Global Medical Indication Lead – Gastro (US)

Planet Pharma Group; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Planet Pharma seeks a Medical Doctor to lead the clinical team for a given indication, translating the Therapeutic Potential Profile into a Clinical Development Plan while safeguarding time, quality and budget.

You will oversee the medical aspects of studies, manage Global Clinical Trial Physicians, ensure harmonised communications with IRBs/RA, and guide medical advisory boards as part of building a top-tier development medical group at Planet Pharma.

Qualifications

• Medical Doctor with relevant specialty education preferred.
• 3–5 years in pharma/biotech industry.

Responsibilities

• Provide strategic medical insight and planning across all development stages.
• Own the Clinical Development Plan and participate in long-range strategic planning as data emerge.
• Line manage Global Clinical Trial Physicians; coach high performers.
• Real-time oversight of medical aspects of studies and communications to management and study teams.
• Safeguard harmonisation of communications with external stakeholders and across studies.
• Lead indication medical advisory boards as appropriate.
• Help build and maintain a best-in-class development medical group.
• Ensure compliance of all studies in the indication.

Skills

Medical Doctor

Leadership

Clinical development

English proficiency

Education

Medical Doctor (MD)

Job description

Position purpose

Leads the clinical team for an indication: translating the TPP as set by the Asset Strategy Team into a Clinical Development Plan that answers the relevant questions safeguarding time, quality and budget, in close collaboration with the other members of this cross functional team, in order to maximise the potential of the Asset for a given indication .

Key Accountabilities/Responsibilities:

1. Provide continuous strategic medical insight and planning for the indication during all the stages of development. Own the Clinical development plan.Participate in long range strategic planningas data emerge in the indication
2. Line management of the Global Clinical Trial Physicians working on the indication :coachand set examplefor their roles ensuring high quality medical support for thestudy teams, identify high performers for potential other roles
3. Real time oversight of the medical aspects of studies in the indicationincluding the relevant communication to management as well as the different study teams
4. Safeguard harmonisation across the studies so that communications to external stakeholders ( e.g. questions of IRBs, RAs) are consistent and company efficiency is maintained in close collaboration with peers as well as management of the different functional groups.
5. Lead indication medical ad boards as appropriate
6. Help build and maintain a “best in class” group of development medical doctors
7. Ensure complianceof all studies in the indication

Desired Skills and Experience

• Medical Doctor; relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine, pediatric, ), having acquired in-depth understanding of end to end ( phase I to registration) drug development based on relevant experience of at least 3-5 years in the pharma/biotech industry.

• Excellent English, both written and spoken is a must, as well as ability to travel.
• Proven leadership, motivational and interpersonal skills in a global and intercultural environment , including leading through influence ( without having direct reporting lines).
• Pro-active problem solver with negotiation skills
• Must provide clear vision, direction, and purpose to the different study teams, Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
• Strong communication skills to ensure that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,
• Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity, being an accomplished team player whilst maintaining medical integrity
• Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data