(Senior) Director Clinical Development

Company Description The (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product.

Specific responsibilities include: design of clinical trials (any phase as required by the clinical development program, including phase IV), clinical protocol development, medical monitoring of clinical trials, analysis of study data, contribution and review of clinical study reports, of clinical modules of registration dossiers, of briefing books for interactions with Health Authorities.

The (senior) Director Clinical Development will represent and defend the clinical strategy during the MAA regulatory review process across multiple geographies and in meetings with Health Authorities.

The individual will closely work with other RD functions to ensure the successful progress of projects and clinical trials and will interact with the scientific and patient community to ensure their insights are adequately incorporated in the clinical trials.

Responsibilities

Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standards

Design, conduct and report Sobi-sponsored studies in close collaboration with the rest of the clinical development team, the clinical study teams, regulatory, safety and other cross-functional teams, as applicable

Act as Study Physician responsible for Sobi-sponsored studies if required: responsible for the development of clinical study synopsis and protocols, contribute to the statistical analysis plans, perform medical monitoring, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriate

Interact and consult with key opinion leaders and patient representatives, and lead advisory boards to define the clinical development strategy and inform the clinical trial design

Provide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authorities

Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority’s questions to support e.g., scientific advice, IND application, marketing authorization across multiple geographies

Represent the clinical function in meetings with Health Authorities

Qualifications Experience/Competencies (Required)

Medical Degree

Specialty in cardiology, lipidology, endocrinology or relevant previous clinical development experience (+7 years) in these therapeutic areas

Relevant global clinical development experience in the Pharmaceutical Industry (+10 years)

Previous experience in interactions with major Health Authorities

Solid record of accomplishment in drug development programs within the relevant therapeutic area demonstrating outstanding and intimate understanding of translating early stage programs into the clinic and further across the clinical development chain

Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making

Demonstrated ability to build and execute strategic and tactical development and medical plans

Experience and ability to engage with key internal and external stakeholders

Highly Desired

At least 5 years clinical experience in treating patients

Successful interactions with major Health Authorities leading to drug approvals

Skills/Languages (Required)

Excellent communication skills, capable of representing the company to all audiences both internally and externally

Strategic mindset

Excellent organizational skills, be a self‑motivated driver of best practices and processes in the management of projects and operations

Excellent written and verbal communication skills in English

Able to demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership

Personal Attributes (Required)

Good team‑player, able to work effectively in a team setting and interact respectfully with people of different cultural, seniority and functional backgrounds

Highly flexible and comfortable working in a fast paced and quickly changing environment

Able to work well in a virtual environment. Proven self‑management by showing initiative, good organization and willingness to be held accountable

Results oriented with a can‑do and proactive attitude

High medical, scientific and ethical integrity

Able to prioritize

Additional Information

Driven, flexible and with strong team working and project management skills

Strong interpersonal, cultural and communication skills

Analytical, with a problem‑solving and collaborative mindset

Forward looking mindset, to ensure that our PV ESP systems and operations environment is being continuously developed to ensure ongoing compliance and to deliver high quality and cost effective outcomes

Strong ability to work independently and to make priorities in order to deliver business critical items in time

Demonstrate the Sobi Values: Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership

Seniority level Director

Employment type Full‑time

Job function Science

Industries Pharmaceutical Manufacturing

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