Associate Medical Director, Clinical Research

Job Overview

We are currently seeking a dynamic, highly motivated individual for the position of Associate Medical Director, Clinical Development - Oncology. This individual will develop, plan, execute, and interpret clinical trial activities of novel compounds, in various indications through early development to global regulatory submissions. This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.

Job Duties and Responsibilities

• Demonstrate ownership of the design and implementation of a clinical protocol that supports the product development plan, based on strong medical and scientific principles. An emphasis on hematological malignancies is preferred
• Provide clinical and medical input to protocols, regulatory documents, publications, and site/investigator interactions especially in complex patient cases
• Respond to site questions related to eligibility, concomitant medication assessments, dose modification guidance, and provide investigator medical support
• Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data
• Conduct study support, data review and query of sites, and provide scientific leadership with clinical research scientists
• Present at scientific, medical, and regulatory meetings globally
• Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOLs, and patient advocacy groups
• Contribute to company's planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents
• Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing
• the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders
• Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
• Maintain ethical standards of the highest level and have the knowledge and ability to
• undefined
• As required by program needs, contribute to partnership with Discovery colleagues to the design and implementation of translational strategies
• Participate in meetings and committees of parent company or other affiliates.
• Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates.
• Work in close collaboration with the late-stage development group

• Perform other duties as requested.

Key Core Competencies

• Ability to run a complex clinical research program with some direction
• Extensive knowledge of hematological malignancies is preferred
• 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
• Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive
• Able to lead through influence
• Excellent communication and presentation skills are essential.
• Identify the key competencies or attributes required to excel in the role.
• Examples may include problem-solving, teamwork, communication, etc.
• Highlight any specific qualities or traits that are important for success in the role.
• These could include attention to detail, adaptability, creativity, etc.

Education and Experience

• Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD
  • Completion of a residency program strongly preferred
  • Completion of a subspecialty fellowship is desirable
  • Experience in blood cancers or solid tumors desirable
• 0 to 3 years of pharmaceutical drug development experience required.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

$225,500.00 - $281,900.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.