Director / Senior Director, Clinical Development leader Oncology

Alpha Clinical Laboratory Inc; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Alpha Clinical Laboratory Inc. seeks a Sr. Clinical Development Leader in Boston to guide clinical deliverables for a pharmaceutical program.

You will shape development strategy, collaborate with teams across pharmacology, toxicology, operations and regulatory affairs, and manage external outsourcing to ensure timely, on-budget execution. The role requires a Doctorate (MD) preferred with oncology training and 10–15 years in clinical development, including regulatory writing and interactions with

Qualifications

• Doctorate degree MD preferred with training in oncology.
• Minimum of 10–15 years of industry experience; with a minimum of 10 years of clinical Development experience.
• Experience leading and coordinating the clinical drug development activities of at least one approved product or program.
• Experience leading cross-functional teams and handling regulatory and non-regulatory documentation.

Responsibilities

• Provide clinical leadership and strategic medical input for clinical deliverables within the project or program.
• Lead development strategy for assigned targets and collaborate across clinical pharmacology, toxicology, operations and regulatory affairs.
• Oversee outsourcing implementation including vendor/CRO selection to operationalize clinical development.
• Interact with FDA and other regulators; write and review regulatory study documents.

Skills

MD degree

Oncology training

Clinical development

Cross-functional leadership

Regulatory documentation

Education

MD preferred

Job description

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Lead the development strategy for assigned targets and works in collaboration with asset teams to provide cross functional leadership teams to colleagues in clinical pharmacology, toxicology, BMPK, clinical operations and regulatory affairs
• Develops strategies and leads implementation of clinical outsourcing including selection of vendors, CROs and other external resources needed to successfully operationalize clinical development at ****.
• Provides clinical science research expertise, especially study design and data interpretation to achieve high quality protocol development and execution.
• Develops subject matter expertise in the therapeutic areas of interest to the Company and clearly communicates, both internally and externally, the science behind **** products and pipeline.
• Leads interactions with external thought leaders and KOLs to help formulate clinical strategies and development plans to deliver the best possible outcomes for ****’s product development.
• Provides leadership experience to the running of clinical trials including identifying program risks and developing mitigation strategies to ensure clinical programs stay on-time and within budget.
• Collaborate with members of other functions in the Company (e.g., Regulatory Affairs, Medical Affairs, Pharmaceutical Development, Sales/Marketing, et ) to achieve corporate goals.
• Provides leadership in defining the development strategy for products in development (e.g., pipeline products, LCM programs, etc.), in designing studies and in the conduct and management of clinical
• Develops, authors and reviews regulatory documents (e.g., briefing documents, IND, NDA, etc.) and study-related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.) and leads the clinical team in interactions with the FDA and other regulatory
• Works with the Company’s Business Development team and other colleagues to develop in- licensing strategies and provide key review and feedback on potential product

Overview

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Lead the development strategy for assigned targets and works in collaboration with asset teams to provide cross functional leadership teams to colleagues in clinical pharmacology, toxicology, BMPK, clinical operations and regulatory affairs
• Develops strategies and leads implementation of clinical outsourcing including selection of vendors, CROs and other external resources needed to successfully operationalize clinical development at ****.
• Provides clinical science research expertise, especially study design and data interpretation to achieve high quality protocol development and execution.
• Develops subject matter expertise in the therapeutic areas of interest to the Company and clearly communicates, both internally and externally, the science behind **** products and pipeline.
• Leads interactions with external thought leaders and KOLs to help formulate clinical strategies and development plans to deliver the best possible outcomes for ****’s product development.
• Provides leadership experience to the running of clinical trials including identifying program risks and developing mitigation strategies to ensure clinical programs stay on-time and within budget.
• Collaborate with members of other functions in the Company (e.g., Regulatory Affairs, Medical Affairs, Pharmaceutical Development, Sales/Marketing, et ) to achieve corporate goals.
• Provides leadership in defining the development strategy for products in development (e.g., pipeline products, LCM programs, etc.), in designing studies and in the conduct and management of clinical
• Develops, authors and reviews regulatory documents (e.g., briefing documents, IND, NDA, etc.) and study-related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.) and leads the clinical team in interactions with the FDA and other regulatory
• Works with the Company’s Business Development team and other colleagues to develop in- licensing strategies and provide key review and feedback on potential product

SUMMARY OF KEY RESPONSIBILITIES

• Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Lead the development strategy for assigned targets and works in collaboration with asset teams to provide cross functional leadership teams to colleagues in clinical pharmacology, toxicology, BMPK, clinical operations and regulatory affairs
• Develops strategies and leads implementation of clinical outsourcing including selection of vendors, CROs and other external resources needed to successfully operationalize clinical development at ****.
• Provides clinical science research expertise, especially study design and data interpretation to achieve high quality protocol development and execution.
• Develops subject matter expertise in the therapeutic areas of interest to the Company and clearly communicates, both internally and externally, the science behind **** products and pipeline.
• Leads interactions with external thought leaders and KOLs to help formulate clinical strategies and development plans to deliver the best possible outcomes for ****’s product development.
• Provides leadership experience to the running of clinical trials including identifying program risks and developing mitigation strategies to ensure clinical programs stay on-time and within budget.
• Collaborate with members of other functions in the Company (e.g., Regulatory Affairs, Medical Affairs, Pharmaceutical Development, Sales/Marketing, et ) to achieve corporate goals.
• Provides leadership in defining the development strategy for products in development (e.g., pipeline products, LCM programs, etc.), in designing studies and in the conduct and management of clinical
• Develops, authors and reviews regulatory documents (e.g., briefing documents, IND, NDA, etc.) and study-related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.) and leads the clinical team in interactions with the FDA and other regulatory
• Works with the Company’s Business Development team and other colleagues to develop in- licensing strategies and provide key review and feedback on potential product

Required Qualifications And Skills

• Doctorate degree MD preferred with training in oncology.
• Minimum of 10-15 years of industry experience; with a minimum of 10 years of clinical Development experience
• Experience leading and coordinating the clinical drug development activities of at least one approved
• Experience leading cross-functional
• Experience writing, reviewing, and editing regulatory and non-regulatory
• Experience dealing with and solving a variety of development-stage clinical issues of broad scope and

Skills And Specifications

• Excellent teamwork and collaboration
• Effective process and project management
• Solution
• Outstanding written and verbal communication
• Expert knowledge of scientific principles and
• Ability to multi-task.

No. of Vacancies

1

Job Nature

Full-time

Experience Requirements

10

Job Location

Boston, US

Job Level

Sr. Position