Global Medical Indication Lead – Gastro/Autoimmune (US)

Planet Pharma; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Planet Pharma seeks a Medical Doctor to lead the clinical development for a specific indication, translating the TPP into a robust development plan across phases I to registration.

You will manage Global Clinical Trial Physicians, ensure medical integrity, and harmonize communications with IRBs and RA, driving high quality medical support and strategic planning in a global, matrix environment.

Qualifications

• MD with specialty training preferred (e.g., neurology, hematology, dermatology, immunology, rheumatology, internal medicine, pediatrics).
• Fluent English in written and spoken form; ability to travel.
• Proven leadership and interpersonal skills in global, intercultural settings.
• Strong problem-solving and negotiation abilities; ability to influence without direct reporting lines.
• Expertise in clinical trial design, conduct and data interpretation; transparent communication of risk and status.

Responsibilities

• Provide strategic medical insight and planning for the indication across all development stages.
• Line management of Global Clinical Trial Physicians; coach and set example for roles.
• Oversee medical aspects of studies in real time and communicate to management and study teams.
• Ensure harmonisation of communications to external stakeholders (IRBs, regulatory authorities).
• Lead indication medical advisory boards as appropriate.
• Help build a best-in-class group of development medical doctors and ensure compliance across studies.

Skills

Medical Doctor

English proficiency

Leadership

Interpersonal skills

Problem solving

Clinical trial design

Communication

Negotiation

Travel readiness

Education

MD degree

Job description

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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