Associate Medical Director, Clinical Research

Sumitomo Pharma

Montpelier (VT)

On-site

USD 226,000 - 282,000

Full time

14 days+

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Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Paid time off

Paid holidays

Job summary

Sumitomo Pharma America is seeking an Associate Medical Director, Clinical Development – Oncology to lead clinical trial design, execution, and interpretation from early development through global regulatory submissions. The role requires medical leadership, regulatory insight, and strong collaboration with cross-functional teams.

The position is primarily remote with periodic on-site meetings, offering a competitive base salary and comprehensive benefits.

Qualifications

MD/DO or equivalent required; residency preferred.
Subspecialty fellowship in oncology desirable.
Experience in hematologic malignancies or solid tumors preferred.
0–3 years pharma drug development experience is required.

Responsibilities

Design and oversight of clinical trial protocols and development plans.
Provide clinical input to regulatory documents and publications.
Lead cross-functional clinical study teams and ensure data integrity.
Present data at scientific and regulatory meetings and manage investigator interactions.

Skills

Hematology expertise

Clinical development

Regulatory strategy

Leadership

Education

MD/DO or non-US equivalent

Residency completed

Subspecialty fellowship desirable

Oncology trials experience

Tools

CTMS (Clinical Trial Management System)

Job description

US-Remote

Full time

R01519

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

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
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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.

Drug Screening Requirements

Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

SMPA may use Artificial Intelligence (“AI”) as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.

At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.

Our Mission

To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide

Our Vision

For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas

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