Head of Asset in GU, Oncology Clinical Development

About the role

The Head of Asset in GU, Oncology Clinical Development will manage clinical development programs, oversee project-related education of investigators, and lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data.

Responsibilities

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program)
• Oversees project-related education of investigators, study site personnel
• Makes decisions on safety and efficacy of the molecule
• Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists
• Chairs Clinical Strategy Team(s) and develops a rigorous, cross-functionally-aligned, vetted Clinical Development Plan
• Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area
• Acts as clinical lead and interacts with opinion leaders
• Stays abreast of professional information and technology through conferences, medical literature, and other available training
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research

Requirements

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
• Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
• At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead and manage through influence.
• Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.

Skills

• Excellent oral and written English communication skills
• Ability to exercise judgment and address complex problems and create solutions across multiple projects

Benefits

Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k).

Pay

$248,000 - $471,500 USD

Schedule

Primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.