Therapy Area Lead, Nephrology, UK

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care

About This Job

The Therapy Area Lead will provide strategic Medical Affairs Leadership overseeing all MA activities / deliverables for the Therapy Area, including final Medical Signatory for the Astellas approval process.  In addition to leadership by developing and maintaining integrated partnership with stakeholders, ensuring that all MA deliverables address local business needs to bring value to patients and advance the medical/scientific understanding of Astellas products to help ensure safe and appropriate use across their lifecycle.

Specifically, you will be responsible for:

• This role is a Medical Final Signatory and the incumbent is required, subject to qualifying training, to sign the separate document entitled “APL Key Accountabilities” for Medical Final Signatory.  It outlines detailed responsibilities for a Medical Final Signatory.
• Act with integrity and be an ambassador for Astellas with internal colleagues and external experts and regulatory bodies.
• Ensure medical input to the therapeutic area brand teams including the planning, preparation and approval of: internal and external scientific product presentations, publication plan development, implementation and scientific materials, and external meetings, advisory boards and symposia.
• Ensuring that the therapeutic area objectives are realised with compliance within the Local Code of Practice, Local regulations law and sign off all applicable materials and activities including publications as compliant with the Code, Local Law and Astellas Policies/SOPs.
• Ensure all sign off processes are efficient and timely and well communicated with the Medical, Marketing and Sales Departments.
• Chair internal and external meetings as required.
• Provides strategic leadership and direction across all functions of the TA MA department to ensure all TA MA activities/deliverables are based on scientific validity, clinical importance, fiscal feasibility and aligned to both the Core Medical Plans and local business needs.
• Strategically leveraging regional and/or global medical initiatives to meet local business needs, while maintaining an enterprise view.
• Maintaining and communicating up-to-date knowledge of industry standards and practices, keeps abreast and proactively responds to market trends and/or shifts in the external medical affairs environment to predict and maximize positive impact to Astellas.
• Inspiring the Therapy Area MA department, gains commitment to the MA value narrative and motivates them to consistently deliver a standard of excellence and superior results.
• Seek and identifies relevant trends in external stakeholders’ insights to shape Therapy Area MA strategies, deliverables and execution.
• Maintain up-to-date knowledge of the therapy area through attendance at congresses, external and internal meetings and self-directed study in order to understand and be able to leverage strategic opportunities. And supports the training and compliance of MA staff to ensure therapy area expertise, integrity and to optimize performance, efficiency and quality.
• Line management responsibilities to include the proactive approach to attracting, hiring, developing and retaining a high-performing TA MA department. Supports growth and development experiences that prepares the department for broader responsibilities and creates initiatives to ensure the retention of strong performers.
• Ensure that an appropriate and stretching Personal Development Plan is in place for all direct reports and provide timely, evidence based and constructive feedback.  Ensure performance is regularly appraised, including conducting annual performance appraisal reviews.
• Provides coaching and timely feedback to ensure a productive, professional and motivated team and a highly valued work environment.
• Foster a culture of innovation, teamwork and accountability with the Medical affairs department to ensure commitment to MA excellence.
• To deputize for the Head of Medical Affairs when required

Essential Knowledge & Experience

• Medical Doctor with significant scientific/medical experience in research-based pharmaceutical industry in the areas of Medical Affairs and/or Medical Affairs & Development.
• Experience of working in a leadership capacity
• Strong knowledge of local Regulatory/Payer/HTA bodies, ICH GCP guidelines, Industry regulations, and quality standards.
• Proven team management skills, including global and/or regional and/or local matrix leadership.
• Financial and budgetary expertise.
• Strong scientific analytical and problem-solving skills, strategic capabilities, project management, planning and organization skills with excellent communication, writing and presentation skills.
• Experience with medical information IT retrieval systems; Proven ability to utilise medical/ scientific knowledge
• Project management capability. Track-record of leading planning process with excellent organisational and collaboration skills.
• Ability to proactively grasp complex sets of information and act/plan accordingly
• Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
• Demonstrable examples of ability to develop, coach and enable high performance teams and proactively promote best practice and knowledge sharing.
• Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders. 
   

Preferred Knowledge & Experience

• Specialist qualification in the Nephrology therapeutic area

Educations/Qualifications

• Doctor of Medicine (M.D)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.