology).The GPD 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 seeks to continue its track record of successful growth and expand its Industry leading position.
Responsibilities

The role comprises four major functions.
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 Therapy Area leaders prior to or during bid defenses
Identifying business opportunities for PPD
Responsible for supporting outstanding input into other areas of PPD’s business activity including :
Pro-active client engagement : peer-to-peer interaction with TA leaders 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
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.
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 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
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 clinical scientists

Knowledge, Skills, and Abilities

Thorough understanding of overall biologic / pharmaceutical product development process, from pre-clinical through post-marketing, including all stages of development and all functional roles
Therapeutic and indication-specific development expertise across one or more therapeutic areas and one or more drug classes, including deep knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape
Thorough understanding of core cross-functional concepts (e.g., preclinical, translational medicine, CMC) and major program requirements at different development stages
Deep knowledge of important regulatory considerations and experience with FDA, EMA and other national regulatory authorities
Experience as a medical strategy leader on one or more asset development teams
Experience with KOL and investigator interactions
Strong decision-making and analytical skills
Excellent communication and influencing skills
Excellent organizational skills and detail-orientated leadership approach
Flexibility to travel domestically and internationally
Ability to work independently on multiple tasks in a fast-paced environment

Education and Experience

MD or equivalent with experience implementing therapeutic programs
Gastroenterology experience required
Direct experience with the creation and implementation of full asset development including pre-clinical, clinical, regulatory, CMC and (if applicable) biomarker strategy development

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