Job Description

Description:

• In collaboration with the HoM and other AHoMs, exert medical and scientific strategic leadership for the Therapeutic Area, with a focus on assets within his/her area of responsibility.
• Maintain and spread knowledge of scientific developments, (products, mechanisms, methodologies) competitor strategies and external environment developments within his/her area of responsibility.
• Ensures alignment regarding scientific platforms, medical communication and publication strategies as well as the Product Maintenance and Optimization strategies for each substance or project under their responsibility as delegated by TA HoM.
• Review and approve final Clinical Trial Reports, Clinical Trial Protocols, scientific publications according to established procedures as delegated by the TA HoM.
• Ensures the review of the Master Plans, related Clinical Development plans and Clinical Trial Protocols and programmes, by the CEG for each substance or project under their responsibility as delegated by TA HoM.
• Key decision maker in internal committees with regard to the his/her area of responsibility (e.g. Member of Clinical Expert Groups (CEG), contribute to and co-ordinate medical/clinical contributions to pre-clinical research, development and translational medicine as well as MedicoMarketing strategy and project-related documents (as responsibility for his/her products require).
• Provide consultation to the International Labelling Committee (ILC) in their obligation to maintain marketed products.
• Serve as a member of the Therapeutic Area Licensing Advisory team, responsible for preliminary, clinical evaluation of in-licensing opportunities and oversight of in-depth inlicensing evaluations as delegated by the TA HoM.
• Manage employees belonging to his/her team and establish and maintain adequate standards of people management e.g. Training and personal development, communication, interface definition and processes.
• Advise, coach and develop his/her teams regarding the preparation of key deliverables within his/her area of responsibility.
• Support annual international medical budgeting process as delegated by the TA HoM.
• Supports and backs TA HoM according to individually documented delegation of responsibilities.

• MD, PhD or PharmD from an accredited institution.
• Sound clinical and scientific experience in the TA of ten to fifteen (10-15) years (combination of hospital, academic and industry experience. Clinical / pharma experience in the US a plus).
• Experience in registering products in Europe, the US and Asia.
• Expertise in medical affairs / scientific affairs, clinical development / basic research, regulatory affairs, relevant disease area.
• Solid relationships with key stakeholders.
• Sound medical and scientific leadership - maintains team's focus on high priority items even under constantly changing circumstances.
• Pragmatic leader that supports teams to remove hurdles and resolve issues.
• Ability to act with grace and resilience under pressure.
• Excellent communication, negotiation and influencing skills.
• Excellent cross-functional collaboration skills.
• Full command of English Language.
• Excellent presentation, training and facilitation skills.
• Strong track record of interactions with regulatory affairs authority, international societies and other relevant stakeholders.
• Situational Responsiveness.
• Deals with Ambiguity.
• Constantly learns and improves.
• Advanced Management and Sound Management Skills.
• Strong leadership skills.

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.
• This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click  and join us in our effort to make more health.