Associate Director Clinical Sciences - Remote Position

Puma Biotechnology; Beverly Hills (CA); Remote; USD 180,000 - 215,000; Full time

Job summary

Puma Biotechnology is seeking an Associate Director/Director of Clinical Science to lead drug projects and interact with clinical development teams and regulatory authorities. The role requires an advanced degree and significant experience in clinical development, with responsibilities including strategy development, data analysis, and regulatory submissions.

Qualifications

• Minimum of 5 years clinical development experience in the pharmaceutical or biotechnology industry.
• Knowledge of international regulations pertinent to current clinical development (e.g., ICH, FDA, EMA).
• Highly advanced oral, writing, and presentation skills.

Responsibilities

• Responsible for advising on the development and execution of the clinical development strategy.
• Review, interpret, and present clinical and non-clinical data at governance and regulatory meetings.
• Write and review Clinical Study Reports and regulatory submission components.

Skills

Clinical development plan

Protocol design

Study team management

Data review and interpretation

Clinical study report writing

Project management

Education

Advanced Clinical/Science Degree (e.g. PharmD, PhD, MSN)

Job description

Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.

Primary Objective of Position

The Associate Director/Director, Clinical Science, acts as fully independent Clinical Science lead responsible for one or multiple drug projects. This person interacts with all members of the clinical development team as well as regulatory authorities and key opinion leaders, supervises other Clinical Scientists providing support to the projects and is accountable for quality of all Clinical Science input and deliverables. Responsibilities may include some or all of the following:

Major Duties/Responsibilities

• Responsible for advising on the development and execution of the clinical development strategy

• Review, interpret, and present clinical and non-clinical data from development programs and the relevant literature at relevant governance and regulatory meetings, scientific congresses and advisory committees

• Write and review Clinical Study Reports, and clinical components of modules for the NDA, MAA and other regulatory submissions

• Represent supported projects at scientific conferences, advisory committees, and regulatory/agency meetings

• Leads interactions with investigators and cooperative groups

• Lead contact on assigned clinical development project(s)

• Other duties as assigned

Skills & Abilities

• Must be fully knowledgeable and skilled in the development and implementation of:

  • A clinical development plan

  • Protocol design and writing

  • Study team management

  • Data review and interpretation

  • Clinical study report

• Oversee the clinical management of 1 -3 drug products and programs

• Must be skilled in functional and cross-functional people and project management

• Must have experience in the development of P1 to P2 clinical studies (preferably in the oncology area)

• Must be able to develop strong written clinical positions and rationales based on relevant data and able to verbalize and explain to a broad audience

• Must be fully knowledgeable and skilled in the development and input in the writing of regulatory documents including:

• IND (investigational plans, Investigator Brochure, orphan drug applications, ect)

• NDA/sNDA (eCTD Module 2 Clinical Overview and Clinical Summaries)

• FDA Meeting Briefing Documents (Clinical, Clin Pharm, Biomarkers related content)

Education & Professional Experience

Required:

• Advanced Clinical/Science Degree (e.g. PharmD, PhD, MSN)

• Minimum of 5years clinical developmentexperience in the pharmaceutical or biotechnology industry

• Knowledge of international regulations pertinent to current clinical development (eg ICH, FDA, EMA)

Other Requirements:

• Highly advanced oral, writing and presentations skills

• Communicates internally with senior management

• Communicates externally with scientific congresses and advisory boards

Management of Staff:

• Up to 2 direct reports including an administrative team member

• Oversees the clinical team working on a given program(s)

Compensation Range

The base compensation range for this position is $180k - $215k per year, higher compensation may be available for someone with advanced skills and/or experience.

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.Travel as needed (up to 10% expected, including international travel).

Puma Biotechnology Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, status as a protected veteran, or any other characteristic protected by law.