Vicore Pharma is a clinical-stage pharmaceutical company focused on developing innovative medicines in severe diseases where the Angiotensin II type 2 receptor (AT2R) plays an important role.
Embedded in our approach is the determination to find solutions for conditions which have an enormous deleterious impact on patients and their families, and to transform the lives of those affected.
The company currently has four development programs: VP01 aims to develop the medicine C21 for the treatment of idiopathic pulmonary fibrosis (IPF), COVID-19 and pulmonary arterial hypertension (PAH). VP02 is a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF. VP03 includes the development of new AT2 receptor agonists (ATRAGs). VP04 develops a clinically validated digital therapeutic for IPF patients.
The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
Vicore Pharma is expanding the development pipeline and aims to strengthen the organization. On behalf of Vicore Pharma we are looking for a talented Global Medical Director to join the Medical & Safety team. The working environment is very flexible and pleasant, with an informal atmosphere.
You will get the opportunity to learn and contribute across the product life-cycle of the therapies, and to be a key contributor to the success of Vicore Pharma. This requires interest in and knowledge in the area, as well as leadership in general. The position will join study matrix teams and providing high quality medical expertise and leadership.
This is a full-time position and given the existing location of the Vicore Clinical Operations team in Denmark, it is a requirement that the candidate is located in ‘commuter distance’ to Copenhagen region – either in Sweden or Denmark.
Rohit Batta, Chief Medical Officer
To lead (and deliver) the medical and strategic safety input into product maintenance/development planning activities and participate in the Vicore Drug Safety Council.
To contribute to the development of innovative, cost and time effective, and scientifically sound clinical development plans to fit the organisation´s business needs and meet the regulatory requirements, patient, health care and payer needs.
To be overall medically responsible for appointed clinical development programs including, but not limited to, active participation/oversight of medical monitoring of clinical trials including subject eligibility assessment, study design questions and safety data review.
Apply medical and clinical expertise to internal teams and external collaborators.
To ensure up-to date knowledge of current clinical landscape, operational feasibility, and drug approval/access pathways by collaborations with e.g., medical advisors, investigators, patient organizations as well as other relevant external collaborators, partners, funding bodies.
To collaborate with pre-clinical colleagues to assess the need for and design of appropriate pre-clinical experiments to support the clinical development plan.
To contribute and/or provide leadership to the development of regulatory documents e.g., IMPD/IND, Investigator’s Brochures, Risk Management Plans, periodic aggregated safety reports (e.g., DSURs, PSURs), ad hoc safety reports, and briefing documents for scientific advice.
To contribute and/or provide leadership to the development of key clinical trial documents such as clinical trial protocols, master informed consent and clinical trial reports.
To provide medical expertise and/or leadership to e.g., investigator meetings, other trial-related meetings, advisory boards, in- or out-licensing activities and investor presentations.
To contribute and/or provide leadership to the development of publication- and scientific meeting strategy; prepare essential content and coordinate authorship of publications (abstracts, posters, manuscripts, presentations).
To contribute and/or provide leadership to the development of standard operating procedures, inspection readiness, internal training, and guidance documents.
We are looking for candidates with these required skills to achieve our goals:
Medical degree (MD).
Experience (>8 years) from the pharmaceutical and/or biotechnology industry working with the clinical development of investigational new drugs.
Experience in ICH GCP and knowledge of relevant legal requirements for clinical development activities.
Experience as the Sponsor’s medical expert responsible for oversight of trials managed through global clinical outsourcing.
Submission experience with writing of regulatory documents and interactions with Health Authorities.
Ability to communicate information clearly and lead interactions/presentations in scientific and clinical settings.
A background in pulmonary diseases and/or rare diseases is an advantage, together with expert knowledge of relevant pharmacovigilance regulations.
A high level of pro-activity, commitment, and energy.
Strong leadership and coaching skills.
Excellent problem-solving skills and a “can do attitude”.
Strong individual initiative, organization skills and multi-tasking abilities.
Open personality and easy to work with.
If you believe you have the experience and qualities we are looking for, please either apply here with a complete application (motivation letter, CV) or contact Kristina Edholm for a confidential discussion (firstname.lastname@example.org). Please do not submit any documents via email due to GDPR reasons. Interviews are taking place, so please get in touch or apply at your earliest convenience.
Read more about Global Medical Diector here!