Medical Director in M&S Obesity

Be our new Medical Director in M&S – Obesity

Currently, we are looking for one or more (Senior) Medical Directors who have a medical background and experience from conducting and designing pharmaceutical industry trials. You understand drug development programs and the associated regulatory framework and preferably you have a track record within obesity. We are looking for a self-driven team-oriented colleague with the capability to informally lead cross-functional teams towards innovative solutions for delivering the highest standard clinical development trials for our drug candidates. We offer a unique culture, based in the Zealand Pharma’s DNA where we are bonding to discover, design and develop innovative peptide-based medicines to change the lives of patients If this sounds like you, and you are ready to take on a broad area of responsibilities with an independent attitude, you are a match for us.​

Responsibilities

• Create and guide clinical development plans for selected projects, in close collaboration with the project teams
• Create clinical trial outlines ensuring fit for purpose design excellence in accordance with strategy and the needs of the assigned drug development projects.
• Act as Zealand’s medical expert for selected clinical projects and trials
• Provide medical subject matter expertise to the clinical and projects teams as appropriate; liaise with other drug development disciplines regarding the conduct of trials, statistical methodology, data analysis, interpretation and reporting, and regulatory issues
• Support execution of the strategy and other project related tasks on-time and with the highest quality
• Support the clinical team in executing the clinical development plan
• Ensure proper medical monitoring, including when the role is delegated to appropriately qualified medical personnel, such as outside consultants or CROs in accordance with SOPs
• Work in accordance with applicable guidelines and regulatory plans/regulatory advice to ultimately support marketing authorizations
• Write essential part of the documentation required to support conduct of the clinical program and the documentation required to respond to regulatory agencies regarding any clinical queries and for product approval by regulatory agencies
• Provide relevant post-approval medical and life-cycle support

Candidate profile

You will have most or all the below qualifications:

• Medical education is required, specialization not necessary
• Proven pharma experience with hands on drug development experience, incl. preparing clinical trial plans, development plans, clinical pharmacology trials or later stage trials
• Experience within the field of obesity is preferred. Alternatively, knowledge about metabolic/endocrine/cardiovascular disease areas would be an advantage
• Scientific experience within relevant areas, PhD or equivalent is ideal
• Proven ability to drive and lead scientific project sub-teams towards results in a complex scientific field or in a pharmaceutical organization
• Experience from a lead medical role or similar is an advantage
• Experience with regulatory affairs, regulatory agency meetings and drug registration is preferred
• You must be able to work independently and actively contribute as a highly collaborative team player
• You must have skills for project management and be able to get people on board in your team