R & D Project Leader Description: The** R&D Project Leader** is responsible for timely and professional execution of assigned drug development projects. This individual leads global multi-disciplinary teams for early and late stage development projects with responsibility for planning, steering and coordination of all nonclinical development and manufacturing activities that support preclinical and clinical development from late lead optimization through to launch, including responsibility for operative device development (e.g. inhalers, auto- injectors, and companion diagnostics) as required. This job may also include responsibility for nonclinical aspects in the development of new indications, formulations and combinations, out-licensing as well as evaluations of in- licensing opportunities. A clear and transparent communication towards senior management in English both in writing and presentations is required from the R&D Project Leader. Early stage drug development encompasses the late Research phase (lead optimization, compound profiling), the early development phase (cell line development, early process development) until and including the clinical studies where Proof of clinical principle (PoCP) is demonstrated, typically Phase II. Nonclinical development studies conducted during this time frame include animal studies investigating drug safety (toxicological animal studies), primary and secondary pharmacology as well as investigations into pharmacokinetics and metabolism in different animal species. Furthermore, the active pharmaceutical ingredient (drug substance), pharmaceutical formulations (drug product) together with respective analytical methods are developed and manufactured for utilization in animal and human studies (Phase I and II clinical trials). Also, the final drug product formulation for Phase III clinical trials and marketing is determined. In late stage drug development, scale-up activities of drug substance and drug product formulations for clinical Phase III trial supply and the market are conducted as well as development of analytical methods for quality control of drug substance and pharmaceutical product. Also, further studies to investigate nonclinical drug safety and drug metabolism and pharmacokinetics in support of clinical Phase III trials and marketing are pursued and the documentation for the market authorization application is generated and reviewed under collaboration of all nonclinical disciplines. 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: * Leadership of global Research & Development project teams for new drugs and new indications, formulation and combinations. * Steering of all nonclinical (CMC, pharmacological, toxicological, pharmacokinetic and metabolism related) development activities as well as enabling drug development activities and ensuring drug supply for clinical studies investigating safety and efficacy of drugs in humans. * Creation and maintenance of project plans (including budget information of external activities) for drug development projects, comprising all relevant nonclinical (biological and CMC), regulatory and clinical work packages and milestones. * Representation of all Research & Development aspects in international Core Teams (global development teams) for drug development. * Operational responsibility for the transfer of projects from Research to Development. This includes elaboration of nonclinical development concepts in an early Development Team (i.e. development plan with alternative scenarios, timelines, and budget information) in preparation of the milestone SoD. Contribution to IU alignment meetings with the Special Research Therapeutic Area Portfolio Committee (sRPC). * Regular, transparent and pro-active presentation of project status, project progress and critical issues at steering committees clearly assigning status, risks, challenges and project opportunities as well as preparation of committee decisions. * Coordination and assessment of scientific contributions on drug research and drug development at meetings with drug regulatory authorities under consideration of scientific expertise. * Responsible for strategic aspects of the transfer of compounds from Development to Operations or BioBU according to CMC (drug substance and drug product) development strategy. * Responsible for in-depth evaluations of the nonclinical part of licensing opportunities and for preparation of the nonclinical package for out licensing as well as preparation of proposals for new indications, formulation and combinations. * Lead of (or participation in) strategic initiatives improving and innovating the drug development process within BI. Requirements: * DoctoralDegree (PhD, MD, PharmD) with 5+ years in drug development or pharmaceuticalindustry (e.g. pharmacology, toxicology, DMPK, drug product or drug substancedevelopment, analytics, biopharmaceuticals, medicine, veterinary medicine) ORMasters degree with 7+ years in drug development or pharmaceutical industry(e.g. pharmacology, toxicology, DMPK, drug product or drug substancedevelopment, analytics, biopharmaceuticals, medicine, veterinary medicine) ORBachelors degree with 10+ years in drug development or pharmaceutical industry(e.g. pharmacology, toxicology, DMPK, drug product or drug substancedevelopment, analytics, biopharmaceuticals, medicine, veterinary medicine) * A minimum of three (3) years practical experience in one of the key areas of research or development or production is required * Years of leadership experience: 1-3 * Leadership experience: leading employees, leading projects * Generalist thinking, high degree of self-motivation, ability to focus on key aspects, solid knowledge in natural or life sciences, sense of urgency, entrepreneurial thinking, problem solving skills and ownership, commitment, and excellent communication skills. * Proven superior verbal and written communication skills and excellent presentation skills. Desired Skills, Experience and Abilities: * Prior R&D team membership from a technical discipline is desirable. _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 Our Culture: _ _ Boehringer Ingelheim is one of the worlds 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, 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. **Primary Location: **Americas-United States-CT-Ridgefield **Work Locations: ** **Job: **Research %26 Development **Organization: **Boehringer Ingelheim Pty Limited **Schedule: **Full-time