Reports to: Senior Vice-President, Clinical Development/Chief Medical Officer
Job Code: 2018-70-10
The Vice-President, Clinical Development provides strategic leadership for all clinical aspects of development. The Vice-President, Clinical Development also represents clinical and medical functions to company management, and plays a lead medical role in multiple external settings including interactions with investigators, health authorities, conferences, and in public presentations. Works closely and collaboratively with other functional areas.
- Develops and implements overall clinical strategy for company programs, including assessment of best fit for mechanism of action with unmet medical need, optimal clinical trial strategy, and competitive landscape
- Drives the implementation of the clinical program through hands-on leadership of the clinical and medical functions within Development
- Provides leadership to cross-functional teams with regard to medical and drug strategy for product development, efficient clinical program design, risk mitigation, and key decisions to support program success
- Cultivates and maintains relationships with the highest level national and international investigators to achieve broad visibility and support for the company’s programs. Interacts with key opinion leaders to assure incorporation of the latest advances in clinical and treatment guidelines into the clinical plan.
- Leads the clinical aspects of development, including the conceptualization, design, strategic planning, implementation, medical leadership and oversight of clinical programs for all phases of development. Identifies opportunities for innovative design or clinical strategies to accelerate trial progress in areas of unmet need.
- Combines a thorough understanding of clinical research science and methods with a broad understanding of team dynamics to motivate and lead the Clinical, Medical, and Pharmacovigilance teams in successful execution of the clinical programs
- Oversees and leads the planning and implementation of clinical trial analysis and interpretation in the context of the current medical climate, reporting of clinical data to regulatory agencies, and public presentation of clinical trial outcomes to advance the company’s goals
- Leads the clinical team to ensure all clinical protocols are of the highest quality focusing on clinical, translational, and regulatory aspects to enable optimal decision-making
- Collaborates across functional areas within research and development to ensure alignment with corporate and department objectives and to foster strong consensus for complex decision-making
- Supports Corporate Development in interactions with outside parties, including in due diligence activities as needed
- Complies with all applicable policies regarding health, safety and environmental policies
- MD or MD/PhD with board certification in the US for a field related to oncology, hematology, or immunology. Hands-on patient-care experience strongly preferred
- Must have at least fifteen  years of industry experience in clinical development with at least 8 years of experience designing and executing clinical trials in one or more of these same areas. Phase 3 experience preferred
- Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
- Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US and EU. Very strong knowledge base of FDA regulations and ICH and GCP guidelines
- Significant experience in communicating and presenting complex information to various audiences- both internal and external
- Demonstrated experience with project planning and exceptional problem-solving
- Strong negotiation skills capable of influencing senior leaders both internally and externally
- Strong leadership profile with executive presence and business acumen.
- Highly collaborative; flexible in personal interactions at all levels of the company
- Outstanding presentation, written and oral communication skills
- Ability to travel approximately 20% (domestic and international)
GlycoMimetics, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter to HR@glycomimetics.com and reference job number 2018-70-10 in the subject line.