This agile and accountable individual serves as an internal scientific/medical expert on the immunology team (rheumatology, dermatology, gastroenterology) where he/she will contribute to the US product strategy in collaboration with other functions that drive product development and commercialization. The Director is also a strong partner and influencer of the broader global strategy. Once the strategy is established the Director will drive tactics which supplements clinicians’ confidence and maximizes the number of appropriate patients receiving BI’s medications. As a member of the US Clinical Development and Medical Affairs organization he/she will make a positive impact on patients’ lives by advancing scientific and medical understanding.
The Director will provide expert medical/scientific advice and guidance to support the needs of non-medical internal partners within the Immunology Therapeutic Area (e.g., clinical operations, marketing, Field Based Medicine, Compliance, etc.). He/She supports the Immunology strategy and planning through collaboration with external parties and internal leaders. He/She continually seeks to increase market awareness and expertise by fostering relationships with outside organizations/experts to support research programs, clinical development programs and licensed product maintenance and optimization. This includes leading local Medical Advisory Board and Expert Panel meetings, Medical Grants, External Collaborative Research and Medical Publications.
- Possesses deep therapeutic area/scientific knowledge and in-depth knowledge of medical affairs and clinical development within the Immulogy Therapeutic Area. 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 Immunology Therapeutic Area. Represents the company with outside groups. Works to understand the evolving healthcare environment (provider/expert) and payer landscapes and translates that working knowledge into a plan.
- As the Immunology expert, the incumbent may author/review/approve content used for publications and promotions. He/She contributes to Immunology grant strategy and participates in internal and external events/forums to advance BI's US business.
- 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.
- Leads development and implementation of the annual Immunology Medical Tactical Plan. Develops product strategy for local Medical Advisory Board and Expert Panel meetings, Medical Grants, and Medical Publications.
- Determines the scientific objectives and ensures creation of content for field-based medicine (MSLs/AMAs) ensuring staff are appropriately trained and informed of US BI data and the 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 responses to HCP inquiries. Develops local IIS research objectives and serves as a member of the IIS 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.
- Strong results orientation and accountability for impact of medical activities in support of TA/products, including project level budget and planning responsibilities. Highly collaborative with other business functions (e.g. Marketing, HEOR).
- Doctoral degree from an accredited institution (e.g. PhD, MD, and DO) or Doctoral degree in Pharmacy required
- Boarded Gastroenterologist, Rheumatologist, Dermatologists preferred
- Extensive industry experience in clinical drug development and US medical affairs preferred
- MD or DO with six plus (6+) years OR PhD with eight plus (8+) years OR PharmD with ten plus (10+) years industry experience preferred
- Clear record of successfully planning and executing Medical Affairs and/or Clinical Development strategy, clinical trials, regulatory submissions and a demonstrated ability to function at a program level preferred
- Experience in an Academic Medical environment with an established record of clinical investigation
- Ability to work effectively in a multidisciplinary team.
- Exhibits flexibility in working collaboratively across internal and external stakeholders
- Demonstrated business acumen with ability to balance need for maintaining high scientific standards with business relevance and impact
- Excellent communication skills
- Demonstrated ability to establish strong customer relationships
- Focus on external customers
- 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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.