What are the responsibilities and job description for the Associate R & D Project Leader position at BI Pharmaceuticals, Inc.?
Boehringer Ingelheim is currently seeking an Associate R&D Project Leader to join our R&D Project Management team in Ridgefield, CT. This role is responsible for timely and professional execution of assigned drug development projects. With support and mentorship from D&D Leads and/or Unit Heads Project Management, this individual leads global multi-disciplinary teams for early 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 Proof of Clinical Principle (PoCP). Clear and transparent communication towards senior management in English both in writing and presentations is required.
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, 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 Drug & Device (R&D) R&D 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.
- Responsible for working with and learning from Senior R&D PLs as well as subject matter experts within the Research and Development organization to develop in-depth understanding of the drug development process.
- Representation of all Research & Development aspects in international Asset 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 Start of Development (SoD). Contribution to IU alignment meetings with the Special Innovation Unit Portfolio Committee (SIUPC).
- 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.
- Responsible for operational aspects according to CMC (drug substance and drug product) development strategy.
Requirements
- Doctoral Degree (PhD, MD, PharmD) from an accredited institution with three-plus (3 ) years of experience in drug development or pharmaceutical industry (e.g. pharmacology, toxicology, DMPK, drug product or drug substance development, analytics, biopharmaceuticals, medicine, veterinary medicine) OR Master’s degree from an accredited institution with five-plus (5 ) years in drug development or pharmaceutical industry (e.g. pharmacology, toxicology, DMPK, drug product or drug substance development, analytics, biopharmaceuticals, medicine, veterinary medicine) OR equivalent
- One to two (1-2) years of leadership experience: leading projects and/or teams in a matrix environment
- Associate Project leaders R&D lead and collaborate with experts from different disciplines (see interfaces) in order to efficiently lead an R&D team.
- High degree of self-motivation.
- Ability to focus on key aspects.
- Solid knowledge in natural or life sciences.
- Sense of urgency.
- Problem solving skills and ownership, commitment, and excellent communication skills.
Onsite/Flex*: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
Compensation Data
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