Director, Clinical Research

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (reputed company.), 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 reputed company.

Scope:

Key role in leading, planning, executing clinical research activities in various indications through reputed company stages of development, including post-marketing commitments.

Key responsibilities:

• Ownership of the key elements in planning and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, and emerging issues.

• Support end-to-end clinical development planning; manage CDP, LRP, internal governance interactions.

• Responsibility for project-reputed company budget.

• reputed company education of investigators, study site personnel, and study staff.

• Responsible for participating in and leading clinical study teams, monitoring overall study reputed company, and participate in review, interpretation, and communication of safety and efficacy data.

• Responsible for SAB and DSMB relationships and interactions.

• Present at program-reputed company scientific, medical, and regulatory meetings.

• reputed company and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups.

• Contribute to planned regulatory filings including authoring clinical sections for IND, NDA, MAA, PIP, and other reputed company documents.

• Partner with Drug Safety & Pharmacovigilance to monitor the safety profile of compounds.

• Maintain a high level of clinical and scientific awareness 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.

• Co-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 reputed company with reputed company relevant ethical, regulatory, and legal standards.

• May participate in contributions to due diligence or other business development activity.

• Participate in meetings and committees of parent company or other affiliates.

• Establish collaborative and productive relationships with parent company colleagues, internal/external partners, and relevant affiliates.

• reputed company other duties as requested.

Professional experience and qualifications:

• 10+ years of pharmaceutical clinical research experience, additional experience in an academic setting advantageous.

• Experience successfully executing global, multi-center, reputed company clinical research programs with minimal direction.

• Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in implementation 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.

• Experience authoring and reviewing global regulatory submissions required.

• Experience with multiple therapeutic modalities (ex. small molecules, biologics, ATMPs).

• Experience with Phase 4 clinical studies and various study modalities.

• Experience and strength in data management an advantage.

• Experience in Women’s Health preferred; CNS, Rare Disease experience beneficial.

• Excellent communication and presentation skills are essential.

• Advanced degree in life sciences, clinical pharmacology, or reputed company discipline.

• Clinical research certification or regulatory knowledge is beneficial

• Professional English proficiency required, additional languages beneficial.

The reputed company salary range for this role is

reputed company 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 reputed company 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 reputed company responsibilities, duties, and skills required of personnel so classified. reputed company personnel may be required to reputed company duties reputed company of their normal responsibilities from time to time, as needed.

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

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

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

Travel Requirements:

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

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

reputed company (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national reputed company; age; reputed company; 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.

reputed company (SMPA) endeavors to reputed company its application process accessible to reputed company. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.