Director, Medical Affairs

BACKGROUND:

Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd. (Zydus), is a commercial stage biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases. With an emphasis on commercialization, Sentynl looks to acquire, develop and commercialize well-differentiated products across a broad spectrum of therapeutic areas to address a variety of genetic, orphan and neurological disorders. To support its latest acquisitions, Sentynl is searching for a Director, Medical Affairs.

SUMMARY:

The Director, Medical Affairs position is a high growth role with the opportunity to expand capabilities and gain tremendous “hands-on” experience across the department and with the entire organization. This is a unique role that is a blend of daily oversight of outsourced Medical Information, Pharmacovigilance, and the Expanded Access Programs, as well as management of Scientific Communications.  While the role is expansive, you will work very closely with the Head of Medical Affairs as a key strategic and implementation partner. Additionally, the Director, Medical Affairs will collaborate closely with both internal and external stakeholders in a small, nimble organization to support Sentynl’s commercial and development-stage products. This role will be a balance of leadership, “do-it-yourself” and oversight of external consultants.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Oversee and manage Medical Information (MI) to ensure the medical information request process is operating at the highest scientific and medical data/content standards and all necessary follow-up is conducted in a compliant and timely manner.
  • Develop Standard Response Documents (SRDs) in conjunction with Medical Information partner
  • Oversee and manage Pharmacovigilance (PV) activities to maintain seamless integration with Medical Information and other intake/reporting routes of Adverse Events (AE) and Product Complaints (PC) such that the overall process is compliant and efficient, including the following:
    • Monitor PV system performance and compliance of partners to ensure that PV vendors are performing in line with contracted obligations.
    • Supervise AE and PC intake and management to ensure AEs/PCs are assessed, documented, processed, and reported on time and according to appropriate regulations and Sentynl standards.
    • Act as the main contact person internally and externally, for safety-related aspects and PV, including training of PV vendors.
    • Ensure internal PV processes and procedures are well documented and support compliant regulatory/PV activities.
    • Provide guidance and oversee deliverables related to risk management (e.g. RMPs) and benefit/risk assessments.
  • Supervise Early Access Program medical inquiry triaging and response execution.
  • Ensure MI, PV, and EAP vendors are up-to-date with new or revised medical/scientific content inclusive of USPI label updates, key scientific literature/publications, etc. such that medical responses and FAQ documents are accurate. This includes the update to and expansion of SRDs when necessary.
  • Develop and lead the medical communication plan for Sentynl’s products, including the following activities:
    • Represent Medical Affairs at medical congresses and external associations as needed to staff MI booth and collect relevant scientific information.
    • Provide expert product and therapeutic area medical expertise, as well as relevant scientific information in response to customer stated inquiries.
    • Support scientific training of MSLs and other Sentynl team members as appropriate.
    • Establish and maintain appropriate collaborations with external scientific experts, thought leaders, and advocacy groups in accordance with Sentynl compliance policies.
    • Support strategy and provide medical expertise in US and ex-dossiers as needed.
    • Support the implementation and execution of a comprehensive publication plan and manage the creation of abstracts, posters, oral presentations, and manuscripts for Sentynl’s products and maintain relationships with healthcare professionals (HCPs) and key opinion leaders (KOLs) regarding ongoing collaborations.
    • Develop and drive an integrated global congress plan, coordinating coverage and communication of key competitive data.
  • Periodically assess, in conjunction with the Medical Affairs and Regulatory Heads, programmatic quality and gap assessments of the Medical Information, PV, and EAP programs.
  • Ensure all assigned Medical Affairs activities are conducted in full compliance with all legal, regulatory and company requirements.

KNOWLEDGE/SKILLS/ABILITIES

  • Pervasive focus on helping patients.
  • Excellent interpersonal skills with a demonstrated track record of achieving results and optimizing team performance while adhering to the highest medical and ethical standards.
  • Strong business acumen with a proven ability to execute complex plans and manage budgets and resources responsibly.
  • Ability to work independently and as part of a team with a strong sense of urgency.
  • Adeptness at building collaborative relationships with internal and external stakeholders.
  • Demonstrated leadership, problem solving, and conflict resolution skills.
  • Strong understanding of industry, compliance, and regulatory frameworks and trends.
  • Understanding of the complexities and regulations of drug development, drug commercialization, launch and lifecycle management as well as the proven ability to translate medical insights into relevant strategies, tactics and operational plans for the medical affairs function.
  • Possession of strong ability and scientific curiosity to develop and continuously maintain the highest scientific and medical expertise in order to be a respected thought-partner to external academic scientists and clinical experts.
  • Management of consultants and vendors.

EDUCATION/EXPERIENCE

  • Medical Information and PV experience required.
  • Advanced degree (MD, PhD, or PharmD) required.
  • Background in genetics, pediatrics, neurology, and/or rare disease strongly desired.
  • Minimum of 6 years of experience in Medical Affairs, with at least some experience working in a small and growing biotech company.
  • Strong experience with medical communication, publications and conference planning.
  • Successful product launches in the US, ex-US experience preferred.
  • Experience with diagnostics, including newborn screening programs, is preferred.
  • Direct interactions or demonstrated understanding of engaging with payer organizations, health technology assessors, and/or regulatory agencies.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job.

  • Normal office conditions.
  • Routine travel will be required between various locations in US and occasional international travel. Up to 30% travel.

CORE VALUES & COMPETENCIES

Growth

  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation

Accountability

  • Results Oriented
  • Ensures Accountability
  • Decision Quality

Transparency

  • Courage
  • Collaboration
  • Instills Trust

Ethics

  • Compliant
  • Unwavering commitment to doing what is right
  • Seeks guidance when unsure

 

Sentynl Therapeutics, Inc. offers a competitive salary program and an attractive benefits package that includes:

  • Medical/Dental/Vision Insurance
  • Company paid Life Insurance, Short-term Disability and Long-term Disability
  • 401(k) plan with a generous employer match
  • Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.
  • Paid Holidays

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