At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global pharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.
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:
Minimum 5 years of progressive medical/scientific affairs experience within the pharmaceutical or biotech industry, or psychiatry clinical experience within academia or a 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) and/or clinical experience in Psychiatry therapeutic area
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.
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employement opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
At Lundbeck, our mission is to improve the quality of life of people suffering from psychiatric and neurological disorders.
As a pioneer at the forefront of brain disorders for more than 60 years, Lundbeck is committed to developing and providing innovative therapies that help improve the quality of life of patients. This is important work because the burden of neurological and psychiatric disorders remains substantial. When we assess a medical condition, we see the person behind the disease and how it affects the lives of patients, their families, their caregivers and their communities.
What sets us apart:
Research: A deep pipeline – 100 percent targeted to brain disorders – in challenging areas like depression and anxiety, psychosis, epilepsy, Alzheimer’s disease and stroke.
Patients:A passion for patients that binds us together and drives us to act with urgency to address unmet medical needs today and into the future.
Partnerships:A long history of successful and diverse partnerships at all stages of a product’s lifecycle