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Director Clinical Development

5 ore fa

Milano, Lombardia, Italia Sobi - Swedish Orphan Biovitrum AB (publ) A tempo pieno

*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 in 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.

This position will require representing Sobi clinical development strategy externally as well as in internal meetings with senior management if required.

Essential to success is a
strong clinical development background with previous experience in late stage clinical trial design and conduct and in major regulatory submission (e.g. EU, Canada, Japan); excellent medical knowledge in lipidology and cardiovascular
, ability to build and maintain strong relationships with study investigators / key opinion leaders (KOLs), and ability to collaborate crossfunctionally.

*Job Description*
Including, but not limited to the following:

  • 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 stratetgy 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.

Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.

*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.