Head of Medical Affairs Rare Diseases

Basic qualifications: 

• MD (and PhD preferred) with considerable experience within R&D, (HQ and local/regional) Medical Affairs and strong business acumen
• Experience in Rare Diseases and in interactions with relevant external stakeholders (patient groups, regulators, HCPs, etc.) in Rare Diseases strongly preferred
• Demonstrated solid understanding and knowledge of late stage drug development, specialty care prelaunch/launches, core principles in how to use clinical data, guide strategic use of clinical data, and implement clinical studies. Furthermore, experienced in budgeting and forecasting.
• Proven  experience  of  interactions  with  high  level  external  experts  (physicians)  across multidisciplinary therapeutic areas - requiring a high level of medical knowledge/experience, understanding of patient management, and strong clinical judgement on benefit: risk significance.
• Demonstrated experience as a strong integrative matrix leader that is able to bring together the various strands of input from R&D, Commercial and Medical into a cohesive strategy and plan that brings benefits to patients, other stakeholders, and to the GSK business.

Preferred qualifications: 

as above

Details: 

.THE RARE DISEASES ORGANIZATION

GSK Rare Disease mission is to establish an integrated, global reach capability in rare diseases treatments, spanning from genomics through to commercialization, enabling the company to deliver more medicines of value to underserved patient populations.

GSK is striving to combine the best of both worlds – the connectedness of a small biotechnology firm and the ability to leverage its heritage and infrastructure. Our exciting portfolio of marketed and clinical stage medicines for rare diseases includes:

? a marketed portfolio in PAH (pulmonary arterial hypertension) with strong growth prospects and focus on patient support
? two development programmes in amyloidosis, a rare and fatal family of disorders: IONIS-TTRRx (GSK2998728) being developed in conjunction with Ionis Pharmaceuticals for transthyretin (TTR) amyloidosis, and  anti-SAP, a  combination of  a  small molecule and  an  anti-SAP monoclonal antibody that is applicable for all forms of systemic amyloidosis
? As part of the Gene Therapy group - ex-vivo gene therapy being developed in conjunction with TIGET/Ospedale San Raffaele (OSR) in Milan, initially for ultra-orphan monogenic diseases such  as  ADA-SCID (adenosine deaminase severe  combined  immune  deficiency), WAS (Wiskott Aldrich Syndrome), MLD (Metachromatic Leukodystrophy), followed by Beta thalassaemia and other applications. Strimvelis gene therapy for ADA-SCID was approved in May 2016 via an MAA that supports patient access at the single site in Milan

This is a unique opportunity to take part in the journey to become a worldwide leader in the rare diseases field, whilst impacting the development of transformational new medicines. 



THE POSITION

The Head of Medical Affairs, Rare Diseases will be entrusted with ensuring that GSK optimizes the medical opportunity from each product in the pipeline, drives optimal strategic medical approaches to commercialization and business growth through all of GSK’s major markets, and builds a healthy and growing franchise.   The Head of Medical Affairs will have overall medical affairs accountability for all assets in the portfolio of the Rare Disease Unit, including driving the integrated evidence strategies and plans for the portfolio in collaboration with R&D. The Med Leader will be driving multiple senior collaborations internally as well as partnering closely with external experts and other external stakeholders.   This medical leader role will report directly to Head of R&D & Medical, Rare Diseases Unit.

The main responsibilities of the role will include the following:

• Develops Rare Disease medical affairs strategy and provides medical strategic leadership in pre-launch, launch, and life cycle management activities
• Owns the medical affairs accountability for the full portfolio and tracks medical affairs metrics and performance for the Rare Disease Business Unit
• Oversees medical affairs governance and works across the entire Rare Disease Business Unit, including connections with Regional Medical Leaders
• Provides medical insights, integrated evidence strategy & plans, and medical stakeholder communications
• Represents the medical voice of Rare Disease Franchise into R&D
• Reviews and approves the asset evidence plans
• Coordinates Rare Disease Global Medical Asset Leads + RDU Area Medical Leaders, RDU Patient Advocacy, and Medical Strategy & Operations

The ideal candidate will have extensive pharmaceutical industry experience in medical affairs leadership roles and clinical research experience which incorporates responsibility for clinical development programs or the like. In addition, a demonstrated track record of successful working relationships and interfaces with commercial & R&D organizations, and other cross-functional teams, ideally at global and regional levels and in multiple geographies. In particular, tightly integrated collaboration and aligned strategies for e.g. gene therapy development and Medical affairs must be secured for the continued successful advancement of this highly specialized field of novel medicines. 
You will have a strong understanding of managing and applying medical governance principles across complex processes and activities, along with prior pre-launch/launch experience.

A passion for Rare Diseases and extensive experience in interactions with relevant external stakeholders (patient groups, regulators, HCPs, etc.) in Rare Diseases is strongly preferred.

You will be expected to have robust collaboration qualities demonstrated by a track record of managing large, multi-functional teams over which you have no hierarchical authority, preferably in international settings. In addition you should have proven leadership and direct managerial capabilities, including the ability to engage, attract and retain talent. Self-confident, independent, and self-motivated, you should bring a superior performance orientation and a highly operational mind set with the ability to lead decisively.
With a mature and wise personality, you will have sufficient stature to interact with the most senior executives at GSK.   You will bring a high energy level and deep medical scientific integrity and the ability to manage challenges constructively, while defending your opinions as needed, always keeping the interests of the patients and therefore, the company, in mind. 


CORE COMPETENCE PROFILE
The ideal candidate will demonstrate the following competencies:

• The ability to influence both externally and inside the company: able to build and maintain effective relationships with a wide range of international and diverse stakeholders; talented in managing both internal and external relationships and working effectively in matrix structures across functions and geographies, building consensus even in tight situations; possess a natural inclination for teamwork and an ability to constructively contribute to discussions beyond one’s strict scope of responsibility.

• Can think strategically and identify key priorities: aware of the overall medical issues facing the business in a broad range of topics, markets and cultures; using superior analytical skills and an ability to develop proactive plans to address opportunities or overcome challenges; be capable of spotting previously unidentified medical and business opportunities and contributing to shaping the company’s strategy beyond own functional area.

• Track record of driving results: able to instil a sense of pace and urgency into the business; be a self-starter and a self-motivated individual who moves quickly and decisively in all circumstances; be able to track performance against measurable metrics with strict observance for quality and compliance; possess a strong inclination towards continuous improvement and questioning status quo; be able to always keep the company’s performance in focus.

• Team  Leadership:  as  indicated  by  a  track  record  of  effectively  leading  substantial, performance-focused teams, and being collectively accountable for meeting agreed objectives without necessarily having direct hierarchical responsibility over them; be able to relate to all levels of the organization and stay constantly in touch with relevant developments; be able to manage by influence rather than authority; be experienced with building on existing excellence and attracting talent to projects wherever and whenever needed.


Please use your cover letter to highlight how you meet the competencies required for the role. Your cover letter along with your CV will be used to assess your application.

The role will be located at Brentford, near London, in the UK.

Contact information: 

You may apply for this position online by selecting the Apply now button.