Exec Med Dir, Global Product Development

vor 3 Wochen

Nuernberg, Deutschland Thermo Fisher Scientific Vollzeit

At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme ensuring you reach your potential.

We have a new vacancy for **Exec 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.

**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

**Our 4i values**

**Integrity - Innovation - Intensity - Involvement**

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