Product Medical Lead

5 days left

Employer
Location
Cambridge, MA, USA
Salary
Competitive
Posted
Nov 17, 2018
Closes
Dec 17, 2018
Ref
885458029
Discipline
Medicine, Medical
Contract Type
Full Time
Job Type
Other job types
**Responsibilities**

% of Time

**20%**

**Support development of US medical strategy and plans with alignment with Global Medical Team**

+ Work with GMTL and Global Franchise and Product Leads to develop US medical plans that include tactics to support key strategic imperatives for the disease area / brand(s) in both pre- and post- launch setting.

+ Support development of the in-year medical tactical plan and budget for US initiatives and where applicable, collaborate with Global initiatives

+ As delegated by the GMTL functional (e.g. publications, medical communications, medical information and medical training) plans supporting US medical strategy with alignment with Global where applicable.

+ As delegated by the GMTL, collaborate with relevant business partners to ensure aligned and medically appropriate brand strategy, planning and execution

+ As delegated by US,GMTL, participate in product development strategy and provide medical affairs and R&D inputs

**40**

**Implementation in-year of US medical strategy with global alignment**

As delegated by the GMTL and IMM Franchise Head, directly implement plans in the US and collaborate with Global Franchise and Product Leads, potentially including:

+ Development and implementation of medical pre- and post- launch plans for late-stage pipeline products or product label expansions for US

+ Providing medical leadership for scientific communications, including core scientific statements, standard responses, Phase IV plans, and publications

+ Planning, designing and managing or participating in local, regional, national and global medical Advisory Boards including working with vendor(s) to ensure timely submission and approval in RnD select

+ Providing medical review of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process as designated GMTL

+ Managing design and execution of clinical studies (phase IIIb/IV, disease registries, HEOR studies, outcomes surveys, etc.) in close collaboration with Global Franchise and Product Leads, Scientific Affairs, Shared Medical Excellence and Clinical Operations

+ Managing completion of regulatory obligations (e.g. medical affairs input in safety review teams (SRTs).

+ Monitoring and communicating progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements

+ Conducting and ensuring timely medical review and approval of promotional and meeting materials as required per SOP

+ Serving as US Medical representative on standing and project-based cross-functional teams Serving as Global Medical representative on standing and project-based cross-functional teams

**30**

**Effective compliant collaborations with internal stakeholders (R&D, commercial, marketing, regulatory, legal, and compliance) and scientific exchanges with external stakeholders (KOLs and HCPs) in alignment with customer needs and medical strategy**

+ Act as a company medical representative to engage external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities

+ Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders

+ Per medical strategy, establish appropriate partnerships with KOLs in areas of scientific interest.

+ Represent Medical Affairs at internal and external meetings

+ Present data on product / disease area at internal and external meetings

**10**

Maintenance of knowledge base

+ Serve as a key medical resource on the disease area and on specific product

+ Maintain a high level of expertise on the disease area

+ Develop and maintain knowledge of US and International pharmaceutical regulations, guidelines codes of practices and Shire policies related to all medical activities

+ As directed by the GMTL and Global Franchise,, Product Leads will develop, conduct, or participate in therapeutic training programs for Shire internal department

**Education and Experience Requirements**

+ A Doctor Degree in Medicine (MD), PhD, or PharmD is required.

+ At least 5 years of related work experience in industry, clinical or research institution, preferably in genetics, metabolic, pulmonary, hematology or AATD related experiences

+ Experience in medical affairs particularly rare disease is preferred

+ Experience in supporting brands or disease area levels in country, regional or global organizations is preferred

+ Experience in other relevant disease areas of interest through clinical experience, biopharmaceutical experience or education may be considered

**Other Job Requirements**

+ Availability to travel domestically and internationally as needed for approximately 20-30% of time

+ Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends

**_Notice to Employment / Recruitment Agents:_**

_Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire's Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration._

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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EEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.