Medical Director Cardiopulmonary - MD

for the compliance of the assigned clinical study(ies) with department, company and regulatory standards and procedures In this role, the incumbent represents the medical lead for the specific assigned project(s) in the Clinical Team (CT). The Medical Director Cardiopulmonary may act as Study Responsible Physician (SRP) and lead the CFTT together with the Global Trial Leader (GTL).

General Activities

• Accountable for executing the Clinical Development Plan (CDP): providing medical input, oversight and guidance on assigned Clinical Development Programs and their execution from conception of strategy to design, implementation, execution, and submission / approval.

• Provide support (with medical and scientific input) to strategic decisions of the Compound Development Team (CDT) for assigned project(s).

• May be responsible for site interactions in partnership with the Study Responsible Scientist (SRS) for medical questions and education (including safety management guidelines).

• Provide clinical/ scientific content for submissions to regulatory agencies and IRBs/ ethics boards, answer to medical/ scientific questions from Health Authorities and be the company clinical expert at meetings with them. Ensure production of high-quality documents.

• Performs medical data review, including evaluation of adverse events and eligibility of participants for assigned studies.

• Responsible for assessment of key safety-related serious adverse events in partnership with the Local Safety Officer and the Medical Safety Officer and oversees safety narratives.

• Lead medical aspects of study-related committee (e.g. clinical advisory boards, steering committee, data monitoring committees) interactions.

• Ensure that all activities are in compliance with department, company and regulatory standards and procedures.

• As requested, participates on cross functional teams for evaluation of new product ideas, implementation of business strategies, improvement of processes, etc.

• Maintain personal knowledge of assigned therapeutic indication(s).

• Additional tasks may be assigned to enhance development

• May act as Senior Clinical Project Physician (SCPP) and provide medical leadership, oversight and guidance on clinical development project(s) under his/her responsibility from concept generation to design, implementation, execution, and submission/approval

• May act as Molecule Responsible Physician (MRP).

• May deputize for the Executive Medical Director

• May be involved in regional initiatives to support recruitment and/or patient retention

• Provides leadership, direction, and employee development as assigned including: - Senior Medical Manager

Qualifications

We would love to hear from YOU, if you have:

Essential

• Medical Doctor (MD) with ≥ 8 years experience in Clinical Development. Clinical research experience in the indication relevant to the Clinical Project is preferred.

• Sound knowledge of drug development and clinical trial process based on previous deliverables and sound knowledge of regulatory requirements/ ICH guidelines

• Experience in leading projects successfully, and managing internal and external stakeholders

• Experience in managing projects and/or initiatives to improve efficiency/quality of internal processes.

• Good computer systems and software skills.

• Excellent English, other languages advantageous.

Key competencies required

• Strong leadership skills and strategic thinking.

• Demonstrated analytical and problem-solving skills with strong ability to persuade and influence at the project team level and management level.

• Good organizational skills, able to work collaboratively as part of a team in a matrix environment and independently.

• Excellent written and verbal communication skills.

• Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.

• Demonstrated ability to think strategically.

Key Working Relationships Cross-Functional Team:

Regulatory Lead, Global Program Leader, Program/Study Statistician, GTL, Clinical Scientists (i.e. SRS), Clinical Trial/ Project Physicians (i.e. Study Responsible Physician) Internal: Clinical Pharmacology, Global Development and Clinical Operations, Health Economics & Pricing, Global Medical Safety, R&D Project Management Organization, BioResearch Quality External: Vendors and CRO contacts, academic thought leaders, FDA, European and other health authorities as appropriate. Supervision: This position reports to the Executive Medical Director.

This is what awaits YOU at J&J:

• An opportunity to be part of a global market leader.
• A dynamic and inspiring working environment.
• Many opportunities to work on challenging projects and assignments.
• Possibilities for further personal as well as professional development.
• Many employees benefits.