Director, ILD, Clinical Development & Medical Affairs Specialty - #337782

Boehringer Ingelheim


Date: 07/22/2021 18:00 PM

City: Roxbury, Connecticut

Contract type: Full Time

Work schedule: Full Day

Role serves as an established, internal scientific/medical expert for therapeutic area, contributing to US product strategy in collaboration with other functions that drive product commercialization. This role is also a strong partner and influencer of the global product strategy.

Contributes to and oversees the execution of this strategy across BI primarily through the development of the product strategy and the translation of this product strategy into a highly impactful US medical plan with the goal to medically support maximizing the number of appropriate patients receiving BI’s medications.

Provides expert medical/scientific advice and guidance to support the needs of internal partners for designated therapeutic area (e.g., Marketing, Public Relations, Strategic Engagement, Patient Advocacy, Clinical Operations, Medical Information, Grants, Field Based Medicine, Legal, Compliance, Regulatory, Corporate etc.). Supports therapeutic area strategy and planning through working with external parties and internal leaders. Continually seeks to increase market awareness and expertise by developing relationships with outside organizations/experts to support research programs, clinical development programs, licensed product maintenance and optimization and life cycle management. This includes, but not limited to, supporting the strategy for local Medical Advisory Board and Expert Panel meetings, Medical Grants, External Collaborative Research, Real World Evidence, and Medical Publications. Key member of therapeutic area leadership team.


As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.


Duties & Responsibilities:


  • Expertise
  • Possesses deep therapeutic area/scientific knowledge and in-depth knowledge of medical affairs and clinical development. Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside experts aligned with the scientific objectives and business objectives of the Therapeutic Area Section. Serves as a liaison by representing the company with key external stakeholders including Healthcare Providers, Payors, Professional Organizations and Patient Advocacy Groups. Works to understand the evolving healthcare environment (provider/expert) and payor landscapes and help to translate that working knowledge into a plan.
  • As a therapeutic area expert, incumbent may author/review/approve content used for publications and promotions. Contributes to therapeutic area grant strategy and participates in internal and external events/forums to advance BI's US business.
  • Interface/Collaboration (e.g. Commercial, Clinical Operations, Statistics, Pharmacovigilance, Regulatory, Compliance, Legal, Field Based Medicine, Public Relations, Strategic Engagement, Professional Advocacy, etc.)
  • Provides medical/scientific advice by working closely with local functions on the full clinical trial life cycle. Reviews, synthesizes, and analyses clinical trial data and translates data into actionable plans at the product level. Collaborates with teams on US feasibility assessments and provides feedback to the Global team to guide protocol development. Contributes to the development of the clinical trial protocol and associated documents.
  • Medical Action Strategy and Planning
  • Provides input into the therapeutic area strategy including participation in the Integrated Brand Planning.
  • Leads development and implementation of the annual therapeutic or indication section of the medical tactical plan and/or annual operating plan. Develops product strategy for local Medical Advisory Board and Expert Panel meetings, Medical Grants, and Medical Publications
  • Charged with determining the scientific objectives and ensuring creation of content for field-based medicine (Medical Science Liaisons/Account Medical Advisors) ensuring staff are adequately trained and informed of US BI data and TA strategy
  • Collaborates with Scientific Communications, Field Based Medicine, Clinical Operations, and Regulatory leaders ensuring BI US is collecting the appropriate information/data, monitoring, analyzing and translating this data into an actionable plan with measurable objectives
  • Provides strategic direction and scientific support for developing standard response letters and responding to HCP inquiries. Develops local investigator initiated studies, external collaborative research, and real world evidence generation objectives and serves as a member of the review team evaluating submitted proposals
  • Contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and Annual NDA and IND Report submissions
  • Participates in Medical-Legal-Regulatory review of promotional materials, rapid responses, and Guideline comment opportunities.
  • Business Acumen
  • Strong results orientation and accountability for impact of medical activities in support of therapeutic area/products, including project level budget and planning responsibilities. Highly collaborative with other business functions (e.g., Marketing, Market Access, Health Economics Outcomes Research, Public Relations, Strategic Engagement, Patient Advocacy, Clinical Operations, Medical Information, Grants, Field Based Medicine, Legal, Compliance, Regulatory, Corporate etc.). Accountability, agility, and intrapreneurship are fundamental behaviors.



Requirements:


  • Masters degree in a medical/scientific discipline from an accredited institution required
  • Doctoral degree (e.g. PhD, MD, DO) or doctoral degree in pharmacy preferred
  • Eight-plus (8+) years of experience in clinical and/or academic practice or six-plus (6+) years industry experience in clinical development or medical affairs.
  • Planning and executing Medical Affairs and/or Clinical Development strategy, clinical trials, regulatory submissions and a demonstrated ability to collaborate across non-medical functions (e.g., Marketing, Market Access, HEOR, Legal, Compliance, Regulatory, etc.).
  • Ability to effectively work independently and in a multidisciplinary team
  • Demonstrated business acumen with ability to balance need for maintaining high scientific standards with business relevance and impact
  • Demonstrated ability to establish strong customer relationships
  • Knowledge of healthcare and regulatory environment.
  • Experience leading projects and ability to motivate/lead others.
  • Requires medical or scientific training plus pharmaceutical industry experience in clinical drug development and/or Medical Affairs in the specific therapeutic area or closely related field.
  • Ability to gather and analyze insights internally and externally in order to make specific recommendations and provide solutions.
  • Knowledge of customers and healthcare systems; ability to translate knowledge and insights into actions.
  • Strong communication and collaborative skills to drive therapeutic area strategy.
  • Strategic thinking and agility to respond to market events.
  • Strong analytical, oral and written communication skills
  • Excellent time management skills and be able to work well under pressure
  • Demonstrates high ethical and profession standards with all internal and external working relationships.
  • Accountability, agility, and innovative thinking.



Eligibility Requirements:

  • 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.



Who We Are:


At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.


Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.


Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.


Job - Medicine / Regulatory Affairs
Primary Location - Americas-US-CT-Ridgefield
Organization - US-BI Pharma/BI USA
Schedule - Full-time

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