Scientific Director/Senior Scientific Director, Medical Affairs - Psychiatry

Job Description

Purpose :

• Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as : healthcare professional / provider interactions (HCPs, Patients and Payers);
• generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data and value proposition);

safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical / marketing activities (promotional material generation / product launches) and market access.

Drives Medical Affairs input into and influences the development of asset strategy. Provides specialist medical insights, and executes on data generation, communication, and expert engagement activities as deliverables to relevant Asset Strategy Teams (ASTs) for both early and late-stage development program including leading or contributing to : comprehensive gap assessment, development of Scientific Communication Platform, development of integrated evidence plans to support launch readiness.

Leads external stakeholder interactions (HCPs, Patients and Payers). Drives scientific communication initiatives (both internal and external medical education, data, guidelines and value proposition).

Responsibilities :

In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, HEOR and other functional areas, provides leadership, oversight, and support for assigned indications / projects.

Works closely with Brand Teams and relevant cross-functional, area / affiliate medical teams, to provide strategic input into core asset strategy, and to drive medical activities.

Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.

Develops innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally.

Provides scientific and technical support for assigned assets; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders;

actively participates in relevant Asset, Development and Pipeline Commercial cross-functional teams and drives the development of medical affairs objectives aligned with strategy.

Provides scientific and technical input to inform the development of the Asset Target Product Profiles (TPP). Provides input in design and execution of Phase II-III trial programs including target population and endpoint selection aligned with TPP.

Works cross functionally to lead the development of the asset Phase 3b / 4 strategy.

• Reviews, assesses and reports applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
• Leads the development and execution of advisory boards, scientific and medical education programs. Provides scientific / medical education to all relevant internal stakeholders related to therapeutic area or disease specific information.
• Keeps abreast of professional information and technology through conferences and / or medical literature and acts as a specific therapeutic area resource.

Initiate research projects and drive them to completion, resulting in high quality publications.

• Lead functional and cross functional teams responsible for discrete projects within the specific therapeutic area (data analysis, expert engagement, individual publications, study collaborations)
• Represents Medical Affairs in due diligence activities for the acquisition of assets aligned with the Disease Area Strategy.
• Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.

Qualifications

Qualifications

• Advanced Degree PhD, MD or PharmD. Additional post doctorate experience highly preferred.
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Must possess excellent oral and written English communication skills.
• Ability to interact externally and internally to support global business strategy.
• Proven ability to run a clinical study or medical affairs cross-functional team independently.
• Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent.

4+ years of experience is preferred.

Qualifications for Scientific Director

Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.

7-10 years of experience in Medical Affairs preferred

• Strong knowledge in Psychiatry therapeutic area
• People leadership experience preferred

Qualifications for Sr. Scientific Director :

• Typically, 15 years’ experience in the pharmaceutical industry or equivalent. Minimum of 10 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
• Expert knowledge in Psychiatry therapeutic area
• People leadership experience required

Additional Information

All your information will be kept confidential according to EEO guidelines.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.