Director, Pharmaceutical Development

Job description

AbbVie Process Chemistry is responsible for the chemical development of AbbVie’s clinical candidates. We are seeking a Director, Pharmaeceutical Development to lead the Radiochemistry team that is responsible for labeling experimental drug candidates from preclinical through clinical development. We are looking for a highly motivated person who can drive the development of drug candidates from early discovery to late-stage development through radiolabeling. The candidate will lead a group of scientists in the labeling of materials with tritium and 14C. The candidate will serve as the primary contact for labeling requests and as such would be responsible for developing strategies, timelines, and key activities required for radiolabeled drug substances. The candidate must be able to mentor and develop staff with experimental approaches to solve difficult scientific and technical challenges. Working with discovery, drug metabolism, analytical and chemistry colleagues, the candidate will develop productive collaborations and effectively communicate with scientific teams. Responsibilities: The candidate will lead activities associated with labeling and characterization for new drug substances. Lead the design and execution of labeling strategies. Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor staff in troubleshooting strategic and experimental issues. Author and review key regulatory documents, laboratory data, technical memos, standard operating procedures, and reports. Collaborate to ensure successful CMC interactions with regulatory authorities. The position involves multi-disciplinary interactions with organic chemists, analytical chemists, engineers, drug metabolism scientists, formulators, and program management. The candidate will utilize his/her expertise across disciplines to advance the pipeline. The candidate will encourage ideas for continuous improvement activities and initiatives within the Radiochemistry team. The candidate will understand, adhere, and ensure compliance with corporate standards regarding code of conduct, safety, radiosafety and GXP compliance. Lead the development of innovative radiolabeling synthetic methods, to solve critical technical problems and advance the portfolio. Utilize expertise, portfolio awareness, and cross-functional network to identify new opportunities for radiochemical studies. Design, with cross-functional partners, innovative radiochemical experiments to answer critical scientific questions and advance the portfolio. Provide strategic and technical leadership in evaluating and advancing candidates across modalities. Provide strategic and technical leadership at the interface of synthetic chemistry, formulation development, imaging capabilities, and DMPK, to enhance understanding of assets across the AbbVie portfolio. Qualifications: BS (20+ years); MS (18+ years) or PhD (12+ years) in Chemistry or allied field, with 8+ years of previous work experience in a pharmaceutical laboratory setting. Experience in radiolabeling and safety. Experience in managing and developing scientific leaders is required. The successful candidate will have a strong understanding of synthetic organic chemistry, process development, GXP compliant processes, and radiolabeling strategies to appropriately label compounds to meet the study needs. Key AbbVie Competencies: Interacts well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance. Learns fast, grasps the "essence" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.