Apply on Employer Site

AstraZeneca · 2 weeks ago

Global Clinical Program Lead, Radioconjugate Late Development Oncology

Waltham, MA

Full-time

Onsite

Senior Level

7+ years exp

AstraZeneca is a pioneering company dedicated to transforming cancer treatment through innovative approaches. As a Global Clinical Program Lead, you will manage late development oncology clinical programs, ensuring strategic oversight, mentoring team members, and collaborating effectively with various stakeholders to drive clinical study success.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Overall clinical and scientific content for the radioconjugate product or indication(s) aligned to GPT strategy

Sets team vision and goals aligned to TALT and product strategy

With the DCD, ensure the CPT rapidly implements new processes, systems, and learning

Prioritization of clinical activities within the clinical program and ensures forward-looking risk mitigation strategies

Promotes cross-functional, proactive, and solutions-oriented team actions through end-to-end knowledge of oncology drug development

Enables quick and effective troubleshooting within the CPT and its associated sub-teams

Mentors individual team members as needed, building future AZ talent through the matrix team model

Single point accountable leader for the design, delivery, and interpretation of clinical studies ensuring ethical and scientific integrity

Accountable for late phase study designs and study design concept delivery within their assigned oncology program of studies

Provides strategic clinical and scientific knowledge to Study Physicians for initiation, execution, and completion of clinical studies

Represents the company and delivers clinical information/answers to Regulators, Ethic Committees, Marketing Companies, investigators/sites

Provides strategic clinical and scientific knowledge into development decision points/TPP/TPC and target labeling

Works as a delegate of the Global Clinical Head across several oncology studies

Can be the clinical representative on Global Product Teams for the assigned part of the program

Ability to form and maintain an excellent reputation outside of AZ

Trial conduct and hands-on delivery accountabilities

Accountable to GCH or delegate for significant clinical aspects and design/delivery of studies

Collaborates seamlessly with global colleagues at other R&D sites

May be accountable for identifying risks and proposing mitigation strategies for successful Phase II, III or IV studies

Maintains up-to-date knowledge of relevant scientific literature

Delivers analyses of clinical data in a balanced and statistically robust manner

Significant role in shaping the function through idea generation and leading improvement projects

Seen as a role model in their function, providing hands-on coaching and mentoring to staff

Qualification

Oncology clinical developmentClinical study designBiostatistics knowledgeLife Science degreeCross-functional teamworkStrategic influenceRegulatory knowledgePresentation skillsMentoring skillsCollaboration skills

Required

Life Science-based degree at masters or above (i.e. M.D., PHD, PharmD, Masters in Life Science-based area)

7+ years clinical research expertise in oncology clinical development including study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results

Strong knowledge and understanding of the Oncology therapeutic area with experience in diverse biological mechanisms

Proven track record of successful clinical delivery with demonstrated examples of strategic influence to clinical studies/programs

Explores positions and alternatives to reach agreements and solutions. Presents clear arguments to gain acceptance of ideas and influences outcomes to meet organizational objectives

Good knowledge of biostatistics, Clinical Development, global regulatory environment and pharmacovigilance and working knowledge of medical affairs and payer environment

Proven cross-functional teamwork and collaboration skills

Excellent presentation skills. Can communicate effectively with internal and external collaborators

Preferred

MD & PhD (or other complementary degree) in scientific discipline

Experience in radioconjugate clinical development programs

Late phase development experience preferred, especially within prostate cancer indications

Strong general medical knowledge

An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and factors influencing drug development

An understanding of the interplay between clinical, commercial objectives, drug safety, and regulatory requirements

Demonstrated ability to lead, coach, and mentor junior physicians/scientists

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)