Under the leadership of the Head of Clinical Pharmacology, the Director/ Senior Clinical Pharmacology Director is responsible for: Leading the Clinical Pharmacology program and strategy for defining and implementing the Early Development/Clinical Pharmacology Plan to support the registration dossier; Providing scientific and operational support to the Early Development studies (first-in-human, proof of concept) and late-phase Clinical Pharmacology studies (drug-drug interactions, special populations); Aligning plans and strategies with partner line functions and internal or external stakeholders; And interacting with Health Authorities. The Senior Clinical Pharmacology Director is accountable for the early drug development and translational strategy within the Project Team, and for the clinical study protocols and their operational implementation within the clinical Study Team.
Essential Duties & Responsibilities
Early Development/Clinical Pharmacology Strategy
- In close collaboration with internal and external key stakeholders, define the Early Development/Clinical Pharmacology Plan and registration strategy for endocrinology and women’s health compounds
- Provide input on study design for Early Development studies (first-in-human, proof of concept) as well as late-phase Clinical Pharmacology studies (drug-drug interactions, special populations),
- Contribute to the appropriate use of biomarkers in Clinical Pharmacology studies with a focus on endocrinology
- Contribute to the preparation of regulatory components Clinical Trial Applications (IND, IMPD, IB) and any other regulatory submissions (summary documents),
- Attend meetings with external stakeholders (investigators, KOLs) and Health Authorities.
Project Team Member
- Represent the Clinical Pharmacology function in Project Teams and endorse accountability for Clinical Pharmacology deliverables,
- Liaise with key partner line functions to identify potential project hurdles, provide solutions and contribute to contingency plans,
- Responsible for the timely and effective communication of strategy and results to the Project Team by efficient communication.
Clinical Study Team Member
- As a core member of the Clinical Study Team, provide guidance for the design and successful execution of Early Development and Clinical Pharmacology studies,
- Participate in the identification and the evaluation of clinical trial sites and CROs,
- Contribute to the clinical study design, author clinical study protocols and clinical study reports,
- Review and evaluate clinical study data, provide scientific input for their interpretation and adaptation of further development steps (data driven)
- Prepare and attend meetings with investigators, external experts and Health Authorities.
Scientific expertise and organizational excellence
- Contribute to the evaluation of licensing-in opportunities with a focus on endocrinology and women’s health
- Contribute to the department working standards,
- Strictly adhere to GxP guidelines, SOP and other working practices, as appropriate,
- Actively participate in internal workstreams and cross-functional or cross-departmental initiatives.
Core Competencies, Knowledge and Skill Requirements
- Working knowledge and experience with Word, PowerPoint and Excel
- Effective time management and organization skills
- Ability to multi-task under limited direction and on own initiative
- Good interpersonal, written and verbal communication skills
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- MD, and/or PhD in pharmaceutical sciences/pharmacology, or PharmD, with at least 10 years of industry experience in endocrinology or women’s health (early development translational studies and/or late phase development with a track record of Clinical Pharmacology contributions to projects or submissions). Demonstrated success in a matrix leadership role.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
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.
Equal Employment Opportunity