Medical Director, Medical Affairs Psychiatry
No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.
For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.
The Medical Director, Medical Affairs Psychiatry will serve as the internal medical and scientific expert for assigned psychiatry product(s), driving key medical strategies and tactics which align with Brand and Disease State strategy, building and growing strong advocacy relationships and ensure accurate, robust and appropriate medical/scientific exchange of knowledge and clinical expertise with all stakeholders in the therapeutic area, being the internal medical/scientific point-person for all other programs (Global, Clinical Development, Health Outcomes, Scientific Communications, Regulatory, Brand Teams, etc.) necessary to reach corporate objectives and goals.
* Drives medical strategies (e.g., leading, developing, implementation and execution of key medical initiatives) which would align with the strategy of the Brand(s)/Disease State in the Psychiatry therapeutic area.
* Participates in clinical proposal process including review of proposals and protocols of approved studies while supporting Clinical Research operational and health economics/outcomes teams.
* Leads the assessment, selection, and implementation of funding and legal agreements for Investigator Initiated Trials (IITs).
* Provides US scientific and strategic input to the global Psychiatry state strategy teams.
* Provides US strategic input to the Lundbeck Psychiatry products clinical development plan based on the clinical and scientific knowledge and expertise and strong network in the US Psychiatry medical community.
* Maintains and further develops relationships and network with key opinion leaders in the psychiatric scientific community
* Maintains and builds productive relationships with investigators, thought leaders and centers of excellence across the psychiatric scientific community, as well as with global colleagues.
* Reviews business development opportunities, translating business needs to cost-effective development strategies that provide a competitive advantage and meet regulatory requirements.
* Supports regulatory interactions, including the submission of regulatory documents and presentations.
* Serves as a medical and scientific expert, and works closely with the Pharmacovigilance group within Lundbeck US.
* Serves as a member of the safety committee.
* Participates in budgetary processes as part of annual business planning and review of expenses within US Medical.
* Provides medical input into Promotional Advertising Review Committee for all promotional and external materials, and participation in Labeling meetings, where appropriate, with sign-off authorization.
* Is involved in and develops SOPs for the activities conducted by Medical Affairs; ensuring all activities are in compliance with ICH and other international regulatory guidelines and follow relevant GCPs and SOPs.
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
* Accredited MD, with clinical experience in Psychiatry therapeutic area.
* Minimum 5 years of progressive medical/scientific affairs experience within the pharmaceutical or biotech industry, or clinical experience within academia or psychiatry practice.
* Ability for building partnerships and working collaboratively with others to meet shared objectives.
* Strong interpersonal skills to work closely with both external physicians/scientists and in-house cross-functional teams
* High proficiency in problem solving ability and strong scientific analytical skills
* Excellent planning and organization skills.
* Ability to maintain the highest degree of confidentiality and integrity, representing the company’s high ethics, moral behavior, and professionalism.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
* Specialty training in psychiatry (board certification or eligibility in psychiatry).
* Experience in managing and/or conducting clinical studies.
* Direct involvement with the FDA.
* Knowledge and experience in appropriate therapeutic area(s).
* Management and professional development of staff at several levels.
* Experience with copy approval and promotional review.
* Professional society membership(s) relevant to psychiatry.
* Regulatory knowledge and exposure, including experience with international regulations relating to cGCP, conduct of clinical trials overseas and demonstrated ability to manage projects internationally
* Willingness/Ability to travel up to 30% domestically. International travel may be required.