At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Senior Director Clinical Development 

In Bayer Research & Early Development Oncology, we discover and develop the future of cancer care by focusing on targets that impact tumor-specific vulnerabilities, agnostic to biology or modality, to help us find the medicine that will bring the most value to our patients.The Early Clinical Development Group is a team of physician-scientists that translates science into patient care focusing on patient centricity, speed and urgency.

The primary responsibility of this role is to provide overall clinical scientific leadership for one or more pre-clinical or clinical assets. You will be responsible for leading the design, operational planning, execution and decision making for one or more clinical studies. In addition, you are expected to influence pre-clinical development including target identification by providing clinical/scientific guidance.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Director Clinical Development are to:

• Be responsible for the design and execution of the clinical strategy of early assets based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity;
• Lead the Global Early Clinical Development (ECD) Team, a cross functional multinational team of internal experts, from candidate selection to the design and execution of the required exploratory clinical studies and advancement to registration studies;
• Represent the ECD at the Global Project Team;
• Create and translate Target Product Profile into clinical strategy;
• Oversee protocol development;
• Enable decision-making by interpreting safety and efficacy data taking into account relevant PK/PD data working together with a cross-functional team;
• Serve as the primary clinical contact for study medical and patient safety aspects supported by Pharmacovigilance and Clinical Trial Scientist;
• May supervise employees, both directly and indirectly through a matrix structure;
• Develop high impact relationships with internal partners across research, translational science, and clinical development functions;
• Establish, lead, and manage relationships with key external stakeholders (e.g. investigators, Key Opinion Leaders, health authorities);
• Represent the team to other decision/governance meetings, senior leaders.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• M.D., M.D./PhD or equivalent degree with 5+ years of applicable experience;
• Passion and track-record for developing novel cancer drugs based on a deep understanding of therapeutic science and clinical landscape;
• Solid experience in exploratory clinical drug development as an academic investigator or within a pharmaceutical/biotech environment. This includes understanding of the scientific methods and tools used in early development studies, biomarkers, translational modeling, biostats and a good understanding of Oncology medical needs and clinical trial landscape;
• Participated in clinical oncology studies with molecular targeted or immunological therapies;
• Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics);
• Experience with health authority interactions globally;
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions;
• High energy with focus and vision; self-motivated with a high sense of urgency, proactive and solutions-oriented. Ability to develop and implement strategic growth plan;
• Strong consensus-building skills and the ability to lead multidisciplinary teams towards sound decision-making;
• Excellent communication skills, high level of comfort/success working in a matrix environment (global/multi-cultural/cross functional), including contributing daily to building trust, establishing clarity, collaboration and driving results;
• Provide subject matter expertise and mentor others;
• Networking and alliance management.

Preferred Qualifications:

• Oncology/Hematology board certification;
• Participated and led a drug development program to registration or IND filing.